NaavudiFIRST NATURAL
INSULIN-MIMETIC
Information
Booklet
Information
Booklet
I N P U R S U I T O F
H E A L T H I E R
M A N...
Preface
Diabetes Mellitus (DM) represents a major medical problem
affecting millions of people all over the world. Diabete...
First Natural
Insulin Mimetic Naavudi
StandardizationofHerbalFormulation
Formulation
Naavudi has been standardized in term...
First Natural
Insulin Mimetic Naavudi
Cis-2 [3-4 dihydroxy-phenyl] 3-4, dihydro-2H-1, benzopyran-3,5,7 triol
RoleofHerbalI...
First Natural
Insulin Mimetic Naavudi
ClinicalTrialReport
Follow-upStudies
Observations & Result
A clinical trial has been...
First Natural
Insulin Mimetic Naavudi
TM
EffectofNaavudi onSubjectiveSymptoms
TM
EffectofNaavudi onBodyMassIndex
Safety
T ...
EffectofNaavudionSerumCholesterol
TM
Effect of Naavudi
TM
on Serum Creatinine & Blood Urea EffectofNaavudi onHaemoglobin
T...
EffectofNaavudionSerumCholesterol
TM
Effect of Naavudi
TM
on Serum Creatinine & Blood Urea EffectofNaavudi onHaemoglobin
T...
First Natural
Insulin Mimetic Naavudi
TM
EffectofNaavudi onSubjectiveSymptoms
TM
EffectofNaavudi onBodyMassIndex
Safety
T ...
First Natural
Insulin Mimetic Naavudi
ClinicalTrialReport
Follow-upStudies
Observations & Result
A clinical trial has been...
First Natural
Insulin Mimetic Naavudi
Cis-2 [3-4 dihydroxy-phenyl] 3-4, dihydro-2H-1, benzopyran-3,5,7 triol
RoleofHerbalI...
First Natural
Insulin Mimetic Naavudi
StandardizationofHerbalFormulation
Formulation
Naavudi has been standardized in term...
Preface
Diabetes Mellitus (DM) represents a major medical problem
affecting millions of people all over the world. Diabete...
NaavudiFIRST NATURAL
INSULIN-MIMETIC
Information
Booklet
Information
Booklet
I N P U R S U I T O F
H E A L T H I E R
M A N...
of 14

Naavudi - CLE Holistic Health

Naavudi offers safe, natural and organic way of maintaining blood sugar with its revolutionary glucose support.
Published on: Mar 3, 2016
Published in: Health & Medicine      
Source: www.slideshare.net


Transcripts - Naavudi - CLE Holistic Health

  • 1. NaavudiFIRST NATURAL INSULIN-MIMETIC Information Booklet Information Booklet I N P U R S U I T O F H E A L T H I E R M A N K I N D Commodity Link Enterprises (CLE) Naavudi Health Blood Sugar Support Visit us at www.Naavudi.com
  • 2. Preface Diabetes Mellitus (DM) represents a major medical problem affecting millions of people all over the world. Diabetes is a metabolic disorder in which the body does not produce or properly use insulin, a hormone responsible for converting sugar,starchandfatsintoenergyneededfordailylife. The two distinct forms of DM are, Type I, juvenile or Insulin Dependent Diabetes Mellitus (IDDM – an auto immune disease in which body does not produce any insulin) andType II, adult onset or Non Insulin Dependent Diabetes Mellitus (NIDDM – a metabolic disorder resulting from the body's inabilitytomakesufficientorproperlyuseinsulin). However, since there are more adult onset cases (NIDDM–90–95%) than juvenile ones (IDDM-5-10%); TypeIIneedsmoreattention. Despite a significant improvement over the past two decades in our understanding and treatment of Diabetes Mellitus many aspects about the subject need to be elucidated, because the management and treatment of Diabetes Mellitus still remains one of the major challenges for the medical profession. Looking at the inconveniences and agony of persons suffering from diabetes and trying out various medicaments, developing diabetic neuropathy, increasing renal load and various other complications like haematological disorders, cardiovascular complications, weight loss, lactic acidosis and retinopathy etc., the Research and Development team of Naavudi started workingonherbalremedyfordiabetes. On a prolonged study it was found that 'Epicatechin' which is found in abundance naturally in wood commonly known as Vijaysar, (Pterocarpus marsupium) mimics insulin in its action. Encouraged by the finding, the team continued to work on developing a combination of herbs and natural products which would be synergistically beneficial to a diabetic patient as a whole. The objective was not only to take care of blood glucose level but also to take care of other peripheral problems associated with it, which cause major distresstothepatient. Bibliography and References 1. Ahmed et al, 1991, Indian Journal of Experimental Biology 24,516-520. 2. AnsorgeS,etal,Acta.Biol.Med.Germ.36(1997),1723. 3. BansalRetal,ActaDiabetol,17(1980)255. 4. Rizvietal,(1995)IndianJournalofExperimentalBiology33. 5. Rizvietal,(1998)MedicalScienceResearch26,245-249.
  • 3. First Natural Insulin Mimetic Naavudi StandardizationofHerbalFormulation Formulation Naavudi has been standardized in terms of "Epicatechin", an active principleof thisformulation. The first step adopted towards attaining quality and consistency is the strict adherence to the rigorous standardized procedure that are followed in the collection of Pterocarpus marsupium. Proper identification and selection of the herb, proper time of the year for harvest, proper maturity of the bark of the plant used are the three most important specifications set, that are used for the collection and standardizationof alltheherbsused. After proper selection of the herbs, each and every herb is subjected to the rigid standards like assessment of foreign organic matter, water soluble extractive, ethanol soluble extractive, moisture content, microbial contamination and chromatographic finger printing. After proper quality assessment of each and every ingredient, they have to undergo processing. Processing of the herb and active ingredient involve proprietary know-how. In Naavudi the active ingredient has been extracted, processed concentrated by a unique technique so that the goodness of whole constituent is incorporated in onecapsule. After successfully developing the combination (formulation), Naavudi was standardized in terms of moisture content, total extractable component, foreign organic and inorganic impurities, total microbial load, active principle 'Epicatechin'; distintegration time, weight variation of the capsule etc.. To make the consistency of the formulation (which is the major problem in herbal formulation) 'finger printing' of the formulation has been developed in terms of specific marker, which is the 'key' of the formulation. Apart from this, the formulation has also been tested in terms of its 'efficacy' under different stressedconditions. Institute of Toxicological Research Centre, Lucknow for acute toxicity studiesand hasbeenfoundtotallyfreefromanysideeffects. Naavudi capsule has been scientifically formulated to create a better, balanced,complementaryand non toxicmedicine. Composition Proprietary Blend across Composition Doctor's Observations on NAAVUDI in Diabetes Mellitus "It does not increase weight rather it decreases B.M.I. It decreases significantly PPBS in type II Diabetes Mellitus. It decreases the requirement of O.H.Ds / Insulin if usedincombination." — Dr. Chakrapani Pandey, M.D., F.C.C.P. 1, M.P. Building Golghar Gorakhpur "The response of NAAVUDI on the patients is satisfactory. During treatment therewasnohypoglycemiaoranyothercomplication." — Dr. Chakrapani Pandey, M.D., F.C.C.P. 1, M.P. Building Golghar Gorakhpur "My blood sugar fasting before NAAVUDI (treatment) was 265 mg %. After one monthbloodsugarwas180mg%.Now bloodsugarisnormal." — Dr. Z.A. Noor, B.M.S. Dhampur Road, Nehtaur, Distt. Bijnore "I tried NAAVUDI capsules on my mother. She was taking glybenclamide 5 mg. OD and metformin 500 mg BID half an hour before meals. She is normal from 1st day(of treatmentwithNAAVUDI)and physicallyfit." — Dr. Fahimuddin Ansari, B.Sc.; B.A.M.S. Raja Ka Tajpur, Distt. Bijnore 246735
  • 4. First Natural Insulin Mimetic Naavudi Cis-2 [3-4 dihydroxy-phenyl] 3-4, dihydro-2H-1, benzopyran-3,5,7 triol RoleofHerbalIngredients Physiology & Pharmacology of Active Principles Pterocarpus marsupium : Regenerates cells, mimics insulin, checks blood sugar level. Momordica charantia Linn : Astringent, controls blood sugar level. Cinnamomum tamala : Diuretic, increases blood insulin, stimulates pancreas. Eugenia jambolana : Diuretic, antidiabetic. It diminishes the quantity of sugar in urine; allays the unquenchable thirst. Melia azadirachta : Checks basal metabolism and body sugar level. Picrorrhiza kurrooa : Checks basal metabolism, bitter tonic, corrects the function of liver and kidney. Ocimum sanctum : Diaphoretic, stimulant, anti- stress, adaptogenic. Gymnema sylvestre : Hypoglycemic agent, diuretic, have an oxidase action on glucose solution and shows glycolysis. The whole formulation of Naavudi is based on an active principle 'Epicatechin' which is at the core of the total product. Other ingredients are added to prevent and cure the different complications of diabetes. It controls the metabolicderangementsratherthan merecontrolof blood sugarlevel. Epicatechin the active principle of Naavudi is extracted from the bark of P.marsupiuminahighlyscientificmanner. Epicatechin isabenzopyran havingthefollowingorganicstructure. Thisactiveprinciplecontrolsdiabetesinthefollowingmanner: Epicatechin increases the cAMP content of the islet which is associatedwithincreasedinsulinrelease. Epicatechin plays a role in the conversion of proinsulin to insulin