NCT04443790

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2018

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
Last Updated

June 23, 2020

Status Verified

June 1, 2020

Enrollment Period

2.9 years

First QC Date

June 19, 2020

Last Update Submit

June 19, 2020

Conditions

Leptin DeficiencyObesity

Outcome Measures

Primary Outcomes (2)

  • Leptin Level

    Appetite suppression and energy dissipation

    3 months

  • BMI (kg/m²) at baseline

    weight reduction effects

    3 Months

Study Arms (2)

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.

Drug: Leptin Human

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.

Drug: Leptin Human

Interventions

Leptin HumanDRUG
Also known as: Obesecure
Obesecure Capsules (Test Group)Plasicure (Control Group)

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

clinical trial was conducted in Karachi,Islamabad and Faisalabad

Karachi, Punjab Province, 74600, Pakistan

Location

Related Publications (3)

  • 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.

    PMID: 27313173BACKGROUND

  • 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.

    PMID: 26313897BACKGROUND

  • 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.

    PMID: 27618865RESULT

MeSH Terms

Conditions

Obesity, MorbidObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ejaz Mohiuddin, Ph.D

    Hamdard University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multicentre, two arm parallel randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Trials Registrar for Shifaulmulk

Study Record Dates

First Submitted

June 19, 2020

First Posted

June 23, 2020

Study Start

April 10, 2015

Primary Completion

March 20, 2018

Study Completion

May 20, 2018

Last Updated

June 23, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

IPD will be shared to other researchers on request

Locations

PA(1)