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

Primary Purpose

Overweight and Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Phaseolus Vulgaris
Placebo
Sponsored by
Hafiza Aisha Sadiqa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Overweight and Obesity focused on measuring Weight loss

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Akhuwat Medical CentreRecruiting
  • Niazi Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Phaseolus Vulgaris

Placebo

Arm Description

Three oral doses of 1000 mg Phaseolus Vulgaris daily for 3 months

Three oral doses of Placebo daily for 3 months

Outcomes

Primary Outcome Measures

Body weight
change in body weight

Secondary Outcome Measures

Full Information

First Posted
July 1, 2022
Last Updated
May 9, 2023
Sponsor
Hafiza Aisha Sadiqa
Collaborators
University of the Punjab
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1. Study Identification

Unique Protocol Identification Number
NCT05451927
Brief Title
Trial to Examine the Effect of Natural Anti- Obesity Agent (Phaseolus Vulgaris) Among Women of Lahore
Acronym
PVE-AO
Official Title
A Randomized Double Blind Study to Examine the Effect of Natural Anti-obesity Agent Among Women of Lahore
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 27, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hafiza Aisha Sadiqa
Collaborators
University of the Punjab

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Weight loss

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phaseolus Vulgaris
Arm Type
Experimental
Arm Description
Three oral doses of 1000 mg Phaseolus Vulgaris daily for 3 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Three oral doses of Placebo daily for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Phaseolus Vulgaris
Intervention Description
Weight loss
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Body weight
Description
change in body weight
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women, resident of Lahore, Pakistan
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aisha Sadiqa, M.Phil
Phone
+923338179688
Email
asminhas3@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aisha Sadiqa, M.Phil
Organizational Affiliation
University of the Punjab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akhuwat Medical Centre
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Tahir Rasool
First Name & Middle Initial & Last Name & Degree
Dr. Tahir Rasool, MD
Facility Name
Niazi Medical Centre
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Nazia Ayyub, MD
First Name & Middle Initial & Last Name & Degree
Dr. Nazia Ayyub, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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