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ObesityPhase 2NCT04557267

Dose-ranging Study of SKF7™ for Obesity

A Phase 2 study testing low-dose, Middle-dose and Higher-dose in people with Obesity, run by Universitas Indonesia at 3 sites in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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™). Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
low-dose, Middle-dose and Higher-dose
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
3 sitesIndonesia
Study dates
30 Sep 2020to 22 May 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

Indonesia3 sites

  • Makara Satellite Clinic

    Depok, West Java, 16424

  • Indonesia Medical Education and Research Institute

    Jakarta, DKI Jakarta, 10430

  • Faculty of Medicine, Krida Wacana Christian University

    Jakarta, DKI Jakarta, 11510

Other trials in Indonesia

About this study

Official title: Dose-ranging Study of Labisia Pumila Aqueous Ethanolic Standardized Extract (SKF7™) for Obesity: a Randomized, Double-blind, Placebo-controlled, Phase-2 Study

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™).

Read the detailed description

Labisia pumila or Kacip Fatimah is a native Malaysian and Indonesian plant. It has been used as traditional medicine for over 400 years by both men and women for multiple treatments including toning and firming the abdominal area. As a water-ethanol dry extract, it has been reported to reduce body weight, cholesterol level and triglyceride level, and regulate blood glucose and sex hormones. In Malaysia, this Kacip Fatimah extract has been used as a natural anti-obesity drug and dietary supplement for healthy weight loss and healthy body by the trade-name of Labeesity® or SKF7™. This extract has been shown to be pesticide / herbicide free and has branded halal ingredient identity and security.

Conditions
Obesity
Being tested
low-dose, Middle-dose, Higher-dose, Placebo
Keywords
dose-ranging, Kacip Fatimah, Labisia pumila, obesity
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • low-doseDrug

    Dosage 1

  • Middle-doseDrug

    Dosage 2

  • Higher-doseDrug

    Dosage 3

  • PlaceboDrug

    Placebo

Study groups in NCT04557267
Study groupRoleWhat they receive
Group A (dosage A)ExperimentalThe lower dose of the active drug
Receives: Drug: low-dose
Group B (dosage 2)ExperimentalThe middle dose of the active drug
Receives: Drug: Middle-dose
Group C (dosage 3)ExperimentalThe higher dose of the active drug
Receives: Drug: Higher-dose
Group D (placebo)Placebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in body weight

    Percentage of subjects whose Body Weight is lowered

    Measured: 12 weeks

  2. Change in waist and hip circumferences

    Change in waist and hip circumference

    Measured: 12 weeks

  3. Change in the waist-hip and waist-height ratios

    Change in waist-hip ratio and waist-height ratio

    Measured: 12 weeks

  4. Change in Body Mass Index (BMI)

    Change in BMI in kg/m^2

    Measured: 12 weeks

Secondary outcomes (2)

  1. Body fat percentage

    The change of body fat percentage

    Measured: 12 weeks

  2. Lean Body Mass

    The amount of lean body mass will be calculated from body fat percentage

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2020
  2. Study start30 Sep 2020
  3. Primary completion20 May 2021
  4. Study completion22 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
4 parallel groups, 3 doses of study drug versus placebo
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04557267
Sponsor's protocol ID
CRSU.P.SKF7F2/1019/04.08
Status last verified
Jun 2021
First submitted
7 Sep 2020
Last updated
3 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30235727

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing low-dose, Middle-dose and Higher-dose in people with Obesity, run by Universitas Indonesia at 3 sites in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in body weight (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04557267, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021.

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