Dose-Ranging Study of SKF7® for Obesity

May 1, 2023 updated by: Medika Natura Sdn Bhd

Dose-ranging Study of Labisia Pumila 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. One group will receive placebo alone and the other three groups will receive IP twice daily (different dosages) for four months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Labisia pumila or Kacip Fatimah, a native Malaysian plant, has been used as traditional medicine for over 400 years by both men and women for multiple treatments. Studies in animal models showed that Labisia pumila extract could regulate body weight gain and visceral fat reduction. SKF7® is a standardized extract of Labisia pumila (Kacip Fatimah) from the Myrsinaceae family.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
142

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Ipoh, Malaysia
        • Klinik Kesihatan Greentown
      • Kuang, Malaysia
        • Klinik Kesihatan Kuang
      • Melaka, Malaysia
        • Hospital Melaka
      • Melaka, Malaysia
        • Klinik Kesihatan Masjid Tanah
      • Seremban, Malaysia
        • Klinik Kesihatan Seremban 2
      • Seremban, Malaysia
        • Hospital Tuanku Jaafar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Men aged 18 - 60 years.
  2. Women aged 18 until before menopause.
  3. BMI 30 - 37 kg/m2.
  4. Waist circumference ≥ 60% of height.
  5. Generally healthy or in the presence of co-morbidities of treated or untreated hypertension, diabetes or hyperlipidaemia.
  6. Normotension or well-controlled mild hypertension (< 140/90 mmHg) with stable dosage of not more than 2 class drug combination (except beta blocker and diuretic) for at least 1 month.
  7. Normoglycemic or non-insulin dependent diabetes mellitus (HbA1c ≤ 8.5%) with stable dosage of not more than 2 class drug combination (except sulphonylureas, TZDs and SGLT2 inhibitors) for at least 1 month.
  8. Normolipidaemia or hyperlipidaemia (LDL ≤ 4.1 mmol/L and TG ≤ 5.6 mmol/L) with stable dosage of not more than 2 class drug combination for at least 1 month.
  9. Agreed to maintain their current lifestyles (no changes in their diet and physical exercise) during the clinical trial period.
  10. Willing to participate in the study by signing the informed consent.
  11. Ability to provide written informed consent.

Exclusion Criteria:

