CTRI/2022/09/046014
Not yet recruiting
Phase 4
A Comparative Clinical Trial On The Efficacy Of Vidangadi Loha And Phalatrikadi Ghanavati With And Without The Prior Administration Of Virechana Karma In Madhumeha (Obese Diabetic).
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Sponsor
- ALL INDIA INSTITUTE OF AYURVEDA
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patients of either gender in the age group of 30\-60 years.
- •2\.Patients with classical signs and symptoms of Madhumeha.
- •3\.Patients giving the clinical history of Obese Diabetic (DM Type II).
- •4\.Patients with random blood sugar level (RBS) \>200 mg/dl up to 350 mg/dl
- •5\.Fasting blood sugar (FBS) \>126 mg/dl up to 250 mg/dl
- •6\.Postprandial blood sugar (PPBS) \>140 mg/dl up to 350 mg/dl
- •7\.Glycosylated haemoglobin \> 7\.5% up to 15%
- •NOTE (In the above\-given criteria, there is one should be present and raised HbA1C is necessary.)
- •8\.Sthula Pramehi (Overweight / Obese \- BMI \>25 g/m2\)
- •9\.Newly /early diagnosed cases to be included as per following criteria:
Exclusion Criteria
- •1\.Patients having insulin dependent DM (type 1\) and receiving insulin / OHA
- •2\.Excessive blood glucose: FBS \> 250 mg/dl, PPBS \> 350 mg/dl, RBS \>350 mg/dl and HbA1c \>15%
- •3\.Emergency conditions in cases of DM.
- •4\.Patients with acute/chronic liver disease with elevated liver enzymes.
- •5\.Chronic complications like microvascular and macrovascular derangements.
- •6\.Patients reporting to be hypersensitive to any of the proposed trial drugs.
- •7\.Pregnant women/ lactating mothers
- •8\.Participation in other clinical studies in past 12 weeks.
- •9\.Takes psychotropic medications that raise blood glucose (e.g. atypical antipsychotics)
Outcomes
Primary Outcomes
Not specified
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