CTRI/2014/09/005048Not yet recruitingPhase 2
CLINICAL EVALUATION OF GOKSHURADI GUGGULU AND GUDUCHI CHURNA IN THE MANAGEMENT OF TYPE II DIABETES MELLITUS (MADHUMEHA)
Central Council for Research in Ayurvedic sciences CCRAS1 site in 1 country58 target enrollmentStarted: January 10, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Change in Glycosylated haemoglobin (HbA1c%)
Study Overview
Brief Summary
The present clinical trial is being done to scientifically validate the clinical safety and efficacy of a combination of the classical Ayurvedic formulations- Gokshuradi Guggulu and Guduchyadi Churna. The Gokshuradi Guggulu is a polyherbal formulation comprising of Tribulus terrestris, Commiphora wightii, Zingiber officinale, Piper nigrum, Piper longum, Terminalia chebula, Terminalia belerica, Emblica officinalis and Cyperus rotundus whereas, Guduchyadi churna primarily comprises of Tinospora cordifolia. The effect of this combination on the identified objective as well as subjective parameters along with overall Quality of Life will be evaluated in patients suffering from Type II Diabetes Mellitus.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
Eligibility Criteria
- Ages
- 30.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Diabetics aged between 30 to 60 years.
- •2.The freshly diagnosed and naive (those who are not taking any Oral Hypoglycaemic Agent.)
- •Patients who are diagnosed to be Type 2 Diabetics by either having Glycosylated haemoglobin (HbA1c) ≥ 6.5% or BS-F > 126 mg% or BS-PP >200 mg%.
- •4.Willing to participate.
Exclusion Criteria
- •1.Patients already diagnosed to be suffering from the complications of Diabetes Mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy, etc.
- •Patients suffering from Type I Diabetes Mellitus or Brittle Diabetes Mellitus.
- •3.Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- •4.Hypertensive patients (> 140 / 90 mm Hg).
- •5.Patients with poorly controlled Glycaemic status (HbA1c>8%).
- •6.Symptomatic patient with clinical evidence of Heart failure.
- •7.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.
- •8.Pregnant / Lactating women.
- •9.Patient on steroids, oral contraceptive pills or estrogens replacement therapy.
- •10.Alcoholics and/or drug abusers.
- •11.Patients with evidence of malignancy 12.Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.) 13.H/o hypersensitivity to any of the trial drugs or their ingredients.
- •14.Patients who have completed participation in any other clinical trial during the past six (06) months 15.Patients with Microvascular and other complications of Diabetes Mellitus.
- •16..The patients suffering from Brittle Diabetes.
- •17.Any other condition which the Investigator thinks may jeopardize the study.
Outcomes
Primary Outcomes
Change in Glycosylated haemoglobin (HbA1c%)
Time Frame: At screening and at the end of 12 weeks of treatment.
Secondary Outcomes
- •Change in Blood sugar Fasting. (10-12 hrs after dinner)(•Change in Symptoms -Diabetes Symptoms Questionnaire (DSQ))
Investigators
Study Sites (1)
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