To evaluate the efficacy of Ayurvedic Sugar-free drink for the Type 2 Diabetic Patients & prediabetics and Improving Quality of Life.

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 - NA

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/092692

Enrollment

Registered

2025-08-08

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1) 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. 2) 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. 3) Subjects with Body Mass Index (BMI) more than 27 kgper m2 and less than 45 kgperm2. 4) Women of childbearing potential must be willing to use double-barrier contraception for the entire study.

Exclusion criteria

Exclusion criteria: 1) Women with regular menstruation history having missed periods. 2) Confirmed cases of pregnancy and lactation. 3) Patients who are on insulin therapy. 4) Patients with a history of chronic illness type 1 diabetes and /or history of ketoacidosis. 5) Patients with Insulin use and or or hyperosmolar hyperglycaemic state 6) Patients with secondary diabetes (including disease of the exocrine pancreas, endocrinopathies). 7) Any condition of the patient which may have an impact on the objective and outcome of the trial example: patients currently undergoing major/minor surgical procedures.

Design outcomes

Primary

Measure	Time frame
To evaluate changes in the diabetic panel, i.e., random blood sugar, glycosylated haemoglobin (HbA1C), fasting blood sugar.Timepoint: At visit 1 (screening & baseline), visit 2 (at week 4), visit 3 (at week 8), visit 4 (at week 12)	—

Secondary

Measure	Time frame
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.Timepoint: visit 1, 2, 3 and 4	—

Countries

India

Contacts

Public ContactDr Baidyanath Mishra

Dabur India Limited

baidyanath.mishra@dabur.com911203378606

Outcome results