Leptin Deficiency, Obesity
Conditions
Brief summary
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
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.
Interventions
DRUGLeptin Human
Sponsors
Hamdard University
Government College University Faisalabad
Hafiz Muhammad Asif
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicentre, two arm parallel randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients of age20 to 50 years with BMI more than 25 2. Only those participants were included who were willing 3. Patients of any marital status were included 4. Only those participants were included who did not take any antiobesity drug one-month prior to start of study
Exclusion criteria
1. Taking an anti-obesity drug in the previous month 2. Pregnant 3. Allergic to laxative drugs 4. Recurrent weight gain history after antiobesity treatment 5. Liver disease 6. Taking hormonal therapy, menopausal women 7. Diabetes mellitus 8. Cardiac problem and hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leptin Level | 3 months | Appetite suppression and energy dissipation |
| BMI (kg/m²) at baseline | 3 Months | weight reduction effects |
Countries
Pakistan
Outcome results
None listed