Overweight and ObesityPVE-AONCT05451927
Trial to Examine the Effect of Natural Anti- Obesity Agent (Phaseolus Vulgaris) Among Women of Lahore
A study testing Phaseolus Vulgaris in people with Overweight and Obesity, run by Hafiza Aisha Sadiqa at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Phaseolus Vulgaris
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesPakistan
- Study dates
- 27 Oct 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Akhuwat Medical Centre
Lahore, Punjab Province
Niazi Medical Centre
Lahore, Punjab Province
About this study
Official title: 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.
- Conditions
- Overweight and Obesity
- Being tested
- Phaseolus Vulgaris, Placebo
- Keywords
- Weight loss
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phaseolus VulgarisDietary supplement
Weight loss
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Phaseolus Vulgaris | Experimental | Three oral doses of 1000 mg Phaseolus Vulgaris daily for 3 months Receives: Dietary Supplement: Phaseolus Vulgaris |
| Placebo | Placebo comparator | Three oral doses of Placebo daily for 3 months Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
change in body weight
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start27 Oct 2022
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hafiza Aisha Sadiqa
- Sponsor type
- University, hospital or other
- Collaborators
- University of the Punjab
- Responsible party
- Sponsor-investigator, Hafiza Aisha Sadiqa, University of the Punjab
- Investigators
- Aisha Sadiqa, M.Phil, Principal investigator, University of the Punjab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451927
- Sponsor's protocol ID
- RCT012022
- Acronym
- PVE-AO
- Status last verified
- Apr 2024
- First submitted
- 1 Jul 2022
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD will be shared with other researchers subject to terms of Data Transfer Agreement and IRB approval
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blind Study to Examine the Effect of Natural Anti-obesity Agent Among Women of Lahore
- ClinicalTrials.gov ID
- NCT05451927
- Acronym / sponsor ID
- PVE-AO / RCT012022
- Conditions
- Overweight and Obesity
- Keywords
- Weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hafiza Aisha SadiqaUniversity, hospital or other
- Collaborators
- University of the Punjab
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phaseolus Vulgaris | Experimental | Dietary Supplement: Phaseolus VulgarisThree oral doses of 1000 mg Phaseolus Vulgaris daily for 3 months |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThree oral doses of Placebo daily for 3 months |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phaseolus VulgarisWeight loss | Dietary supplement | Phaseolus Vulgaris |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Body weight
Time frame: 3 months
change in body weight
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: Yes. De-identified IPD will be shared with other researchers subject to terms of Data Transfer Agreement and IRB approval
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aisha Sadiqa, M.Phil principal investigator
University of the Punjab
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phaseolus Vulgaris in people with Overweight and Obesity, run by Hafiza Aisha Sadiqa at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.