byincreasingcathepsin activity. Epicatechin plays an insulin-mimetic effect on osmotic fragility of human erythrocytes. Epicatechin inhibits Na/K ATPase activity on patient's erythrocytes,an effectsimilartothatof insulin. A B C D OH OH OH OH HO EvaluationofNAAVUDIasadjuvanttoOHD (OralHypoglycaemicDrugs) Observation NAAVUDI was added in the drug-regimen in patients who were not responding to OHD (Pioglitazone, Metformin, Glibenclamide, Gliclazide taken alone or as combination of these drugs). The hypoglycaemic effect of NAAVUDI is established since addition of NAAVUDI with OHD brought down the blood sugar level to normal withtaperingof OHD requirementtoalmosthalf within2months. T A B L E - 9* Dt.ofTesting Treatment TotalDaily BloodSugarLevel Dose mg% Fasting P.P 01.01.2002 Pioglitazone 30mg 30mg Melformin 500mg TDS 1500mg 154 203 25.02.2002 Naavudi 1 BD 2 Caps. Piogitazone 15 mg OD 15 mg Metformin 500mg OD 1000mg 122 178 05.03.2002 Naavudi 1 BD 2 Caps Pioglitazone 15mg OD 15mg Metformin 500mg OD 500mg 95 150 Dr. Prakash Sharma, M.B.B.S New Colony, Pratapgarh-230 001 T A B L E - 10* Dt.ofTesting Treatment TotalDaily BloodSugarLevel Dose mg% Fasting P.P 15.11.2001 Glibenclamide 5 mg BD 10 mg 292 31.12.2001 Glibenclamide 5 mg OD 5 mg Naavudi 1 BD 2 Caps. 201 01.02.2002 Glibenclamide 2.5 mg OD 2.5 mg Naavudi 1 BD 2 Caps. 150 02.03.2002 Glibenclamide Nil Naavudi 1 BD 2 Caps. 126 Dr. Zameer Ahmed, B.Sc.; M.B.B.S Turkmanpur, Gorakhpur-273 005 NAAVUDI has hypoglycaemic effect in NIDDM cases. By adding NAAVUDI to the therapy the dose of oral hypoglycaemic drugs is reduced or the same can be discontinued depending upon individual patient.
  • 5. First Natural Insulin Mimetic Naavudi ClinicalTrialReport Follow-upStudies Observations & Result A clinical trial has been conducted to evaluate the efficacy of Naavudi in the treatment of Non Insulin Dependent Diabetes Mellitus (NIDDM) at Sir Sunder Lal Hospital by Dr. K.N. Devendra, Consultant – Diabetic Clinic (I.M.), Institute of Medical Sciences, Banaras Hindu University, Varanasi. Dr. K.N. Devendra is a member of Diabetic Association of India (DAI), Research Society for Study of Diabetes in India (RSSDI) and Indian Societyof WoundManagement(ISWM). A number of diagnosed patients of Non Insulin Dependent Diabetes Mellitas (NIDDM) were selected for present study from the Out Patient Department (OPD) and In-door of he diabetic clinic, (Indian Medicine), Sir Sunderlal Hospital, Institute of Medical Sciences, Banaras Hindu University,Varanasi. All the patients were examined clinically for the signs and symptoms of Diabetes Mellitus and subjected for routine Bio-chemical investigations asperclinicalprotocol.Self controlmethodwasusedinthisclinicaltrial. All the patients were assessed on clinical and bio-chemical parameters periodically at the interval of one month, two months & threemonths. PARAMETERSOFASSESSMENT Assessmentwasdoneon objectiveand subjectiveparameters. Parametersof Objectiveassessmentwere: ReductioninFastingand Post-PrandialBloodSugarLevel Desirablechangeinthestatusof BodyMassIndex(BMI) ChangesinHaemoglobin Level ChangesinLevelsof SerumCholesterol ChangesinLevelsof BloodUreaand SerumCreatinine Parametersof Subjectiveassessmentwere: Thegentlehypoglycemicactivitybynaturalingredients DOSAGE All the patients were given 1 Naavudi capsule twice daily 30 minutes beforemeals. EFFECTOFNAAVUDIONBLOODGLUCOSELEVEL It was observed that among all the patients who completed 3 months treatment,theBloodGlucoseLevelfellsignificantly. Precautions MulticentrictrialinNIDDMpatients Multicentric trial of NAAVUDI in newly diagnosed NIDDM,withmildtomoderatebloodsugarlevels l Avoid Sweets, Creams, Butter, Cheese, Jams, Pastry & Jellies. l Avoid taking fatty and fried food stuff with excessive spices. l Regular morning walk and mild exercise like yoga helps in effectivecontrolof diabetes. l Bloodsugarlevelsshouldbemonitoredperiodically. Encouraged by the results of clinical evaluation of the beneficial role of NAAVUDI in the management of diabetes in NIDDM patients at IMS, B.H.U, Varanasi, NAAVUDI was offered to many doctors in different cities for first hand evaluation of the novel concept of 'Insulin mimetic effect of naturally found Epicatechin'. Doctors who were looking for a natural alternative to modern OHD available because of long term side effects being observed by them accepted NAAVUDI and tried on their patients who were either new cases not responding to dietary controls and exercises or who were on different OHD, singularly or in mixeddoseregimen.The data receivedbythesedoctorswas statistically analysed which presents a very satisfactory finding that NAAVUDI is quite effective in those cases also where the patients were on modern OHD and ultimately leading to total elimination of the dependence on modern OHD to NAAVUDI which being a naturally derived product is free from any long term side effects and on the contrary patients reported distinctiveimprovementin'qualityof theirlife'. Sixty patients with a mean blood sugar level of 172 mg / dl (fasting) and 264 mg / dl (post prandial) were put on NAAVUDI one capsule b.i.d. half an hour before meals. Fall in blood sugar level was seen from the first month of therapy and at the end of third month blood sugar level came down to normal. None of thepatientshad reportedanysideeffects. Before Treatment After 3 Months Treatment P. Value 1. 