Role of Phaltrikadi Kwath, Chandraprabha Vati and Nyogradhadi Churn in Type-II Diabetes
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2021/07/034550
- Lead Sponsor
- Government Post Graduate Ayurveda College and Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Patients of either sex aged between 30 to 65 years
2. Treatment naive patients or diagnosed patients of Type II Diabetes Mellitus taking oral
hypoglycaemic drugs for <= 6 weeks
3. Patients having Glycosylated haemoglobin (HbA1c) >= 6.5%.
4. Willing and able to participate for 16 weeks
1. Patients already diagnosed to be suffering from the complications of Diabetes Mellitus
viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy, etc.
2. Patients suffering from 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. Patient with poorly controlled Hypertension ( > 160 / 100 mm Hg)
5. Symptomatic patient with clinical evidence of Heart failure.
6. 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.
7. Pregnant / Lactating women.
8. Patient on steroids, oral contraceptive pills or oestrogen replacement therapy.
9. Alcoholics and/or drug abusers.
10. Patients with evidence of malignancy
11. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)
12. H/o hypersensitivity to any of the trial drugs or their ingredients.
13. Patients who have completed participation in any other clinical trial during the past six
(06) months.
14. Any other condition which the P.I. thinks may jeopardize the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Glycosylated haemoglobin (HbA1c %)Timepoint: 42 days
- Secondary Outcome Measures
Name Time Method Change in Symptoms -Diabetes Symptoms Questionnaire (DSQ) <br/ ><br>Change in Blood sugar Fasting. (10-12 hrs after dinner) <br/ ><br>Change in Blood sugar Post -Prandial (100-120 minutes after breakfast) <br/ ><br>Change in the SF-36-Health Survey Score.Timepoint: 12 weeks