Clinical Evaluation of Polyherbal Coded Formulation Obesecure for Leptin Regulation and Obesity Management

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Obesity Control Through Leptogenic Drugs

Conditions
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Leptin Deficiency, Obesity

Intervention / Treatment
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* Drug: Leptin Human


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of age20 to 50 years with BMI more than 25 Only those participants were included who were willing Patients of any marital status were included Only those participants were included who did not take any antiobesity drug one-month prior to start of study Exclusion Criteria: Taking an anti-obesity drug in the previous month Pregnant Allergic to laxative drugs Recurrent weight gain history after antiobesity treatment Liver disease Taking hormonal therapy, menopausal women Diabetes mellitus Cardiac problem and hypertension

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicentre, two arm parallel randomized controlled clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Obesecure Capsules (Test Group)<br>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<br> <br> * Other names: Obesecure;|
| Placebo Comparator: Plasicure (Control Group)<br>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<br> <br> * Other names: Obesecure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leptin Level | Appetite suppression and energy dissipation | 3 months | 
| BMI (kg/m²) at baseline | weight reduction effects | 3 Months |