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Evaluation of Safety and Efficacy of Mersina, an Ayurvedic Formulation: A Double Blind, Placebo Controlled Study in Type 2 Diabetic Patients With Secondary Failure to Oral Drugs

This study has been completed.
Sponsor:
Information provided by:
Jyoti Clinical and Pathological Laboratory
ClinicalTrials.gov Identifier:
NCT00940251
First received: July 14, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

To determine the safety and efficacy of an Ayurvedic formulation, Mersina in type 2 diabetic patients with secondary failure to oral hypoglycemic agents, a randomized double blind, single centre, study of 3 months duration was carried out.


Condition Intervention Phase
Antihyperglycemic Effect in Type 2 Diabetic Patients With Secondary Failure to Oral Hypoglycemic Agents
 Drug: Mersina
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Efficacy of Mersina, an Ayurvedic Formulation: A Double Blind, Placebo Controlled Study in Type 2 Diabetic Patients With Secondary Failure to Oral Drugs

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Jyoti Clinical and Pathological Laboratory:

Primary Outcome Measures:
  • antidiabetic activity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement in metabolic, insulin level, HbA1c,kidney and lipid profile [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 26
Study Start Date: September 2008
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: CORN STARCH Drug: Mersina
capsule, 3g/day, 3 months
Active Comparator: Mersina, Diet and exercise Drug: Mersina
capsule, 3g/day, 3 months

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Secondary failure to Oral Hypoglycemic Agents was diagnosed if the patient had HbA1c levels > 8.5% even after supplementation of maximal dose of a combination of a sulphonylurea (15 mg glybenclamide or 160 mg gliclazide or 15 mg glipizide) and metformin 1500 mg/day.

Exclusion Criteria:

Patients with ketosis, diabetes related complications, hepatic or renal disease, pancreatitis, cardiac problems, uncontrolled hypertension, malnutrition and severe immune deficiency

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940251

Locations
India
Jyoti Clinical and Pathological Laboratory
Shirpur, Maharashtra, India, 425 405
Sponsors and Collaborators
Jyoti Clinical and Pathological Laboratory
  More Information

No publications provided

Responsible Party: Jayavant M Jain, Jyoti Clinical and Pathological Laboratory
ClinicalTrials.gov Identifier: NCT00940251     History of Changes
Other Study ID Numbers: MER1
Study First Received: July 14, 2009
Last Updated: July 14, 2009
Health Authority: India: Indian Council of Medical Research

Keywords provided by Jyoti Clinical and Pathological Laboratory:
Ayurvedic formulation
type 2 diabetes mellitus
secondary failure to oral hypoglycemic agents
antidiabetic

ClinicalTrials.gov processed this record on May 23, 2013