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

Obesity Control Through Leptogenic Drugs

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Leptin Deficiency
• Intervention / Treatment: Drug: Leptin Human

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.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 2

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Karachi, Punjab, Pakistan, 74600
      • clinical trial was conducted in Karachi,Islamabad and Faisalabad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Obesecure Capsules (Test Group); 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; Other Names: Obesecure
Placebo Comparator: Plasicure (Control Group); 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; Other Names: Obesecure

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hafiz Muhammad Asif
• Collaborators: Government College University Faisalabad; Hamdard University
• Investigators: Study Director: Ejaz Mohiuddin, Ph.D, Hamdard University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2015
• Primary Completion (Actual): March 20, 2018
• Study Completion (Actual): May 20, 2018

Study Registration Dates

• First Submitted: June 19, 2020
• First Submitted That Met QC Criteria: June 19, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Actual): June 23, 2020
• Last Update Submitted That Met QC Criteria: June 19, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: GCUF/ERC/1817

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be shared to other researchers on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No