Efficacy of a Unani formulation in Diabetes

A Randomized, Parallel Group, Open-Label, Active Controlled Clinical Study to Evaluate Therapeutic Efficacy and Safety of a Unani Drug in Dhay ?bi?us ? ?rr Qism Th ?ni (Type 2 Diabetes Mellitus) - NA

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058765

Enrollment

Registered

2023-10-17

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases

Interventions

Intervention1: Study Group (Unani Drug group): Safuf-e-Chirchita: Method of Preparation- The drug will be prepared in single batch on the guidelines and preparation of drug in GMP certified pharmacy

Eligibility

Inclusion criteria

Inclusion criteria: 1 Patients of any gender in the age group of 30-65 years 2 Fasting Blood Glucose (FBG) Levels between 126 and 150 mg/dL (after an overnight fasting) or Post-Prandial Blood Glucose (PPBG) between 200 and 250 mg/dL (2 hours after ingestion of meal) 3 Glycated Haemoglobin (HbA1c) between 6.5% and 8% 4 Patient willing to sign the written informed consent with / without Presence of any of the following classical symptoms of Dhay ?bi?us ? ?rr Qism Th ?ni (Type 2 Diabetes Mellitus): ? U?ash Mufri? (Polydipsia) ? Kasrat al-Bawl (Polyuria) ? Kathrat al-Ishtih ? (Polyphagia) ? Naqs al-Wazn (Weight Loss) ? I’ya (Fatigue) ? ?u‘f (Weakness)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Change in FBG, PPBG, HbA1c from baseline to post treatment at 12 weeksTimepoint: At baseline, 2, 4, 6, 8, 10 and 12 weeks	—

Secondary

Measure	Time frame
Improvement in symptoms on VAS from baseline to post treatment at 12 weeksTimepoint: At baseline, 2, 4, 6, 8, 10 and 12 weeks	—

Countries

India

Contacts

Public ContactAbid

National Research Institute of Unani Medicine for Skin Disorders.

ccrumhqrsnd58@gmail.com8700027178

Outcome results

None listed

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