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ObesityPhase 2NCT05851599

Dose-Ranging Study of SKF7® for Obesity

A Phase 2 study testing SKF7® Labisia pumila standardized extract in people with Obesity, run by Medika Natura Sdn Bhd at 6 sites in Malaysia.

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. One group will receive placebo alone and the other three groups will receive IP twice daily (different dosages) for four months. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
SKF7® Labisia pumila standardized extract
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
142 participants
Where
6 sitesMalaysia
Study dates
12 Oct 2020to 8 Aug 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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Men aged 18 - 60 years.
  • Women aged 18 until before menopause.
  • BMI 30 - 37 kg/m2.
  • Waist circumference ≥ 60% of height.
  • Generally healthy or in the presence of co-morbidities of treated or untreated hypertension, diabetes or hyperlipidaemia.
  • 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.
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  • 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.
  • 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.
  • Agreed to maintain their current lifestyles (no changes in their diet and physical exercise) during the clinical trial period.
  • Willing to participate in the study by signing the informed consent.
  • Ability to provide written informed consent.

Who cannot join

  • Known hypersensitivity to any herbal product.
  • Known history of allergic reaction to microcrystalline cellulose, maltodextrin, tricalcium phosphate, silicon dioxide and glyceryl monostearate.
  • Pregnant or lactating women.
  • Taking any other weight loss therapy or who have lost more than 10% of their body weight within the last 6 months.
  • Taking regular herbal drugs or any supplements unless subjects willing to stop during the study.
  • Known HIV subjects.
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  • Severe liver function impairment (ALT \& AST > 3x ULN (upper limit of normal)
  • Renal function impairment (serum creatinine > 132.6 µmol/L)
  • Participating in other interventional clinical study or have taken other investigational drug within 30 days prior to screening.
  • Having endocrine disease that may affect weight such as hypothyroidism or Cushing's syndrome (by anamnesis).
  • Taking hormonal contraceptive within the last 3 months or planning to use it during the study.
  • 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.
  • 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.
  • Having malignant tumors within the last 5 years.
  • Participants who have narrow-angle glaucoma.
  • Participants who have cholelithiasis.
  • 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.).
  • Participants who have taken oral steroids (e.g. prednisone or its equivalent) within the last 3 months that may affect weight.
  • 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.
  • 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.
  • Participants who have anatomical condition or underwent anatomical changes which make it difficult/unable to conduct physical measurements.
  • Participants who underwent surgeries for weight reduction (e.g., gastroplasty or gastrectomy).
  • Participants who are judged as unable to comply with the study according to the findings of the clinical investigator.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Malaysia6 sites

  • Klinik Kesihatan Greentown

    Ipoh

  • Klinik Kesihatan Kuang

    Kuang

  • Hospital Melaka

    Malacca

  • Klinik Kesihatan Masjid Tanah

    Malacca

  • Hospital Tuanku Jaafar

    Seremban

  • Klinik Kesihatan Seremban 2

    Seremban

Other trials in Malaysia

About this study

Official title: 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.

Read the 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.

Conditions
Obesity
Being tested
SKF7® Labisia pumila standardized extract
Medical subject headings
Obesity

What participants receive

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

  • SKF7® Labisia pumila standardized extractOther

    Also called SKF7®

    Botanical extract of Labisia pumila (Kacip Fatimah)

Study groups in NCT05851599
Study groupRoleWhat they receive
SKF7® - 375 mgExperimentalPatients who meet the entry criteria for the study will be randomized to receive 375 mg SKF7® for 16 weeks
Receives: Other: SKF7® Labisia pumila standardized extract
SKF7® - 562.5 mgExperimentalPatients who meet the entry criteria for the study will be randomized to receive 562.5 mg SKF7® for 16 weeks
Receives: Other: SKF7® Labisia pumila standardized extract
SKF7® - 750 mgExperimentalPatients who meet the entry criteria for the study will be randomised to receive 750 mg SKF7® for 16 weeks
Receives: Other: SKF7® Labisia pumila standardized extract
PlaceboPlacebo comparatorPlacebo
Receives: Other: SKF7® Labisia pumila standardized extract

What is being measured

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

  1. Percentage of patients achieving more than or equal to 5% weight loss OR

    Percentage of patients achieving more than or equal to 5% weight loss for SKF7® (375 mg, 562.5 mg and 750 mg) versus placebo

    Measured: Baseline Day 1 to Week 16

  2. Percentage of patients achieving more than or equal to 5 cm waist circumference reduction

    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

    Measured: Baseline Day 1 to Week 16

Secondary outcomes (6)

  1. Percentage change from baseline in body weight (kg) at week 16

    SKF7® (375 mg, 562.5 mg and 750 mg) versus placebo

    Measured: Baseline Day 1 to Week 16

  2. Percentage change from baseline in waist circumference (cm) at week 16

    SKF7® (375 mg, 562.5 mg and 750 mg) versus placebo

    Measured: Baseline Day 1 to Week 16

  3. Percentage change from baseline in waist to height ratio at week 16

    SKF7® (375 mg, 562.5 mg and 750 mg) versus placebo

    Measured: Baseline Day 1 to Week 16

  4. Percentage change from baseline in BMI at week 16

    SKF7® (375 mg, 562.5 mg and 750 mg) versus placebo

    Measured: Baseline Day 1 to Week 16

  5. Change in blood lipid concentrations.

    The change in blood lipid concentrations (total cholesterol, triglyceride, HDL \& LDL)

    Measured: Baseline Day 1 to Week 16

  6. Incidence of AEs, SAEs and AEs leading to early discontinuation

    Incidence of AEs, SAEs and AEs leading to early discontinuation

    Measured: Up to Follow up visit Up to Week 17

Timeline

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

  1. First posted9 May 2023
  2. Study start12 Oct 2020
  3. Primary completion8 Aug 2021
  4. Study completion8 Aug 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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05851599
Sponsor's protocol ID
CRSU-P-1-1019
Status last verified
May 2023
First submitted
31 Jan 2023
Last updated
9 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Swarna Nantha Y, Vijayasingham S, Adam NL, Vengadasalam P, Ismail M, Ali N, Chang LC, Ling LYL, Tee TT, Cheah YH. Labisia pumila standardized extract (SKF7(R)) reduces percentage of waist circumference and waist-to-height ratio in individuals with obesity. Diabetes Obes Metab. 2023 Nov;25(11):3298-3306. doi: 10.1111/dom.15229. Epub 2023 Aug 8.

    PubMed 37551550

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SKF7® Labisia pumila standardized extract in people with Obesity, run by Medika Natura Sdn Bhd at 6 sites in Malaysia.

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 11 inclusion and 23 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 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Malaysia. 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?

Percentage of patients achieving more than or equal to 5% weight loss OR (time frame: Baseline Day 1 to Week 16). The study lists 2 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 NCT05851599, 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 9 May 2023.

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