170.37 109.80 <0.001 Blood Glucose Level Fasting Blood Sugar (Mean Value in mg%) 2. 243.93 167.77 <0.001 Post-Prandial Blood Sugar (Mean Value in mg%) T A B L E - 1
  • 6. First Natural Insulin Mimetic Naavudi TM EffectofNaavudi onSubjectiveSymptoms TM EffectofNaavudi onBodyMassIndex Safety T A B L E - 6 S.No. Symptoms PercentageImproved 1. Polyuria 100 2. Polydipsia 100 3. Increasedappetite 100 4. Weakness 90 5. Fatigue 90 The Post-Prandial Sugar Level which was 243.93 mg% (Before 6. Feelingof coldinhand and feet 100 treatment) was reduced by Naavudi to 164.77 mg% at the end of three 7. Burning sensation 89 months therapy which falls within the normal range. The statistically significantefficacyof thedrugisevidentbyitsPvalue(<0.001).8. Numbness 100 It was observed that, Naavudi has moderately good hypoglycaemic9. Paraesthesia 80 action exhibiting persistent glycaemic control with a slow onset of 10. Muscularpain 100 action thus keeping away the danger of drug induced-hypoglycaemia. It Above table shows that there was marked improvement in subjective is notable that no case of drug induced-hypoglycaemia was observedduringthetrial.symptoms. Besides this, a better sense of well being was observed in all the patients. On the basis of the above results this can be concluded that Thus Naavudi is very much useful in controlling Blood Glucose Level Naavudi can also be used in Insulin Dependent Diabetes Mellitus without any side effects in cases of maturity onset Non-Insulin (IDDM) as an adjuvant which in turn will be helpful in reducing the DependentDiabetesMellitusof mildtomoderateseverity. dosageof Insulinand otherhypoglycaemicdrugs. Marked improvement in symptoms along with a better sense of well Body Mass Index (BMI) is a number calculated by looking at weight inbeing was experienced by all the patients. This may be due to better relation to height and is the most common parameter to define obesityglycaemic control exerted by Naavudi or we may say that these are the whichisamostprevalentriskof DiabetesMellitus.specific Ayurvedic natural constituents of Naavudi which in addition toadequateglycaemiccontrol,inducesabettersenseof wellbeing. PRESENTATION:Stripsof 10capsules. l Naavudi is derived from vegetable and herbal sources and manufactured in a highly scientific manner, hence it is very safe for personsof anyage. l Acute oral toxicity study of Naavudi has been conducted at Institute of Toxicological Research Centre (I.T.R.C.), Lucknow. Dosage (mg/kg) Dead/Dosed Death Signs of Toxicity 5000 0/5 NIL NIL As evident from the Table - 2 & Figure - 2, the mean Body Mass Index (BMI) of the patients was 25.96 indicating that majority of the patients were overweight. Naavudi reduced their BMI up to a mean of 24.88Naavudi at a limit dose of 5000 mg/kg has not produced any signs of indicating a reduction in BMI value towards normal range. P valuepoisoning or death of animals. Autopsy of the surviving animal at the (<0.01) depicts that Naavudi is statistically significant in reducingend of the observation period did not indicate any gross pathological theBMI.changes. As is evident from the Table - 1 & Figure - 1, that the Fasting Blood Sugar Level was reduced by Naavudi from the pre-treatment value of 170.37 mg% to the level of 109.80 mg% at the end of three months therapy. The P value (< 0.001) shows statistically promising significance of thedruginreductionof FastingBloodSugarLevel. T A B L E - 2 Before Treatment After 3 Months Treatment P. Value 25.96 24.88 <0.001Body Mass Index (BMI) F I G U R E - 2 26.50 26.00 25.50 25.00 24.50 24.00 Before Treatment After 3 Months Treatment 25.96 24.88 Effect of Naavudi on Blood Sugar Effect of Naavudi on BMI
