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Clinical Trials/CTRI/2024/07/071330
CTRI/2024/07/071330Not yet recruitingPhase 3 4

Evaluation of Comparative Efficacy of Mushkakadi Gana Udvartana Vs Triphala Gana Udvartana in the management of Obesity (Sthoulya)

Mahatma Gandhi Ayurveda College and Research Centre Hirapur Salod Wardha1 site in 1 country60 target enrollmentStarted: September 1, 2024Last updated:

Trial Snapshot

Phase
Phase 3 4
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
To evaluate the efficacy of Mushkakadi Gana Churna Udvartana with reduction in weight BMI skin fold thickness anthropometric measurements

Study Overview

Brief Summary

The volunteer will be informed about the study protocol. Willing patients will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done. After selection, each patient will be assessed and selected accordingly to selection criteria. They are divided into two groups the trial is a Randomized single blind reference standard control superiority trial. It will include 17 days treatment and 16th day follow up period.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

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

Inclusion Criteria

  • Patients willing to participate after signing informed consent Patients between age group of 20-60 years of either sex Patients having BMI greater than 30 up to 40 kg per meter square.

Exclusion Criteria

  • Known case of Diabetes mellitus Cardiovascular and Renal Disorder Drug induced Obesity Hypothyroidism PCOS PCOD and any skin ailment Pregnant lady and Lactating mothers Not willing to continue treatment Any other illness developed during treatment.

Outcomes

Primary Outcomes

To evaluate the efficacy of Mushkakadi Gana Churna Udvartana with reduction in weight BMI skin fold thickness anthropometric measurements

Time Frame: 15days

Secondary Outcomes

  • To evaluate the efficacy of Triphala Gana Churna Udvartana with reduction in weight BMI skin fold thickness(15 days)

Investigators

Sponsor
Mahatma Gandhi Ayurveda College and Research Centre Hirapur Salod Wardha
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Kashmira Bhaidkar

Datta Meghe Institute of Higher Education and Research

Study Sites (1)

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