A clinical study to see the effect of some Ayurvedic formulations in the patients of Type II Diabetes Mellitus.

Phase 2

• Conditions: Health Condition 1: null- Type-II Diabetese Mellitus

• Registration Number: CTRI/2014/05/004613
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences CCRAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

1. Patients who are diagnosed to be Type II Diabetics by either HbA1c >6.5%. or BS-F >126 mg% of BS-PP >200 mg% / Diabetics who are on lifestyle modification & /or on Tab.Metformin upto 2gm/ day.

2. Willing to participate in clinical trial.

Exclusion Criteria

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 Type-I / 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 ( >140 / 90 mm Hg).

5. Patient with poorly controlled Gycemic 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 > 1.2mg/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 estrogen 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. 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
Change in Blood Sugar Fasting(10-12 hours after dinner)Timepoint: Change in Blood Sugar Fasting(10-12 hours after dinner)

Secondary Outcome Measures

Name	Time	Method
Change in Blood sugar Post -Prandial. (100-120 <br/ ><br>minutes after breakfast)Timepoint: At Baseline, 14th day-28th day-42nd day-56th <br/ ><br>day-70th day-84th day and at the end of follow <br/ ><br>up on 98th Day;Change in Glycosylated haemoglobin (HbA1c%)Timepoint: At Baseline and 84th day;Change in Symptoms -Diabetes Symptoms Questionnaire (DSQ)Timepoint: At Baseline-84th day and at the end of follow up <br/ ><br>on 98th Day;Change in the SF-36-Health Survey ScoreTimepoint: At Baseline,at 84th day and at the end of follow <br/ ><br>up on 98th Day