Safety and efficacy of Unani formulation in Diabetes Mellitus

A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to Compare the Safety and Efficacy of Safuf-i-Dhayabitus (a Unani Formulation) With Metformin in the Management of Dhayabitus Harr Qism Thani (Type 2 Diabetes Mellitus ) - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/082396

Enrollment

Registered

2025-03-17

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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: Safuf-i-Dhayabitus (Oral): 1. Safuf-i-Dhayabitus : Dosage Form: Safuf(Powder) Dose: 3gm BD Mode of Administration: Oral Composition: 1. Gurmar Boooti(Gymnema sylvestre Retz.) 2. Jamun(S

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria: The following patients will be included in the study: 1. Patients of any sex aged thirty to sixty-five years. 2. Fasting Blood Glucose (FBG) Levels between 126 and 150 mg/dL (after 8-12 hours of fasting) or 3. Post-Prandial Blood Glucose (PPBG) Level between 200 and 250 mg/dL (after 2 hours of ingestion of meal). 4. Glycated Haemoglobin (HbA1c) between 6.5% and 8%. 5. Patient willing to sign the written informed consent with / without. 6. Presence of any of the following classical symptoms of Dhayabitus Harr Qism Thani (Type 2 Diabetes Mellitus): 7. Utash Mufrit (Polydipsia) 8. Kasrat al-Bawl (Polyuria) 9. Kasrat al-Ishtiha (Polyphagia) 10. Bawl Layli (Nocturia) 11. Burning sensation in palms and soles 12. Naqs al-Wazn (Weight Loss) 13. Iya (Fatigue) 14. Zoaf-i-Am (General Weakness) 15. Giddiness

Exclusion criteria

Exclusion criteria: The following patients will be excluded: 1. Patients aged less than 30 years or more than 65 years. 2. Participants with fasting plasma glucose level more than 150 mg/dL and /or PP plasma glucose level more than 250 mg/dL and/ or HbA1c greater than 8 percent. 3. Pregnant or Lactating Women. 4. Type 1 Diabetes Mellitus. 5. Type 2 DM with complications. 6. Obese Individuals BMI greater than 35. 7. Drug Addicts/ Alcoholics. 8. Any disorder requiring long-term treatment. 9. Patient on any other treatment for diabetes. 10. Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction. 11. Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies. 12. Patient not willing to attend treatment schedule regularly.

Design outcomes

Primary

Measure	Time frame
1. Change in Fasting Blood Glucose (FBG) level as compared to baseline 2. Change in Post-Prandial Blood Glucose (PPBG) level 3. Decrease in HbA1C level by greater than or equal to 1% as compared to baseline Timepoint: At baseline, 2, 4, 6, 8, 10 and 12 weeks	—

Secondary

Measure	Time frame
1. Improvement in symptoms on VAS ScaleTimepoint: At baseline, 2, 4, 6, 8, 10 and 12 weeks	—

Countries

India

Contacts

Public ContactProf Mohammad Nasar

National Research Institute of Unani Medicine for Skin Disorders

drnasar.nriumsd@gmail.com8328446962

Outcome results

None listed

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