  • 7. EffectofNaavudionSerumCholesterol TM Effect of Naavudi TM on Serum Creatinine & Blood Urea EffectofNaavudi onHaemoglobin Table – 3 & Figure – 3 shows that Serum Cholesterol level was As it is evident from the Table – 4 and Figure 4 & 5; that the Blood urea significantly reduced by Naavudi in three months from a mean level 38.23 mg% which was towards external limit of normal range was value of 229.90 mg% to 194.03 mg% thus it also reduces the reduced significantly up to the level of 33.23 mg% at the end of three chance of Ischaemic Heart Disease among diabetic patients. months. This is indicative of Naavudi’s efficiency to improve the Reduction in Serum Cholesterol level show that in addition functions of kidney as well as its reno-protective action. In addition to to hypoglycaemic action Naavudi also has Cardio-protective above, reduction of the Serum Creatinine value from 1.57 mg% to 1.32 benefits. mg% again depicts Naavudi’s role in reno-protection and in the improvementof renalfunction Increased Serum Creatinine & Blood Urea leads to Nephropathy which isoneof themajorconsequencesof DiabetesMellitus. Table – 5 and Figure – 6 illustrates that haemoglobin level was significantly improved by Naavudi from a mean value of 11.58 gm% to 13.27 gm% during three months therapy which indicates restoration of positivehealthof thepatient. Naavudi 1.60 Effect of Naavudi on Serum Creatinine After 3 Months Treatment MeanValueinmg% 1.55 1.50 1.45 1.40 1.35 1.30 1.25 1.20 1.15 F I G U R E - 4 ( B ) Before Treatment 1.57 1.32 Before Treatment After 3 Months Treatment P. Value 11.58 13.27 <0.001 Haemoglobin (Mean Value in gm%) T A B L E - 5 Effect of Naavudi on Haemoglobin Before Treatment After 3 Months Treatment MeanValueinmg% 14.00 13.50 13.00 12.50 12.00 11.50 11.00 F I G U R E - 5 10.50 13.27 11.58 First Natural Insulin Mimetic 4 ( A ) Effect of Naavudi on Serum Cholesterol Effect of Naavudi on Blood Urea
  • 8. EffectofNaavudionSerumCholesterol TM Effect of Naavudi TM on Serum Creatinine & Blood Urea EffectofNaavudi onHaemoglobin Table – 3 & Figure – 3 shows that Serum Cholesterol level was As it is evident from the Table – 4 and Figure 4 & 5; that the Blood urea significantly reduced by Naavudi in three months from a mean level 38.23 mg% which was towards external limit of normal range was value of 229.90 mg% to 194.03 mg% thus it also reduces the reduced significantly up to the level of 33.23 mg% at the end of three chance of Ischaemic Heart Disease among diabetic patients. months. This is indicative of Naavudi’s efficiency to improve the Reduction in Serum Cholesterol level show that in addition functions of kidney as well as its reno-protective action. In addition to to hypoglycaemic action Naavudi also has Cardio-protective above, reduction of the Serum Creatinine value from 1.57 mg% to 1.32 benefits. mg% again depicts Naavudi’s role in reno-protection and in the improvementof renalfunction Increased Serum Creatinine & Blood Urea leads to Nephropathy which isoneof themajorconsequencesof DiabetesMellitus. Table – 5 and Figure – 6 illustrates that haemoglobin level was significantly improved by Naavudi from a mean value of 11.58 gm% to 13.27 gm% during three months therapy which indicates restoration of positivehealthof thepatient. Naavudi 1.60 Effect of Naavudi on Serum Creatinine After 3 Months Treatment MeanValueinmg% 1.55 1.50 1.45 1.40 1.35 1.30 1.25 1.20 1.15 F I G U R E - 4 ( B ) Before Treatment 1.57 1.32 Before Treatment After 3 Months Treatment P. Value 11.58 13.27 <0.001 Haemoglobin (Mean Value in gm%) T A B L E - 5 Effect of Naavudi on Haemoglobin Before Treatment After 3 Months Treatment MeanValueinmg% 14.00 13.50 13.00 12.50 12.00 11.50 11.00 F I G U R E - 5 10.50 13.27 11.58 First Natural Insulin Mimetic 4 ( A ) Effect of Naavudi on Serum Cholesterol Effect of Naavudi on Blood Urea
  • 9. First Natural Insulin Mimetic Naavudi TM EffectofNaavudi onSubjectiveSymptoms TM EffectofNaavudi onBodyMassIndex Safety T A B L E - 6 S.No. Symptoms PercentageImproved 1. Polyuria 100 2. Polydipsia 100 3. Increasedappetite 100 4. Weakness 90 5. Fatigue 90 The Post-Prandial Sugar Level which was 243.93 mg% (Before 6. Feelingof coldinhand and feet 100 treatment) was reduced by Naavudi to 164.77 mg% at the end of three 7. Burning sensation 89 months therapy which falls within the normal range. The statistically significantefficacyof thedrugisevidentbyitsPvalue(<0.001).8. Numbness 100 It was observed that, Naavudi has moderately good hypoglycaemic9. Paraesthesia 80 action exhibiting persistent glycaemic control with a slow onset of 10. Muscularpain 100 action thus keeping away the danger of drug induced-hypoglycaemia. It Above table shows that there was marked improvement in subjective is notable that no case of drug induced-hypoglycaemia was observedduringthetrial.symptoms. Besides this, a better sense of well being was observed in all the patients. On the basis of the above results this can be concluded that Thus Naavudi is very much useful in controlling Blood Glucose Level Naavudi can also be used in