A Phase 2 interventional study of Leptin Human in Leptin Deficiency and Obesity, sponsored by Hafiz Muhammad Asif. Completed at 1 site in Pakistan. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-23.
Sponsored by Hafiz Muhammad Asif · Phase 2, Interventional, and Treatment
The study was designed to explore an alternative approach to reduce weight in human beings using a polyherbal formulation. A polyherbal formulation named as Obesecure was developed after screening of local medicinal flora. The formulation was further improved after pilot studies and Phase-I Clinical Trials.
Obesity is a common disease of developing countries including Pakistan. Obesity is a risk factor for many diseases which can be life-threatening or making the person unable to perform daily routine work. Obesity is considered a risk factor for different diseases like cardiovascular diseases, hormonal imbalance, infections, malignancies and chest problems. The leptin hormone has appetite suppressing and energy dissipation activity in the body. A screening study on animals was carried out to find out the leptin enhancing medicinal plants from locally available plants in Pakistan. This study was aimed to see the combined effects of the Leptogenic drug Obesecure on weight management.
Patients of age20 to 50 years with BMI more than 25, not taking any anti-obesity drugs one-month prior to start of study were enrolled. The Participants were randomly allocated to receive either Obesecure or placebo twice a day for three months in Shifa-ul-mulk Hospital, PRIEM Health Care Clinic (Pakistan) and Ria Eastern Medicine Clinic (Pakistan).
An acute toxicity study showed no adverse effect of taking Obesecure prior to clinical trials.
936 studies on the registry are indexed under Obesity, Morbid; 169 are open to participants now.
This study's enrollment of 132 is above the median of 60 across 599 interventional studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Hafiz Muhammad Asif is the lead sponsor of 2 studies on the registry; none are open to participants now.
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A dose of 500mg capsule twice daily of Polyherbal formulation Obesecure was given in the test group for three months. Short term effectiveness was assessed by BMI calculation on follow up visit after two weeks and long term follow up was assessed by BMI and Leptin Level at three months.
Drug: Leptin Human
A dose of 500mg capsule twice daily of Placebo as Plasicure was given in the control group for three months. Short term effectiveness was assessed by BMI calculation on follow up visit after two weeks and long term follow up was assessed by BMI and Leptin Level at three months.
Drug: Leptin Human
Also known as: Obesecure
Leptin Level
Appetite suppression and energy dissipation
Time frame: 3 months
BMI (kg/m²) at baseline
weight reduction effects
Time frame: 3 Months
Plan to share: No — IPD will be shared to other researchers on request
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Leptin
Hafiz Muhammad Asif