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| Name | Class |
|---|---|
| Hamdard University | OTHER |
| Government College University Faisalabad | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obesecure Capsules (Test Group) | Active Comparator | 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. |
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| Plasicure (Control Group) | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leptin Human | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Leptin Level | Appetite suppression and energy dissipation | 3 months |
| BMI (kg/m²) at baseline | weight reduction effects | 3 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ejaz Mohiuddin, Ph.D | Hamdard University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| clinical trial was conducted in Karachi,Islamabad and Faisalabad | Karachi | Punjab Province | 74600 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27313173 | Background | Wasim M, Awan FR, Najam SS, Khan AR, Khan HN. Role of Leptin Deficiency, Inefficiency, and Leptin Receptors in Obesity. Biochem Genet. 2016 Oct;54(5):565-72. doi: 10.1007/s10528-016-9751-z. Epub 2016 Jun 16. | |
| 26313897 | Background | Farr OM, Gavrieli A, Mantzoros CS. Leptin applications in 2015: what have we learned about leptin and obesity? Curr Opin Endocrinol Diabetes Obes. 2015 Oct;22(5):353-9. doi: 10.1097/MED.0000000000000184. |
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IPD will be shared to other researchers on request
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Multicentre, two arm parallel randomized controlled clinical trial
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| 27618865 | Result | Lee JH, Lee JJ, Cho WK, Yim NH, Kim HK, Yun B, Ma JY. KBH-1, an herbal composition, improves hepatic steatosis and leptin resistance in high-fat diet-induced obese rats. BMC Complement Altern Med. 2016 Sep 13;16(1):355. doi: 10.1186/s12906-016-1265-z. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |