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Clinical Trials/CTRI/2009/091/000702
CTRI/2009/091/000702CompletedPhase 2

A clinical study of a herbal formulation 'Diabeat' as an adjuvant drug for the control of type 2 diabetes mellitus

Hamdard National Foundation New DElhi1 site in 1 country50 target enrollmentStarted: October 23, 2011Last updated:
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Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Mean HbA1C 6.5%
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Random Number Table
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
30.00 Year(s) to 60.00 Year(s) (—)
Sex
All

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/m
  • •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.

Outcomes

Primary Outcomes

Mean HbA1C 6.5%

Time Frame: 12 weeks

Secondary Outcomes

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

Investigators

Sponsor
Hamdard National Foundation New DElhi
Sponsor Class
Pharmaceutical industry-Indian

Study Sites (1)

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