Insulin Dependent Diabetes Mellitus without any side effects in cases of maturity onset Non-Insulin (IDDM) as an adjuvant which in turn will be helpful in reducing the DependentDiabetesMellitusof mildtomoderateseverity. dosageof Insulinand otherhypoglycaemicdrugs. Marked improvement in symptoms along with a better sense of well Body Mass Index (BMI) is a number calculated by looking at weight inbeing was experienced by all the patients. This may be due to better relation to height and is the most common parameter to define obesityglycaemic control exerted by Naavudi or we may say that these are the whichisamostprevalentriskof DiabetesMellitus.specific Ayurvedic natural constituents of Naavudi which in addition toadequateglycaemiccontrol,inducesabettersenseof wellbeing. PRESENTATION:Stripsof 10capsules. l Naavudi is derived from vegetable and herbal sources and manufactured in a highly scientific manner, hence it is very safe for personsof anyage. l Acute oral toxicity study of Naavudi has been conducted at Institute of Toxicological Research Centre (I.T.R.C.), Lucknow. Dosage (mg/kg) Dead/Dosed Death Signs of Toxicity 5000 0/5 NIL NIL As evident from the Table - 2 & Figure - 2, the mean Body Mass Index (BMI) of the patients was 25.96 indicating that majority of the patients were overweight. Naavudi reduced their BMI up to a mean of 24.88Naavudi at a limit dose of 5000 mg/kg has not produced any signs of indicating a reduction in BMI value towards normal range. P valuepoisoning or death of animals. Autopsy of the surviving animal at the (<0.01) depicts that Naavudi is statistically significant in reducingend of the observation period did not indicate any gross pathological theBMI.changes. As is evident from the Table - 1 & Figure - 1, that the Fasting Blood Sugar Level was reduced by Naavudi from the pre-treatment value of 170.37 mg% to the level of 109.80 mg% at the end of three months therapy. The P value (< 0.001) shows statistically promising significance of thedruginreductionof FastingBloodSugarLevel. T A B L E - 2 Before Treatment After 3 Months Treatment P. Value 25.96 24.88 <0.001Body Mass Index (BMI) F I G U R E - 2 26.50 26.00 25.50 25.00 24.50 24.00 Before Treatment After 3 Months Treatment 25.96 24.88 Effect of Naavudi on Blood Sugar Effect of Naavudi on BMI
  • 10. First Natural Insulin Mimetic Naavudi ClinicalTrialReport Follow-upStudies Observations & Result A clinical trial has been conducted to evaluate the efficacy of Naavudi in the treatment of Non Insulin Dependent Diabetes Mellitus (NIDDM) at Sir Sunder Lal Hospital by Dr. K.N. Devendra, Consultant – Diabetic Clinic (I.M.), Institute of Medical Sciences, Banaras Hindu University, Varanasi. Dr. K.N. Devendra is a member of Diabetic Association of India (DAI), Research Society for Study of Diabetes in India (RSSDI) and Indian Societyof WoundManagement(ISWM). A number of diagnosed patients of Non Insulin Dependent Diabetes Mellitas (NIDDM) were selected for present study from the Out Patient Department (OPD) and In-door of he diabetic clinic, (Indian Medicine), Sir Sunderlal Hospital, Institute of Medical Sciences, Banaras Hindu University,Varanasi. All the patients were examined clinically for the signs and symptoms of Diabetes Mellitus and subjected for routine Bio-chemical investigations asperclinicalprotocol.Self controlmethodwasusedinthisclinicaltrial. All the patients were assessed on clinical and bio-chemical parameters periodically at the interval of one month, two months & threemonths. PARAMETERSOFASSESSMENT Assessmentwasdoneon objectiveand subjectiveparameters. Parametersof Objectiveassessmentwere: ReductioninFastingand Post-PrandialBloodSugarLevel Desirablechangeinthestatusof BodyMassIndex(BMI) ChangesinHaemoglobin Level ChangesinLevelsof SerumCholesterol ChangesinLevelsof BloodUreaand SerumCreatinine Parametersof Subjectiveassessmentwere: Thegentlehypoglycemicactivitybynaturalingredients DOSAGE All the patients were given 1 Naavudi capsule twice daily 30 minutes beforemeals. EFFECTOFNAAVUDIONBLOODGLUCOSELEVEL It was observed that among all the patients who completed 3 months treatment,theBloodGlucoseLevelfellsignificantly. Precautions MulticentrictrialinNIDDMpatients Multicentric trial of NAAVUDI in newly diagnosed NIDDM,withmildtomoderatebloodsugarlevels l Avoid Sweets, Creams, Butter, Cheese, Jams, Pastry & Jellies. l Avoid taking fatty and fried food stuff with excessive spices. l Regular morning walk and mild exercise like yoga helps in effectivecontrolof diabetes. l Bloodsugarlevelsshouldbemonitoredperiodically. Encouraged by the results of clinical evaluation of the beneficial role of NAAVUDI in the management of diabetes in NIDDM patients at IMS, B.H.U, Varanasi, NAAVUDI was offered to many doctors in different cities for first hand evaluation of the novel concept of 'Insulin mimetic effect of naturally found Epicatechin'. Doctors who were looking for a natural alternative to modern OHD available because of long term side effects being observed by them accepted NAAVUDI and tried on their patients who were either new cases not responding to dietary controls and exercises or who were on different OHD, singularly or in mixeddoseregimen.The data receivedbythesedoctorswas statistically analysed which presents a very satisfactory finding that NAAVUDI is quite effective in those cases also where the patients were on modern OHD and ultimately leading to total elimination of the dependence on modern OHD to NAAVUDI which being a naturally derived product is free from any long term side effects and on the contrary patients reported distinctiveimprovementin'qualityof theirlife'. Sixty patients with a mean blood sugar level of 172 mg / dl (fasting) and 264 mg / dl (post prandial) were put on NAAVUDI one capsule b.i.d. half an hour before meals. Fall in blood sugar level was seen from the first month of therapy and at the end of third month blood sugar level came down to normal. None of thepatientshad reportedanysideeffects. Before Treatment After 3 Months Treatment P. Value 1. 170.37 109.80 <0.001 Blood Glucose Level Fasting Blood Sugar (Mean Value in mg%) 2. 243.93 167.77 <0.001 Post-Prandial Blood Sugar (Mean Value in mg%) T A B L E - 1
  • 11. First Natural Insulin Mimetic Naavudi Cis-2 [3-4 dihydroxy-phenyl] 3-4, dihydro-2H-1, benzopyran-3,5,7 triol RoleofHerbalIngredients Physiology & Pharmacology of Active Principles Pterocarpus marsupium : Regenerates cells, mimics insulin, checks blood sugar level. Momordica charantia Linn : Astringent, controls blood sugar level. Cinnamomum tamala : Diuretic, increases blood insulin, stimulates pancreas. Eugenia jambolana : Diuretic, antidiabetic. It diminishes the quantity of sugar in urine; allays the unquenchable thirst. Melia azadirachta : Checks basal metabolism and body sugar level. Picrorrhiza kurrooa : Checks basal metabolism, bitter tonic, corrects the function of liver and kidney. Ocimum sanctum : Diaphoretic, stimulant, anti- stress, adaptogenic. Gymnema sylvestre : Hypoglycemic agent, diuretic, have an oxidase action on glucose solution and shows glycolysis. The whole formulation of Naavudi is based on an active principle 'Epicatechin' which is at the core of the total product. Other ingredients are added to prevent and cure the different complications of diabetes. It controls the metabolicderangementsratherthan merecontrolof blood sugarlevel. Epicatechin the active principle of Naavudi is extracted from the bark of P.marsupiuminahighlyscientificmanner. Epicatechin isabenzopyran havingthefollowingorganicstructure. Thisactiveprinciplecontrolsdiabetesinthefollowingmanner: Epicatechin increases the cAMP content of the islet which is associatedwithincreasedinsulinrelease. Epicatechin plays a role in the conversion of proinsulin to insulin byincreasingcathepsin activity. Epicatechin plays an insulin-mimetic effect on osmotic fragility of human erythrocytes. Epicatechin inhibits Na/K ATPase activity on patient's erythrocytes,an effectsimilartothatof insulin. A B C D OH OH OH OH HO EvaluationofNAAVUDIasadjuvanttoOHD (OralHypoglycaemicDrugs) Observation NAAVUDI was added in the drug-regimen in patients who were not responding to OHD (Pioglitazone, Metformin, Glibenclamide, Gliclazide taken alone or as combination of these drugs). The hypoglycaemic effect of NAAVUDI is established since addition of NAAVUDI with OHD brought down the blood sugar level to normal withtaperingof OHD requirementtoalmosthalf within2months. T A B L E - 9* Dt.ofTesting Treatment TotalDaily BloodSugarLevel Dose mg% Fasting P.P 01.01.2002 Pioglitazone 30mg 30mg Melformin 500mg TDS 1500mg 154 203 25.02.2002 Naavudi 1 BD 2 Caps. Piogitazone 15 mg OD 15 mg Metformin 500mg OD 1000mg 122 178 05.03.2002 Naavudi 1 BD 2 Caps Pioglitazone 15mg OD 15mg Metformin 500mg OD 500mg 95 150 Dr. Prakash Sharma, M.B.B.S New Colony, Pratapgarh-230 001 T A B L E - 10* Dt.ofTesting Treatment TotalDaily BloodSugarLevel Dose mg% Fasting P.P 15.11.2001 Glibenclamide 5 mg BD 10 mg 292 31.12.2001 Glibenclamide 5 mg OD 5 mg Naavudi 1 BD 2 Caps. 201 01.02.2002 Glibenclamide 2.5 mg OD 2.5 mg Naavudi 1 BD 2 Caps. 150 02.03.2002 Glibenclamide Nil Naavudi 1 BD 2 Caps. 126 Dr. Zameer Ahmed, B.Sc.; M.B.B.S Turkmanpur, Gorakhpur-273 005 NAAVUDI has hypoglycaemic effect in NIDDM cases. By adding NAAVUDI to the therapy the dose of oral hypoglycaemic drugs is reduced or the same can be discontinued depending upon individual patient.
