A Feasibility Study Comparing a Unani Regimen and Metformin in the management of Type 2 Diabetes Mellitus
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Change in Fasting Blood Sugar
Study Overview
Brief Summary
Diabetes is a chronic diseases characterized by elevated blood glucose concentration and the eighth leading cause of death and disability in the world. Use of unani medicine is quite popular in diabetes. Clinical experience has indicated that when QZK is administered in combination with Arq Maqo and Arq Kasni, the therapeutic outcomes appear significantly enhanced. This synergistic combination not only contributes to better glycemic control but may also positively influence related metabolic parameters—an essential aspect of holistic diabetes management in the Unani system. This pilot feasibility study is designed to evaluate the practicability, safety, and preliminary glycaemic efficacy of the QZK–Arq Maqo–Arq Kasni regimen in comparison with standard Metformin therapy in patients with Type 2 Diabetes Mellitus (T2DM).A total of 7 adult patients diagnosed with T2DM will be enrolled and randomly assigned to two groups: Group A: Standard therapy with Metformin Group B: Unani regimen comprising QZK along with Arq Maqo and Arq Kasni, selected based on classical Unani literature and clinical practice. The primary aim is to assess the feasibility of conducting a larger randomized controlled trial by evaluating recruitment and retention rates, patient adherence, safety/tolerability of interventions, and initial clinical outcomes. Preliminary changes in Fasting Blood Sugar (FBS), Postprandial Blood Sugar (PPBS), and HbA1c will be measured over a defined treatment period. Additionally, patients will be monitored for adverse effects and symptomatic improvement, providing early insight into the safety and potential efficacy of the Unani regimen. The outcomes of this pilot study will help optimize methodology, refine dosage protocols, and guide the design of future large-scale studies exploring integrative approaches to diabetes management using Unani medicine.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age greater than or equal to18 and less than or equal to 65 years
- •Not pre-treated with any ant diabetic agents within 2 months
- •Fasting Plasma Glucose Level between126 and 150 mg per dl
- •Random plasma glucose between 200 mg per dl and 250 mg per dl
- •HbA1c greater than or equal to 6.5percent
- •Body weight greater than 50 kg
- •Willingness to abstain from alcohol, tobacco, and any caffeine containing drinks during treatment periods
- •Ability to understand sign informed consent and comply with study protocol.
Exclusion Criteria
- •Pregnant and breastfeeding women,
- •Patients with Fasting Plasma Glucose level greater than or equal to 150mg per dl.
- •Patients with Post Prandial Plasma Glucose level greater than or equal to 150mg per dl
- •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
- •Evidence or a history of diabetes complications for example diabetic retinopathy neuropathy acute hyperglycaemic emergency and diabetic foot)
- •Any Seasonal illness lasting more than 10 days
- •Tobacco greater than or equal to 10 cigarettes per day within 3 months prior to screening or drug abuse.
Outcomes
Primary Outcomes
Change in Fasting Blood Sugar
Time Frame: 90 days
Change in Postprandial Blood Sugar PPBS
Time Frame: 90 days
Change in HbA1c levels.
Time Frame: 90 days
Secondary Outcomes
- Body weight and BMI(Lipid profile Total cholesterol LDL HDL Triglycerides.)
Investigators
Dr Arjumand
Regional Research Institute of Unani Medicine Naseem Bagh