Clinical trial on Madhumeha (Type-2 Diabetes mellitus) with Mamajjaka ghanavati
- Conditions
- Diabetics aged between 35 to 65 years.
- Registration Number
- CTRI/2017/09/009887
- Lead Sponsor
- Central Council of Research in Ayurvedic Sciences
- Brief Summary
Diabetes mellitus (DM) is the third killer of themankind and it is one of the most challenging diseases facing health careprofessionals today1. It is comparable to *Madhumeha2*.Conventional agents are being used to control diabetes along with lifestyle management.To date, over 400traditional plant treatments for diabetes have been reported, although only asmall number of these have received scientific and medical evaluation to assesstheir efficacy. The hypoglycemic effect of some herbal extracts has beenconfirmed in human and animal models of type-2 diabetes. The World Health Organization Expert Committee ondiabetes has recommended that traditional medicinal herbs be furtherinvestigated 3. Ayurvedic drugs not only have *Pramehagna*(antidiabetic),but also have *Rasayana* (Immunomodulator) properties. This clinical trialfocuses on the validation of the safety& efficacy of the Ayurvedic formulation Mamajjaka ghanavati .
The drug *Mamajjaka ghanavati* contains *Mamajjaka* (Enicostemma littorale) extract-8 parts, 2 parts each of *Mamajjaka*(Enicostemma littorale) Churna , *Katuki* (Picrorrhiza kurroa ) *Pippali* (Piper longum ) and *Ativisha*(Aconitum heterophyllum). *Mamajjaka* (Enicostemma littorale) ismentioned in Shodhala Nighantu (12thcentury) in Lakshmanadi varga 4. *Mamajjaka*(Enicostemma littorale) has antidiabetic5 and antioxidant properties6*.* Shukla & Shukla concludedthat E*. littorale* extract for 45 days significantly reducedhyperglycemia in type 2 diabetes mellitus. *Enicostemma littorale* possess potential antidiabeticactivity and improves lipid profile at a small dose of 0.5 g/kg7.
*Ativisha*(Aconitum heterophyllum) is one of thebitter constituents, which is described in Ayurveda, as an effective drug innoninsulin dependant Diabetes8. Ethanolic extract of Piper longum(PLEFet) hasshown significantanti hyperglycemic, anti lipid peroxidativeand antioxidant effects in diabetic rats. It has also corrected the metabolicalterations observed by the activities of several carbohydrate metabolizingenzymes. The anti hyperglycemic effect of PLEFethas been comparedto that of the standard reference drug glibenclamide 9. *Katuki* (Picrorhiza kurroa) has been stated to be apromising strategy for the treatment of diabetic nephropathy10.*Picrorhiza kurroa is* hepatoprotective, antioxidant and hypolipidemicdrug 11. The current clinicaltrial focuses on Ayurvedic drug preparation used in the treatment of diabetesmellitus, a major non-communicable disease leading to huge economic losses.
Bibliography
1. [Qi LW](https://www.ncbi.nlm.nih.gov/pubmed/?term=Qi%20LW%5BAuthor%5D&cauthor=true&cauthor_uid=20180758)et al. Anti-diabetic agents from natural products--an update from 2004 to 2009.[Curr Top Med Chem.](https://www.ncbi.nlm.nih.gov/pubmed/20180758 "Current topics in medicinal chemistry.") 2010;10(4):434-57.
2. Clinical Research Protocols forTraditional Health sciences, Central Council of Research in Ayurvedic Sciences,Dept of AYUSH, Govt of India, New Delhi 2010, pg 459.
3. [Manisha Modak](https://www.ncbi.nlm.nih.gov/pubmed/?term=Modak%20M%5BAuthor%5D&cauthor=true&cauthor_uid=18398493) et al IndianHerbs and Herbal Drugs Used for the Treatment of Diabetes [J Clin Biochem Nutr](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2275761/). 2007 May; 40(3): 163–173.
4. PV Sharma.(ed). Sodala Nighantu of Vaidyachary Sodala, 1st ed.Baroda: Oriental institute; 1978.,Lakshmanadi varga.
5. [Vijayvargia R](http://www.ncbi.nlm.nih.gov/pubmed/?term=Vijayvargia%20R%5BAuthor%5D&cauthor=true&cauthor_uid=12557910)et al, Hypoglycemic effect of aqueous extract of Enicostemma littorale Blume(chhota chirayata) on alloxan induced diabetes mellitus in rats. [Indian J Exp Biol.](http://www.ncbi.nlm.nih.gov/pubmed/12557910 "Indian journal of experimental biology.") 2000Aug; 38(8):781-4.
