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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002613

Enrollment

Registered

2017-12-26

Start date

2017-03-17

Completion date

Unknown

Last updated

2021-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Consumption of extracts of Ficus erecta var. sieboldii King Leaves or placebo for 12 weeks (100mg/tablet of extracts of Ficus erecta var. sieboldii King Leaves/5 tablet a day )

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Visual analogue scale;Western Ontario and McMaster University Osteoarthritis Index	—

Secondary

Measure	Time frame
Radiographic assessment;Biomarker in blood and urine;Clinical pathology analysis (blood, urine)	—

Countries

Korea, Republic of

Contacts

Public ContactEunok Lee

Ewha Womans University

Outcome results