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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

Primary Purpose

Antihyperglycemic Effect in Type 2 Diabetic Patients With Secondary Failure to Oral Hypoglycemic Agents

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Mersina
Sponsored by
Jyoti Clinical and Pathological Laboratory
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Antihyperglycemic Effect in Type 2 Diabetic Patients With Secondary Failure to Oral Hypoglycemic Agents focused on measuring Ayurvedic formulation, type 2 diabetes mellitus, secondary failure to oral hypoglycemic agents, antidiabetic

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jyoti Clinical and Pathological Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

CORN STARCH

Mersina, Diet and exercise

Arm Description

Outcomes

Primary Outcome Measures

antidiabetic activity

Secondary Outcome Measures

Improvement in metabolic, insulin level, HbA1c,kidney and lipid profile

Full Information

First Posted
July 14, 2009
Last Updated
July 14, 2009
Sponsor
Jyoti Clinical and Pathological Laboratory
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1. Study Identification

Unique Protocol Identification Number
NCT00940251
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Jyoti Clinical and Pathological Laboratory

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antihyperglycemic Effect in Type 2 Diabetic Patients With Secondary Failure to Oral Hypoglycemic Agents
Keywords
Ayurvedic formulation, type 2 diabetes mellitus, secondary failure to oral hypoglycemic agents, antidiabetic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CORN STARCH
Arm Type
Placebo Comparator
Arm Title
Mersina, Diet and exercise
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Mersina
Intervention Description
capsule, 3g/day, 3 months
Primary Outcome Measure Information:
Title
antidiabetic activity
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Improvement in metabolic, insulin level, HbA1c,kidney and lipid profile
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Jyoti Clinical and Pathological Laboratory
City
Shirpur
State/Province
Maharashtra
ZIP/Postal Code
425 405
Country
India

12. IPD Sharing Statement

Learn more about this trial

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

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