Trial to Examine the Effect of Natural Anti- Obesity Agen... | NCT05451927

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

NCT05451927

Sponsor

Hafiza Aisha Sadiqa

Status

Completed

Last Update Posted

Apr 30, 2024Actual

Enrollment

72Actual

Phase

Not Applicable

Conditions

Overweight and Obesity

Interventions

Phaseolus Vulgaris
Placebo

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 27, 2022Actual

Primary Completion Date

Dec 30, 2023Actual

Completion Date

Dec 30, 2023Actual

First Submitted Date

Jul 1, 2022

First Submission Date that Met QC Criteria

Jul 6, 2022

First Posted Date

Jul 11, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2024

Last Update Posted Date

Apr 30, 2024Actual

Name	Class
University of the Punjab	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Phaseolus Vulgaris	Experimental	Three oral doses of 1000 mg Phaseolus Vulgaris daily for 3 months	Dietary Supplement: Phaseolus Vulgaris
Placebo	Placebo Comparator	Three oral doses of Placebo daily for 3 months	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Phaseolus Vulgaris	Dietary Supplement	Weight loss	Phaseolus Vulgaris

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Women, resident of Lahore, Pakistan

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aisha Sadiqa, M.Phil	University of the Punjab	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Akhuwat Medical Centre		Lahore	Punjab Province		Pakistan
Niazi Medical Centre

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Clinical Study Report (CSR)

Time Frame

Till 10 years after completion of trial

Access Criteria

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

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050177	Overweight
D009765	Obesity
D015431	Weight Loss

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided