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

Obesity Clinical Trial

— CEOLO  

Official title:

Obesity Control Through Leptogenic Drugs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04443790
• Other study ID #: GCUF/ERC/1817
• Status: Completed
• Phase: Phase 2
• Start date: April 10, 2015
• Est. completion date: May 20, 2018

Study information

• Verified date: June 2020
• Source: Shifa Ul Mulk Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: May 20, 2018
• Est. primary completion date: March 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Leptin Deficiency
• Obesity
• Obesity, Morbid

Intervention

Drug:
• Leptin Human

Locations

Country	Name	City	State
Pakistan	clinical trial was conducted in Karachi,Islamabad and Faisalabad	Karachi	Punjab

Sponsors (3)

Lead Sponsor	Collaborator
Hafiz Muhammad Asif	Government College University Faisalabad, Hamdard University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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. Review. — View Citation

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;16:355. doi: 10.1186/s12906-016-1265-z. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leptin Level	Appetite suppression and energy dissipation	3 months
Primary	BMI (kg/m²) at baseline	weight reduction effects	3 Months