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EFFICACY OF BERBERINE ON GLYCAEMIC CONTROL IN PREDIABETIC INDIVIDUAL

Double Blinded, Randomised, and Placebo Controlled Trial to evaluate the efficacy of the product on markers of glycaemic control in otherwise healthy prediabetic individuals

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038751
Enrollment
34
Registered
2021-12-20
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

None listed

Interventions

None listed

Sponsors

ANTARMAYEE PANIGRAHI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. fulfilling prediabetic diagnostic criteria (taken within 12 weeks) 2. Agree to continue current diet and refrain from any new supplements 3. Able to read and understand English 4. Informed consent to the trial 5. Willingness to complete the Performa, drug diary and records associated with the study and cooperate for follow up calls and visits

Exclusion criteria

Exclusion criteria: 1. Pregnant /lactating women / women planning for pregnancy in next 12 weeks 2. Transgender or individual on hormonal injection 3. Individual with co-morbidities like malnourishment, impaired hepatic and renal function, cardiac diseases, any acute/ severe diseases /undergone bariatric surgery 4. Currently on weight loss medications, any oral hypoglycaemic medication or insulin injection / steroids 5. Current daily use of herbal / non-herbal supplements 6. Current daily tobacco smoker /chewer / substance abuse • Known allergies to the any substances of the product

Design outcomes

Primary

MeasureTime frame
1.Fasting Blood Glucose 2.Fasting Insulin 3.2hr Oral Glucose Tolerance Test 4. Glycated Hemoglobin A1c 5. Homeostatic Model Assessment For Insulin Resistance (HOMA-IR) Timepoint: 1. 1st follow-up: Day 28 ± 2 2. 2nd follow-up: Day 56 ± 2 3. End of the study visit: Day 84± 2

Secondary

MeasureTime frame
1.Lipid profile : Total Cholesterol, Low Density Lipoprotein , High Density Lipoprotein 2.Body weight and waist circumference 3.BMI Timepoint: 1. 1st follow-up: Day 28 ± 2 2. 2nd follow-up: Day 56 ± 2 3. End of the study visit: Day 84± 2

Countries

India

Contacts

Public ContactDR ANTARMAYEE PANIGRAHI

SIKSHAOANUSANDHAN UNIVERSITY

antarmayee.pani@gmail.com8455018585

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 10, 2026