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A Feasibility Study Comparing a Unani Regimen and Metformin in the management of Type 2 Diabetes Mellitus

A Feasibility Study Comparing a Unani Regimen and Metformin in the management of Type 2 Diabetes Mellitus - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094234
Enrollment
14
Registered
2025-09-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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: Qurs-e-Ziabetes ,Arq Mako,Arq Kasni: Qurs Ziabetes is a tablet form of the drug will be given in dose of 3 tablets (750mg) thrice daily for 3 months Arq Mako and Arq Kasni are Distillat

Sponsors

Regional Research Institute of Unani Medicine, Srinagar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age greater than or equal to18 and less than or equal to 65 years 2. Not pre-treated with any ant diabetic agents within 2 months 3. Fasting Plasma Glucose Level between126 and 150 mg per dl 4. 2h plasma glucose between 200 mg per dl and 250 mg per dl 5. Random plasma glucose between 200 mg per dl and 250 mg per dl 6. HbA1c greater than or equal to 6.5percent 7. Body weight greater than 50 kg 8. Willingness to abstain from alcohol, tobacco, and any caffeine containing drinks during treatment periods 9. Ability to understand sign informed consent and comply with study protocol

Exclusion criteria

Exclusion criteria: 1. Pregnant and breastfeeding women, 2. Patients with Fasting Plasma Glucose level greater than or equal to 150mg per dl. 3. Patients with Post Prandial Plasma Glucose level greater than or equal to 150mg per dl 4. Significant pulmonary gastrointestinal cardiovascular hepatic-renal dysfunction. Diabetes Mellitus Type I or Diabetes Insipidus or Patient on Insulin Therapy HIV HCV HBSAG Cancer cardiovascular diseases autoimmune disorders 5. Evidence or a history of diabetes complications for example diabetic retinopathy neuropathy acute hyperglycaemic emergency and diabetic foot) 6. Any Seasonal illness lasting more than 10 days 7. Tobacco greater than or equal to 10 cigarettes per day within 3 months prior to screening or drug abuse

Design outcomes

Primary

MeasureTime frame
Change in Fasting Blood Sugar Change in Postprandial Blood Sugar PPBS Change in HbA1c levels. Timepoint: 90 days

Secondary

MeasureTime frame
Body weight and BMI Lipid profile Total cholesterol LDL HDL Triglycerides. Liver and kidney function tests to assess safety Patient reported outcomes like fatigue thirst polyuria etc Timepoint: 90 days

Countries

India

Contacts

Public ContactDr Arjumand

Regional Research Institute of Unani Medicine Naseem Bagh

dr.arjumandshah111@gmail.com7006180746

Outcome results

None listed

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