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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:
ClinicalTrials.gov Identifier:
NCT00940251
First Posted: July 15, 2009
Last Update Posted: July 15, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Jyoti Clinical and Pathological Laboratory
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

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

Primary Outcome Measures:
  • antidiabetic activity [ Time Frame: 3 months ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00940251


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

Responsible Party: Jayavant M Jain, Jyoti Clinical and Pathological Laboratory
ClinicalTrials.gov Identifier: NCT00940251     History of Changes
Other Study ID Numbers: MER1
First Submitted: July 14, 2009
First Posted: July 15, 2009
Last Update Posted: July 15, 2009
Last Verified: July 2009

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

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes