Clinical evaluation of Mamajjaka ghanavati in the management of Madhumeha(Type II Diabetes mellitus)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Change in Glycosylated haemoglobin (HbA1c%)
研究概览
简要总结
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 LWet al. Anti-diabetic agents from natural products--an update from 2004 to 2009.Curr Top Med Chem. 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 et al IndianHerbs and Herbal Drugs Used for the Treatment of Diabetes J Clin Biochem Nutr. 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 Ret al, Hypoglycemic effect of aqueous extract of Enicostemma littorale Blume(chhota chirayata) on alloxan induced diabetes mellitus in rats. Indian J Exp Biol. 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, 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 et al, Suppressing renal NADPH oxidase to treat diabetic nephropathy, Expert Opinion on Therapeutic Targets ,Volume 11, Issue 8, 2007
11. RangasamyAnandan, Preventive Effects of Picrorhiza kurroa on D-Galactosamine-InducedHepatitis in Rats, Journal of Clinical Biochemistry and Nutrition ,Vol. 25(1998) No. 2P87-95
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 35.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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%.
- •Willing to participate and able to provide signed informed consent.
排除标准
- •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.
结局指标
主要结局
Change in Glycosylated haemoglobin (HbA1c%)
时间窗: 0 day(Baseline) and 84th day
次要结局
- 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))