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Safety and Efficacy of Unani Formulation Versus Metformin in Type 2 Diabetes: A Clinical Study

A Randomized, open-label, parallel-group, active controlled clinical study to evaluate the safety and efficacy of a Unani formulation compared with Metformin in patients with Dhayabitus Harr [Type 2 Diabetes Mellitus (G-2)] - Nil

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097024
Enrollment
100
Registered
2025-11-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Intervention1: Unani formulation: Unani formulation is a powder drug of natural ingredients. The dose of the powder is 3 gm twice daily orally for 90 days. Control Intervention1: Metformin 500 mg: Tab

Sponsors

Central Council for Research in Unani Medicine
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Clinically diagnosed cases of Type 2 diabetes for at least 6 months prior to screening. HbA1c level equal to or more than 6.5 % at screening. Presence of any of the symptoms and signs of diabetes mellitus as per Unani Literature. Willing and able to provide written informed consent. Willing to comply with the protocol requirements.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Changes in the fasting and postprandial blood glucose Changes in the HbA1C from baseline to post-treatment at 90 days.Timepoint: Changes in the fasting and postprandial blood glucose Changes in the HbA1C from baseline to post-treatment at 90 days.

Secondary

MeasureTime frame
changes in the VAS score for clinical findings. Changes in the biomarkers.Timepoint: Changes in the VAS score at baseline and every 15 days up to 90 days. Changes in the biomarkers at baseline and at 90 days.

Countries

India

Contacts

Public ContactDr Mohammad Zakir

National Research Institute of Unani Medicine for Skin Disorders

zakir.rkt@gmail.com977635513

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026