Dose-Ranging Study of SKF7® for Obesity

NCT05851599 | Completed Phase 2

• 1 other identifier: CRSU-P-1-1019
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 6

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• 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

  Baseline Day 1 to Week 16

• 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

  Baseline Day 1 to Week 16

Secondary Outcomes (6)

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

  Baseline Day 1 to Week 16

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

  Baseline Day 1 to Week 16

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

  Baseline Day 1 to Week 16

• Percentage change from baseline in BMI at week 16

  Baseline Day 1 to Week 16

• Change in blood lipid concentrations.

  Baseline Day 1 to Week 16

Study Arms (4)

SKF7® - 375 mg

EXPERIMENTAL

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

SKF7® - 562.5 mg

EXPERIMENTAL

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

SKF7® - 750 mg

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo

Other: SKF7® Labisia pumila standardized extract

Interventions

SKF7® Labisia pumila standardized extract OTHER

Botanical extract of Labisia pumila (Kacip Fatimah)

Also known as: SKF7®

Placebo; SKF7® - 375 mg; SKF7® - 562.5 mg; SKF7® - 750 mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Medika Natura Sdn Bhd: lead
• Zach Biotech Depot Sdn Bhd: collaborator

Study Sites (6)

Klinik Kesihatan Greentown

Ipoh, Malaysia

Location

Klinik Kesihatan Kuang

Kuang, Malaysia

Location

Hospital Melaka

Malacca, Malaysia

Location

Klinik Kesihatan Masjid Tanah

Malacca, Malaysia

Location

Hospital Tuanku Jaafar

Seremban, Malaysia

Location

Klinik Kesihatan Seremban 2

Seremban, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 37551550 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shalini Vijayasingham, MBBS, MRCPS

  Hospital Melaka, Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: May 9, 2023
• Study Start: October 12, 2020
• Primary Completion: August 8, 2021
• Study Completion: August 8, 2021
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (6)