Clinical Evaluation of Saptavimshatika Guggulu and Haridra Churna in the Management of Type II Diabetes Mellitus.
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 3
- Primary Endpoint
- • Change in Glycosylated haemoglobin (HbA1c%)
Study Overview
Brief Summary
Aimed at scientific validation of the clinical efficacy and safety of twenty nine (29) classical Ayurvedic pharmacopoeial formulations, multicentre clinical trials have been initiated as an activity under the Ayurveda Clinical Trials (ACT) project of the Ayurvedic Pharmacopoeia Committee (APC) during August 2010 in eighteen (18) disease conditions involving fifty four (54) M.D/PhD (Ay.) research scholars in eight (08) postgraduate Ayurveda colleges across the country.
Saptavimshatika Guggulu is a poly herbal preparation containing Sunthi (Zingiber officinale), Marica (Piper nigrum), Pippali (Piper longum), Haritaki (Terminalia chebula), Bibhitaka (Terminalia belerica), Amlaki (Emblica officinalis), kustha (Saussurea lappa), Vidanga (Embelia ribes), Guduci (Tinospora cordifolia), Citraka (Plumbago zeylanica), Sati (Hedychium spicatum), Sukshma ela (Elettaria cardamomum), Pippali mula (Piper longum), Hapusa (Juniperus communis), Devdaru (Cedrus deodara), Tejovati (Zanthoxylum aromaticum), Puskara (Saussurea lappa), Cavya (Piper chaba), Rakta indravaruni (Citrullus colocynthis), Haridra (Curcuma longa), Daruharidra (Berberis aristata), Vid lavana, Saurvanchala lavana, Saindhava lavana, Yava kshara, Sarji kshara, Gaja pippali (Scindapsus officinalis) and Guggulu (Commiphora wightii).
Haridra Churna is prepared by air drying the rhizomes of Haldi (Curcuma longa).
The present study is being undertaken in three post graduate Ayurveda colleges involving the post graduate scholars who are doing the clinical trials to scientifically study and validate the clinical efficacy and safety of Saptavimshatika Guggulu and Haridra Churna- the classical Ayurvedic formulation which have been in use since ages and found to be useful in treating Type II Diabetes Mellitus and promoting the health.
The Central Council for Research in Ayurvedic Sciences (CCRAS) is the nodal organization to co-ordinate and monitor these trials. CCRAS has provided the necessary infrastructure to the participating colleges, technical inputs (including the clinical trial protocols), trial drugs and training to the researchers involved in the project.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 30.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of either sex aged between 30 to 65 years
- •Treatment naive patients or diagnosed patients of Type II Diabetes Mellitus taking oral hypoglycemic drugs for ≤ 6 weeks
- •Patients having Glycosylated haemoglobin (HbA1c) ≥ 6.5%.
- •Willing and able to participate for 16 weeks.
Exclusion Criteria
- •Patients already diagnosed to be suffering from the complications of Diabetes Mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy, etc.
- •Patients suffering from brittle diabetes mellitus.
- •Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- •Patient with poorly controlled Hypertension ( > 160 / 100 mm Hg)
- •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 estrogen replacement therapy.
- •Alcoholics and/or drug abusers.
- •Patients with evidence of malignancy
- •H/o hypersensitivity to any of the trial drugs or their ingredients.
- •Patients who have completed participation in any other clinical trial during the past six (06) months.
- •Any other condition which the P.I. thinks may jeopardize the study.
Outcomes
Primary Outcomes
• Change in Glycosylated haemoglobin (HbA1c%)
Time Frame: At Baseline, on 42nd day and on 84th day.
Secondary Outcomes
- • Change in Symptoms -Diabetes Symptoms Questionnaire (DSQ)(• Change in Blood sugar Fasting. (10-12 hrs after dinner))