This is a Clinical Trial that will compare the antidiabetic effect of combination of Ayurvedic drug AYUSH D and metformin with only Metformin in Type 2-Diabetes Mellitus subjects.
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2017/11/010711
- Lead Sponsor
- Incharge
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients of either sex aged between 18 to 70 years.
2.Diagnosed patient of Type 2 Diabetes having Glycosylated Haemoglobin (HbA1c) between 7% - 9%
3.Willing to participate and able to provide signed informed consent.
1.Subject of type 1 DM or type 2 DM on insulin/OHAâ??s other than metformin/any other AYUSH medication for glucose control.
2.Subjects suffering from the complications of Diabetes Mellitus viz., diabetic neuropathy, nephropathy, retinopathy, etc. which require an urgent treatment.
3.Subjects with uncontrolled hypertension (with or without medication >140/90mmHg after 5 mins of rest)
4.Subjects with established diagnosis of CAD requiring any procedure in next 6 months â?? angioplasty on bypass surgery or subjects with New York Heart Association (NYHA) Classification Category III and IV cardiac insufficiency, or any other clinically significant cardiovascular disease.
5.Subjects with concurrent Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > greater than ULL),uncontrolled Pulmonary Dysfunction (asthmatic and COPD subjects)
6.Female subject of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy.
7.Pregnant / Lactating women.
8.Subject on systemic or oral steroids, oral contraceptive pills or estrogens replacement therapy.
9.Subjects who have a recent history or who are currently known to abuse alcohol or drugs.
10.Subjects with current or past diagnosis of malignancy (any malignancy diagnosis in last five years).
11.Subjects suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)
12.Subjects who have completed participation in any other clinical trial during the past three months.
Any other condition which the Investigator thinks may jeopardize the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method