  1. Known hypersensitivity to any herbal product.
  2. Known history of allergic reaction to microcrystalline cellulose, maltodextrin, tricalcium phosphate, silicon dioxide and glyceryl monostearate.
  3. Pregnant or lactating women.
  4. Taking any other weight loss therapy or who have lost more than 10% of their body weight within the last 6 months.
  5. Taking regular herbal drugs or any supplements unless subjects willing to stop during the study.
  6. Known HIV subjects.
  7. Severe liver function impairment (ALT & AST > 3x ULN (upper limit of normal)
  8. Renal function impairment (serum creatinine > 132.6 µmol/L)
  9. Participating in other interventional clinical study or have taken other investigational drug within 30 days prior to screening.
  10. Having endocrine disease that may affect weight such as hypothyroidism or Cushing's syndrome (by anamnesis).
  11. Taking hormonal contraceptive within the last 3 months or planning to use it during the study.
  12. Female patient of childbearing potential who is planning to get pregnant/male patient who is planning to have a child or do not agree to use non-hormonal contraception for the entire duration of the study.
  13. Having heart diseases (e.g. heart failure, angina pectoris, or myocardial infarction), respiratory diseases (e.g. asthma or obstructive pulmonary disease), stroke, or ischemic heart failure.
  14. Having malignant tumors within the last 5 years.
  15. Participants who have narrow-angle glaucoma.
  16. Participants who have cholelithiasis.
  17. Participants with a neurologically or psychologically significant history of disease or who are currently suffering from the disease (e.g. schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, hyperphagia, etc.).
  18. Participants who have taken oral steroids (e.g. prednisone or its equivalent) within the last 3 months that may affect weight.
  19. Participants who have taken b-blocker or diuretic drugs for hypertension, anorexiants, laxatives, thyroid hormone, amphetamine, cyproheptadine, phenothiazine, contraceptive or female hormones within the last 3 months that may affect weight.
  20. Participants who have taken other treatments (e.g. insulin, blood thinning, antidepressants, selective serotonin reuptake inhibitors (SSRIs), barbiturate, antipsychotics, antiepileptic, or drugs concerned with abuse) within the last 5 years.
  21. Participants who have anatomical condition or underwent anatomical changes which make it difficult/unable to conduct physical measurements.
  22. Participants who underwent surgeries for weight reduction (e.g., gastroplasty or gastrectomy).
  23. Participants who are judged as unable to comply with the study according to the findings of the clinical investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Other: SKF7® Labisia pumila standardized extract
Botanical extract of Labisia pumila (Kacip Fatimah)
Other Names:
  • SKF7®
Experimental: SKF7® - 375 mg
Patients who meet the entry criteria for the study will be randomized to receive 375 mg SKF7® for 16 weeks
Other: SKF7® Labisia pumila standardized extract
Botanical extract of Labisia pumila (Kacip Fatimah)
Other Names:
  • SKF7®
Experimental: SKF7® - 562.5 mg
Patients who meet the entry criteria for the study will be randomized to receive 562.5 mg SKF7® for 16 weeks
Other: SKF7® Labisia pumila standardized extract
Botanical extract of Labisia pumila (Kacip Fatimah)
Other Names:
  • SKF7®
Experimental: SKF7® - 750 mg
Patients who meet the entry criteria for the study will be randomised to receive 750 mg SKF7® for 16 weeks
Other: SKF7® Labisia pumila standardized extract
Botanical extract of Labisia pumila (Kacip Fatimah)
Other Names:
  • SKF7®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of patients achieving more than or equal to 5% weight loss OR
Time Frame: Baseline Day 1 to Week 16
Percentage of patients achieving more than or equal to 5% weight loss for SKF7® (375 mg, 562.5 mg and 750 mg) versus placebo
Baseline Day 1 to Week 16
Percentage of patients achieving more than or equal to 5 cm waist circumference reduction
Time Frame: Baseline Day 1 to Week 16
Percentage of patients achieving more than or equal to 5 cm waist circumference reduction for SKF7® (375 mg, 562.5 mg and 750 mg) versus placebo
Baseline Day 1 to Week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage change from baseline in body weight (kg) at week 16
Time Frame: Baseline Day 1 to Week 16
SKF7® (375 mg, 562.5 mg and 750 mg) versus placebo
Baseline Day 1 to Week 16
Percentage change from baseline in waist circumference (cm) at week 16
Time Frame: Baseline Day 1 to Week 16
SKF7® (375 mg, 562.5 mg and 750 mg) versus placebo
Baseline Day 1 to Week 16
Percentage change from baseline in waist to height ratio at week 16
Time Frame: Baseline Day 1 to Week 16
SKF7® (375 mg, 562.5 mg and 750 mg) versus placebo
Baseline Day 1 to Week 16
Percentage change from baseline in BMI at week 16
Time Frame: Baseline Day 1 to Week 16
SKF7® (375 mg, 562.5 mg and 750 mg) versus placebo
Baseline Day 1 to Week 16
Change in blood lipid concentrations.
Time Frame: Baseline Day 1 to Week 16
The change in blood lipid concentrations (total cholesterol, triglyceride, HDL & LDL)
Baseline Day 1 to Week 16
Incidence of AEs, SAEs and AEs leading to early discontinuation
Time Frame: Up to Follow up visit Up to Week 17
Incidence of AEs, SAEs and AEs leading to early discontinuation
Up to Follow up visit Up to Week 17

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medika Natura Sdn Bhd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zach Biotech Depot Sdn Bhd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shalini Vijayasingham, MBBS, MRCPS, Hospital Melaka, Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 12, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 8, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 8, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRSU-P-1-1019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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