A human study to evaluate the efficacy and safety of extracts of Ficus erecta var. sieboldii King Leaves on arthritis : a randomized, double-blind, placebo-controlled study

Not Applicable

Completed

• Conditions: Diseases of the musculo-skeletal system and connective tissue

• Registration Number: KCT0002613
• Lead Sponsor: Jeju Technopark

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1) Subject who voluntarily agree to participate and signs informed consent form
2) Age = 50 years
3) Subject who suffers from osteoarthritis

Exclusion Criteria

1) Subjects with Kellgren-Lawrence grade 3 or 4
2) Subjects who intakes medication of nonsteroidal anti-inflammatory drug (NSAID) within 1 week prior to the first visit
3) Inflammatory osteoarthritis (increase of ESR(erythrocyte sedimentation rate) or CRP(C-reactive protein))
4) High obesity (BMI = 30)
5) Other nervous system or lower limb abnormality such as hip joint or foot joint that can disturb gait
6) More than moderate degree of back pain or radiating pain in lower limbs
7) Severe neurological and vascular disorders in lower limbs
8) Continuous consumption of health functional food (glucosamine, MSM) that affect osteoarthritis within 4 weeks before the first visit
9) Hypersensitivity to test materials
10) Pregnant or lactating women
11) Participation in another clinical trial within 4 weeks prior to the study
12) Any other disease affecting the results of the study

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual analogue scale;Western Ontario and McMaster University Osteoarthritis Index

Secondary Outcome Measures

Name	Time	Method
Radiographic assessment;Biomarker in blood and urine;Clinical pathology analysis (blood, urine)