Safety and efficacy study of Chyawanprash on Blood Glucose Levels in Patients with Controlled Type II Diabetes Mellitus.

Not Applicable

Completed

• Conditions: Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications

• Registration Number: CTRI/2019/11/022172
• Lead Sponsor: Patanjali Ayurved Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-12-27
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

1 Age 35 to 65 yrs

2 Subjects having Fasting Blood Glucose level from 90-150 mg/dL (both inclusive)

3 Subjects having current Doctorâ??s note for confirmation of Type II Diabetes Mellitus and willing to let a copy of the Doctorâ??s note be maintained with the study data

4 Subjects with history of stable weight, defined as no significant weight change (less than ±5%) within 03 months prior to enrollment

5 Patients who have taken only Metformin 500 mg twice daily, and no other oral hypoglycemic agent, for at least 3 months prior to the screening visit

6 If any patient is on anti-hypertensive therapy, lipid-lowering agents, or thyroid medications, the dosage must be constant for at least 2 months prior to the screening visit

7 Subjects willing to give a written informed consent for their voluntary participation in the study

8 Subjects willing to abide by the study requirements and visit the site as per study schedule

Exclusion Criteria

1 Subjects having Type 1 Diabetes Mellitus

2 Currently taking or is required to take any herbal products and dietary supplements, during the past 3 months

3 Diagnosed with an eating disorder such as bulimia or binge eating

4 Any acute gastrointestinal disease within 2 weeks prior to study entry

5 History of Cancer

6 Clinically significant cardiac disease or endocrine abnormalities other than stable thyroid disorders

7 History of Bariatric surgery

8 Participation in a clinical study within the previous 30 days

9 Any relevant surgical treatment during the previous two months or planned during the study

10 Subjects on any prescription medications that might interfere with the study outcome

11 Known history of positive HIV

12 Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified