NCT04557267

Brief Summary

This study has been designed as a randomized, double blinded, multi-centric, placebo controlled, and phase II dose-ranging study. The herbal drug contains bioactive ingredients from Labisia pumila plant and it is an aqueous ethanolic standardized extract (SKF7™).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for phase_2 obesity

Timeline
Completed

Started Sep 2020

Shorter than P25 for phase_2 obesity

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

September 7, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

September 30, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2021

Completed
Last Updated

June 3, 2021

Status Verified

June 1, 2021

Enrollment Period

8 months

First QC Date

September 7, 2020

Last Update Submit

June 2, 2021

Conditions

Obesity

Keywords

dose-rangingKacip FatimahLabisia pumilaobesity

Outcome Measures

Primary Outcomes (4)

  • Change in body weight

    Percentage of subjects whose Body Weight is lowered

    12 weeks

  • Change in waist and hip circumferences

    Change in waist and hip circumference

    12 weeks

  • Change in the waist-hip and waist-height ratios

    Change in waist-hip ratio and waist-height ratio

    12 weeks

  • Change in Body Mass Index (BMI)

    Change in BMI in kg/m\^2

    12 weeks

Secondary Outcomes (2)

  • Body fat percentage

    12 weeks

  • Lean Body Mass

    12 weeks

Other Outcomes (2)

  • Incidence of abnormal vital signs and of abnormal laboratory test results

    12 weeks

  • Incidence of Adverse Events

    12 weeks

Study Arms (4)

Group A (dosage A)

EXPERIMENTAL

The lower dose of the active drug

Drug: low-dose

Group B (dosage 2)

EXPERIMENTAL

The middle dose of the active drug

Drug: Middle-dose

Group C (dosage 3)

EXPERIMENTAL

The higher dose of the active drug

Drug: Higher-dose

Group D (placebo)

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

low-doseDRUG

Dosage 1

Group A (dosage A)
Middle-doseDRUG

Dosage 2

Group B (dosage 2)
Higher-doseDRUG

Dosage 3

Group C (dosage 3)
PlaceboDRUG

Placebo

Group D (placebo)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men aged 18 - 50 yrs or women aged 18 until before perimenopause, with obesity
  • Willing to participate in the study by signing the informed consent
  • Healthy by anamnesis
  • Agreed to maintain their current lifestyles (no changes in their diet and physical exercise) during the clinical trial period.

You may not qualify if:

  • Positive result for Rapid test for COVID-19 at screening period.
  • Known hypersensitivity to any herbal product.
  • Pregnant or lactating women.
  • Taking any other weight loss therapy and/or lipid lowering products.
  • Participate in other interventional clinical study or have taken other investigational drug within 30 days prior to screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Indonesia Medical Education and Research Institute

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Faculty of Medicine, Krida Wacana Christian University

Jakarta, DKI Jakarta, 11510, Indonesia

Location

Makara Satellite Clinic

Depok, West Java, 16424, Indonesia

Location

Related Publications (1)

  • Lee S, Lee H, Cho Y, Kim J, Kang JW, Seo BK, Baek YH, Lee JD. The efficacy and safety of Hanslim for obese patients: Study protocol for a multicenter, randomized, double-blind, multi-dose, placebo-controlled, phase IIb clinical trial. Medicine (Baltimore). 2018 Sep;97(38):e12440. doi: 10.1097/MD.0000000000012440.

    PMID: 30235727RESULT

Related Links

MeSH Terms

Conditions

Obesity

Interventions

Contraceptives, Oral

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Contraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic Uses

Study Officials

  • Arini Setiawati, PhD

    Clinical Research Supporting Unit, Faculty of Medicine, University of Indonesia

    STUDY CHAIR

  • Nafrialdi Agus, MD, PhD

    Pharmacology & Therapeutics, Faculty of Medicine, Universitas Indonesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Active drug and placebo are made in similar
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 4 parallel groups, 3 doses of study drug versus placebo
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 7, 2020

First Posted

September 21, 2020

Study Start

September 30, 2020

Primary Completion

May 20, 2021

Study Completion

May 22, 2021

Last Updated

June 3, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

ID(3)