A Clinical trial to study the effects of a unani formulation 'Diabeat'in patients with high blood sugar levels (Type 2 diabetes mellitus )

Phase 2

Completed

• Conditions: Type 2 Diabetes mellitus

• Registration Number: CTRI/2009/091/000702
• Lead Sponsor: Hamdard National Foundation New DElhi

Brief Summary

This study is a randomized, double blind parallel group, trial comparing the safety and efficacy of 'Diabeat'(1gram twice daily) plus standard drug(Metformin SR-500 mgtwice daily)with placebo (1gram twice daily)plus standard drug(Metformin SR-500mg twice daily)in 100 patients of Type 2 diabetes mellitus that will be conducted in Majeedia Hospital,New Delhi. The primary outcome measures will be To achieve a good glycemic control (FPG-80-120 mg/dl; PPG-80-140 mg/dl,Time point:4,8,12 weeks . The secondary outcome will be Mean HbA1C< 6.5%, Time point: 3 months

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-23
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients of type-2 diabetes mellitus, age 30-60 years taking Metformin for more than 3 months with uncontrolled hyperglycaemia i.e.HbA1C between 7% to 9% and Body Mass Index (BMI) between 25-29.9 kg/m2.
• Patients who are able and willing to follow anti-diabetic therapy under a stable life style and diabetic diet.
• 3.Patients who are willing and able to understand and follow the protocol and provide informed consent.

Exclusion Criteria

• 1.History of treatment with any insulin 2.Diabetes mellitus with complications 3.Pregnant or Lactating women 4.Women of childbearing potential who do not take adequate contraceptive protection.
• 5.History of hypersensitivity to the Metformin or to drug with similar chemical structure.
• 6.History of any severe systemic disease.
• 7.Patients with uncontrolled hypertension.
• 8.History of drug or alcohol abuse.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean HbA1C 6.5%	12 weeks

Secondary Outcome Measures

Name	Time	Method
To achieve a good glycemic control (FPG-80-120 mg/dl; PPG-80-140 mg/dl)	4,8,12 week

Trial Locations

Locations (1)

Majeedia Hospital, Jamia Hamdard, New Delhi; 🇮🇳 Delhi, DELHI, India

Majeedia Hospital, Jamia Hamdard, New Delhi

🇮🇳Delhi, DELHI, India

Dr. Yasmeen Shamsi

Principal investigator

01165741409

yasmeen.ijum@gmail.com