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Clinical Trials/CTRI/2024/06/068972
CTRI/2024/06/068972Not yet recruitingPhase 4

Efficacy of Myo-inositol as an add-on therapy to life style modifications in PCOS patients in Kerala population.

Amrita Institute Of Medical Science1 site in 1 country60 target enrollmentStarted: June 20, 2024Last updated:

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
To assess the efficacy of Myo-Inositol as an add on therapy to life style modifications in terms of Hormonal ,Metabolic and Clinical profile in Polycystic ovarian syndrome patients in Kerala population

Study Overview

Brief Summary

Myo-inositol has a beneficial effect on PCOS due to its insulin sensitising activity. However current management guidelines do not use the drug as a first line therapy to combat Insulin resistance.  Hence we propose to study the Efficacy of Myo-inositol as an add-on therapy to life style modifications in PCOS patients coming to our Out-patient department in terms of Hormonal ,Metabolic and Clinical profile in South Indian population

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
15.00 Year(s) to 45.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Rotterdam criteria.

Exclusion Criteria

  • secondary causes of PCOS.

Outcomes

Primary Outcomes

To assess the efficacy of Myo-Inositol as an add on therapy to life style modifications in terms of Hormonal ,Metabolic and Clinical profile in Polycystic ovarian syndrome patients in Kerala population

Time Frame: Samples will be taken at baseline and end of 6 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Amrita Institute Of Medical Science
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Malini Ajayan

Amrita Institute Of Medical Science

Study Sites (1)

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Efficacy of Myo-inositol in PCOS patients | Clinical Trial