  • 12. First Natural Insulin Mimetic Naavudi StandardizationofHerbalFormulation Formulation Naavudi has been standardized in terms of "Epicatechin", an active principleof thisformulation. The first step adopted towards attaining quality and consistency is the strict adherence to the rigorous standardized procedure that are followed in the collection of Pterocarpus marsupium. Proper identification and selection of the herb, proper time of the year for harvest, proper maturity of the bark of the plant used are the three most important specifications set, that are used for the collection and standardizationof alltheherbsused. After proper selection of the herbs, each and every herb is subjected to the rigid standards like assessment of foreign organic matter, water soluble extractive, ethanol soluble extractive, moisture content, microbial contamination and chromatographic finger printing. After proper quality assessment of each and every ingredient, they have to undergo processing. Processing of the herb and active ingredient involve proprietary know-how. In Naavudi the active ingredient has been extracted, processed concentrated by a unique technique so that the goodness of whole constituent is incorporated in onecapsule. After successfully developing the combination (formulation), Naavudi was standardized in terms of moisture content, total extractable component, foreign organic and inorganic impurities, total microbial load, active principle 'Epicatechin'; distintegration time, weight variation of the capsule etc.. To make the consistency of the formulation (which is the major problem in herbal formulation) 'finger printing' of the formulation has been developed in terms of specific marker, which is the 'key' of the formulation. Apart from this, the formulation has also been tested in terms of its 'efficacy' under different stressedconditions. Institute of Toxicological Research Centre, Lucknow for acute toxicity studiesand hasbeenfoundtotallyfreefromanysideeffects. Naavudi capsule has been scientifically formulated to create a better, balanced,complementaryand non toxicmedicine. Composition Proprietary Blend across Composition Doctor's Observations on NAAVUDI in Diabetes Mellitus "It does not increase weight rather it decreases B.M.I. It decreases significantly PPBS in type II Diabetes Mellitus. It decreases the requirement of O.H.Ds / Insulin if usedincombination." — Dr. Chakrapani Pandey, M.D., F.C.C.P. 1, M.P. Building Golghar Gorakhpur "The response of NAAVUDI on the patients is satisfactory. During treatment therewasnohypoglycemiaoranyothercomplication." — Dr. Chakrapani Pandey, M.D., F.C.C.P. 1, M.P. Building Golghar Gorakhpur "My blood sugar fasting before NAAVUDI (treatment) was 265 mg %. After one monthbloodsugarwas180mg%.Now bloodsugarisnormal." — Dr. Z.A. Noor, B.M.S. Dhampur Road, Nehtaur, Distt. Bijnore "I tried NAAVUDI capsules on my mother. She was taking glybenclamide 5 mg. OD and metformin 500 mg BID half an hour before meals. She is normal from 1st day(of treatmentwithNAAVUDI)and physicallyfit." — Dr. Fahimuddin Ansari, B.Sc.; B.A.M.S. Raja Ka Tajpur, Distt. Bijnore 246735
  • 13. Preface Diabetes Mellitus (DM) represents a major medical problem affecting millions of people all over the world. Diabetes is a metabolic disorder in which the body does not produce or properly use insulin, a hormone responsible for converting sugar,starchandfatsintoenergyneededfordailylife. The two distinct forms of DM are, Type I, juvenile or Insulin Dependent Diabetes Mellitus (IDDM – an auto immune disease in which body does not produce any insulin) andType II, adult onset or Non Insulin Dependent Diabetes Mellitus (NIDDM – a metabolic disorder resulting from the body's inabilitytomakesufficientorproperlyuseinsulin). However, since there are more adult onset cases (NIDDM–90–95%) than juvenile ones (IDDM-5-10%); TypeIIneedsmoreattention. Despite a significant improvement over the past two decades in our understanding and treatment of Diabetes Mellitus many aspects about the subject need to be elucidated, because the management and treatment of Diabetes Mellitus still remains one of the major challenges for the medical profession. Looking at the inconveniences and agony of persons suffering from diabetes and trying out various medicaments, developing diabetic neuropathy, increasing renal load and various other complications like haematological disorders, cardiovascular complications, weight loss, lactic acidosis and retinopathy etc., the Research and Development team of Naavudi started workingonherbalremedyfordiabetes. On a prolonged study it was found that 'Epicatechin' which is found in abundance naturally in wood commonly known as Vijaysar, (Pterocarpus marsupium) mimics insulin in its action. Encouraged by the finding, the team continued to work on developing a combination of herbs and natural products which would be synergistically beneficial to a diabetic patient as a whole. The objective was not only to take care of blood glucose level but also to take care of other peripheral problems associated with it, which cause major distresstothepatient. Bibliography and References 1. Ahmed et al, 1991, Indian Journal of Experimental Biology 24,516-520. 2. AnsorgeS,etal,Acta.Biol.Med.Germ.36(1997),1723. 3. BansalRetal,ActaDiabetol,17(1980)255. 4. Rizvietal,(1995)IndianJournalofExperimentalBiology33. 5. Rizvietal,(1998)MedicalScienceResearch26,245-249.
  • 14. NaavudiFIRST NATURAL INSULIN-MIMETIC Information Booklet Information Booklet I N P U R S U I T O F H E A L T H I E R M A N K I N D Commodity Link Enterprises (CLE) Naavudi Health Blood Sugar Support Visit us at www.Naavudi.com

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