An Open label, Single arm, clinical Study to evaluate efficacy of Ayurvedic Sugar-free drink for the Type 2 Diabetic Patients & prediabetics and Improving QOL
Overview
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Dabur India Limited
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- To evaluate changes in the diabetic panel, i.e., random blood sugar, glycosylated haemoglobin (HbA1C), fasting blood sugar.
Overview
Brief Summary
An Open label, Single arm, clinical Study to evaluate efficacy of Ayurvedic Sugar-free drink for the Type 2 Diabetic Patients & prediabetics and Improving QOL. The objective of current study is to evaluate the efficacy of Ayurvedic Sugar-free drink for the Type 2 Diabetic Patients & prediabetics and Improving Quality of Life.Participants as below will be recruited in 1:2 ratio: Prediabetics (borderline) and Confirmed diabetics cases concomitantly taking Oral Hypoglycaemic Drugs. Primary outcome will beTo evaluate changes in the diabetic panel, i.e., random blood sugar, glycosylated haemoglobin (HbA1C), fasting blood sugar. Secondary outcome will be To evaluate if there is reduction in Body mass index (BMI) and any notable changes in haematology and biochemistry profile leading to improvement in quality of life.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Subjects aged more than 18 years of age who agree to participate in the study willing and able to answer the questionnaire and give their written informed consent.
- •For Diabetics-Participant with initial HBA1c value 6.5percent and above.
- •Patients who are under the treatment of oral antidiabetic drugs.
- •Patients who have not changed their medication in the last three months prior to signing up for the study.
- •(However, dosage modifications are allowed).
- •For prediabetics: Participant with initial HBA1c value 5.7 to 6.4 percent.3) Known cases of pre-diabetes with fasting blood sugar not exceeding 130mg/dl with obesity and having family history of diabetes.
- •Subjects with Body Mass Index (BMI) more than 27 kgper m2 and less than 45 kgperm2.
Exclusion Criteria
- •Women with regular menstruation history having missed periods.
- •Confirmed cases of pregnancy and lactation.
- •Patients who are on insulin therapy.
- •Patients with a history of chronic illness type 1 diabetes and /or history of ketoacidosis.
- •Patients with Insulin use and or or hyperosmolar hyperglycaemic state 6) Patients with secondary diabetes (including disease of the exocrine pancreas, endocrinopathies).
Outcomes
Primary Outcomes
To evaluate changes in the diabetic panel, i.e., random blood sugar, glycosylated haemoglobin (HbA1C), fasting blood sugar.
Time Frame: At visit 1 (screening & baseline), visit 2 (at week 4), visit 3 (at week 8), visit 4 (at week 12)
Secondary Outcomes
- To evaluate if there is reduction in Body mass index (BMI) and any notable changes in haematology and biochemistry profile leading to improvement in quality of life.(visit 1, 2, 3 and 4)
Investigators
Srinivasa Yathapu Reddy
Dabur India Limited