A clinical study of DIADROPSZ, an ayurvedic product in treatment of Type 2 Diabetes Melitus
- Conditions
- Health Condition 1: null- Patients with Type 2 Diabetes Melitus who are drug naive and on adjuant medicationHealth Condition 2: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2017/03/008057
- Lead Sponsor
- Clinfound Clinical Research Services PvtLtd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 50
1.Body mass index (BMI) below 40 kg/m².
Group A
1.25 Drug naive or previously treated Type 2 DM or patients willing to shift to sole Ayurvedic treatment.
2.Hemoglobin A1c (HbA1c) >=7.5% and <=11% or
3.Fasting Plasma Glucose (FPG) >=130 mg/dL
Group B.
1.25 patients with Type 2 DM with Modern Pharmaceutical Medication having insufficient glucose control.
2.Insufficient glucose control defined as laboratory results that are within the values established by the study such as an Hemoglobin A1c (HbA1c) >=7.5% and <=11% or a Fasting Plasma Glucose (FPG) >=130 mg/dL
1.Type 1 diabetes.
2.Current need for Insulin treatment.
3.Complication of DM.
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 > 1.6mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.
5.Women who are pregnant or lactating
6.Smokers/Alcoholics and/or drug abusers
7. Patient with poorly controlled Hypertension
8. Patients with evidence of malignancy
9. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method