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Dose-ranging Study of SKF7™ for Obesity

NCT04557267 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2021-06-03

No results posted yet for this study

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™).

Conditions

Interventions

DRUG

low-dose

Dosage 1

DRUG

Middle-dose

Dosage 2

DRUG

Higher-dose

Dosage 3

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Medika Natura Sdn Bhd

    collaborator INDUSTRY

  • Indonesia University

    lead OTHER

Principal Investigators

  • Arini Setiawati, PhD · Clinical Research Supporting Unit, Faculty of Medicine, University of Indonesia

  • Nafrialdi Agus, MD, PhD · Pharmacology & Therapeutics, Faculty of Medicine, Universitas Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2021-05-20
Completion
2021-05-22

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04557267 on ClinicalTrials.gov