6. RajamaniSaranya et al, Pharmacognosy ofEnicostemma littorale: A review, Asian Pacific Journal of Tropical Biomedicine,Asian Pac J Trop Biomed 2013; 3(1): 79-84
7. ShuklaAmarnath, Shukla HM. Single blind placebo controlled clinical evaluation of
Mamajjaka ghanvati in prameha with specialreference to diabetes mellitus. Journal of
Ayurveda and Holistic Medicine, 2013; 1(5): 11-9.
8. M.D.Ukani, N.K Mehta and D.D Nanavati, Aconitum Heterophyllum (Ativisha) InAyurveda, Ancient Science of life Vol. No XVI 2 Oct 1996, Page 166 -171
9. [Shanmugam Manoharan](http://ascidatabase.com/author.php?author=Shanmugam&last=Manoharan "Click to find out more papers by Shanmugam Manoharan"), et al, Antihyperglycemic and Antilipid peroxidativeeffects of Piper longum (Linn.) driedfruits in Alloxan Induced Diabetic rat, Journal of Biological sciences6(1):161-168, 2007.
10. [Akihiro Tojo](http://www.tandfonline.com/author/Tojo%2C+Akihiro) et al, Suppressing renal NADPH oxidase to treat diabetic nephropathy, Expert Opinion on Therapeutic Targets ,[Volume 11](http://www.tandfonline.com/loi/iett20?open=11#vol_11), [Issue 8](http://www.tandfonline.com/toc/iett20/11/8), 2007
11. RangasamyAnandan, Preventive Effects of Picrorhiza kurroa on D-Galactosamine-InducedHepatitis in Rats, Journal of Clinical Biochemistry and Nutrition ,[Vol. 25](https://www.jstage.jst.go.jp/AF06S010SryTopHyj?sryCd=jcbn&noVol=25&noIssue=)(1998) [No. 2](https://www.jstage.jst.go.jp/AF06S010SryTopHyj?sryCd=jcbn&noVol=25&noIssue=2)P87-95
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
- 1.Diabetics aged between 35 to 65 years. 2.Patients who are diagnosed to be Type II Diabetics by having Glycosylated Haemoglobin (HbA1c) between 6.5%.
- 9% or BS-F between 126 mg%.
- 200 mg% or BS-PP / Random between 200 mg%.
- 250 mg%. 3. Willing to participate and able to provide signed informed consent.
- Patients suffering from the complications of Diabetes Mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy, etc.
- Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- 3.Hypertensive patients (> 140 / 90 mm Hg).
- Symptomatic patient with clinical evidence of Heart failure.
- 4.Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S.
- creatinine > 1.2 mg/dl),uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.
- Pregnant / Lactating women.
- Patient on steroids, oral contraceptive pills or estrogens replacement therapy.
- Alcoholics and/or drug abusers.
- 8.Patients with evidence of malignancy 9.Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.) 10.H/o hypersensitivity to any of the trial drugs or their ingredients.
- 11.Patients who have completed participation in any other clinical trial during the past six (06) months.
- 12.Any other condition which the Investigator thinks may jeopardize the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Glycosylated haemoglobin (HbA1c%) 0 day(Baseline) and 84th day
- Secondary Outcome Measures
Name Time Method 1.Change in Blood sugar Fasting (10-12 hrs after dinner) and Post - Prandial. (100-120 minutes after breakfast) 2.Change in Symptoms -Diabetes Symptoms Questionnaire (DSQ)
Trial Locations
- Locations (3)
National research Institute of Ayurveda Drug Development (NRIADD),
🇮🇳Khordha, ORISSA, India
National Veterinary Ayurveda Research Institute & Hospital
🇮🇳Barabanki, UTTAR PRADESH, India
Regional Ayurveda Research Institute for Metabolic disorders
🇮🇳Bangalore, KARNATAKA, India
National research Institute of Ayurveda Drug Development (NRIADD),🇮🇳Khordha, ORISSA, IndiaDrBikartan DasPrincipal investigator9438731606dasbikartan@gmail.com