Dose-Ranging Study of SKF7® for Obesity

NCT ID: NCT05851599

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-12
• Study Completion Date: 2021-08-08

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SKF7® - 375 mg

Patients who meet the entry criteria for the study will be randomized to receive 375 mg SKF7® for 16 weeks

Group Type: EXPERIMENTAL

SKF7® Labisia pumila standardized extract

Intervention Type: OTHER

Botanical extract of Labisia pumila (Kacip Fatimah)

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

Group Type: EXPERIMENTAL

SKF7® Labisia pumila standardized extract

Intervention Type: OTHER

Botanical extract of Labisia pumila (Kacip Fatimah)

SKF7® - 750 mg

Patients who meet the entry criteria for the study will be randomised to receive 750 mg SKF7® for 16 weeks

Group Type: EXPERIMENTAL

SKF7® Labisia pumila standardized extract

Intervention Type: OTHER

Botanical extract of Labisia pumila (Kacip Fatimah)

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

SKF7® Labisia pumila standardized extract

Intervention Type: OTHER

Botanical extract of Labisia pumila (Kacip Fatimah)

Interventions

SKF7® Labisia pumila standardized extract

Botanical extract of Labisia pumila (Kacip Fatimah)

Intervention Type: OTHER

Other Intervention Names

SKF7®

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zach Biotech Depot Sdn Bhd

UNKNOWN

Sponsor Role: collaborator

Medika Natura Sdn Bhd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shalini Vijayasingham, MBBS, MRCPS

Role: PRINCIPAL_INVESTIGATOR

Hospital Melaka, Malaysia

Locations

Klinik Kesihatan Greentown

Ipoh, , Malaysia

Klinik Kesihatan Kuang

Kuang, , Malaysia

Hospital Melaka

Malacca, , Malaysia

Klinik Kesihatan Masjid Tanah

Malacca, , Malaysia

Hospital Tuanku Jaafar

Seremban, , Malaysia

Klinik Kesihatan Seremban 2

Seremban, , Malaysia

Countries

Malaysia

References

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.

Reference Type: DERIVED

PMID: 37551550 (View on PubMed)

Other Identifiers

CRSU-P-1-1019

Identifier Type: -

Identifier Source: org_study_id