Trial to Examine the Effect of Natural Anti- Obesity Agent (Phaseolus Vulgaris) Among Women of Lahore (PVE-AO)

April 28, 2024 updated by: Hafiza Aisha Sadiqa

A Randomized Double Blind Study to Examine the Effect of Natural Anti-obesity Agent Among Women of Lahore

This double-blind randomized placebo-controlled trial will test the hypothesis that administration of Phaseolus Vulgaris supplementation to women in Lahore, Pakistan, who are overweight will induce the weight loss (Primary outcome) and changes in body composition (Waist circumference) secondary outcome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Akhuwat Medical Centre
      • Lahore, Punjab, Pakistan
        • Niazi Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • BMI ranges from 25-40
  • Consistently stable body weight for at least 6 months
  • Good general health
  • No ongoing drug treatment for weight reduction
  • Commitment to avoid any changes in lifestyle throughout the test period
  • Age between 18-45 years
  • Women resident of Lahore

Exclusion Criteria:

  • Pregnant or breast-feeding females
  • People with Type 2 diabetes
  • People with any other chronic diseases
  • Weight reduction treatment during the 6 months prior to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phaseolus Vulgaris
Three oral doses of 1000 mg Phaseolus Vulgaris daily for 3 months
Dietary supplement: Phaseolus Vulgaris
Weight loss
Placebo Comparator: Placebo
Three oral doses of Placebo daily for 3 months
Dietary supplement: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight
Time Frame: 3 months
change in body weight
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hafiza Aisha Sadiqa

Collaborators

University of the Punjab

Investigators

  • Principal Investigator: Aisha Sadiqa, M.Phil, University of the Punjab

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2022

Primary Completion (Actual)

December 30, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

July 1, 2022

First Submitted That Met QC Criteria

July 6, 2022

First Posted (Actual)

July 11, 2022

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 28, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCT012022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified IPD will be shared with other researchers subject to terms of Data Transfer Agreement and IRB approval

IPD Sharing Time Frame

Till 10 years after completion of trial

IPD Sharing Access Criteria

on request through email and after Data Transfer Agreement and IRB approval

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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