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OpenTrials
Completed

NCT Number: NCT04443790

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

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.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

clinical trial was conducted in Karachi,Islamabad and Faisalabad

Karachi, Punjab Province, 74600, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Leptin Human

Drug

Other names: Obesecure

Primary outcomes

  1. Leptin Level

    Time frame: 3 months

    Appetite suppression and energy dissipation

  2. BMI (kg/m²) at baseline

    Time frame: 3 Months

    weight reduction effects

Sponsors and collaborators

Lead sponsor

Hafiz Muhammad Asif

Other

Collaborators

  • Government College University Faisalabad
  • Hamdard University

Registry information

Official study title

Obesity Control Through Leptogenic Drugs

Acronym: CEOLO

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 23, 2020
Registry last updated
Jun 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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