Efficacy and Safety of Fermented Achyranthes japonica NAKAI Extract Powder on degenerative arthritis; A 12week, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001958

Enrollment

Registered

2016-07-01

Start date

2016-05-02

Completion date

Unknown

Last updated

2019-03-11

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 : Subjects will be randomized to receive Fermented Achyranthes japonica NAKAI Extract Powder 500mg or placebo. Subjects will orally self-adminster Fermented Achyranthes japonica NAK

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) All men and women aged between 40 and 75 year (2) VAS(Visual Analogue Scale) = 30mm (3) Kellgren-Lawrence Grade ? to ? confirmed radiologically (4) Subject who agrees to participate in the study and signs the informed consent form

Exclusion criteria

Exclusion criteria: (1) Arthritis caused by other factors (Non-degenerative arthritis) (2) Joint space narrowing (more than 2mm) (3) Radiographic finding in moderate arthritis include marginal osteophyte formation, irregular joint margin, subchondral bone cyst (4) Include clinically significant cardiovascular disease or immune disease or inflammatory disease or tumor disease (5) Subject who complain gastrointestinal symptoms such as gastritis, gastric ulcer (6) Subject with uncontrolled hypertension (over 170/100mmHg, when measuring after 10 minutes steady) (7) Subject with uncontrolled diabetes mellitus (more than 180mg/dl of fasting glucose) (8) Subject with TSH =0.1uU/ml or = 10 uU/ml (9) Subject with AST(GOT) or ALT(GPT) or ?-GTP = 3 times the upper limit of normal (10) Subject with serum creatinine = 2 times the upper limit of normal (11) Subject who is pregnant or lactating, or plans to become pregnant within 3 months (12) Subject who has taken medicines, health functional foods within 1 weeks for improvement of arthritis (13) Subject with mental disorders such as schizophrenia, depressive disorder, drug intoxication (14) Subject who participated in any clinical trial within 3 month or plan to participate in the other clinical study (15) Inappropriate subject decided by the investigator

Design outcomes

Primary

Measure	Time frame
Visual analogue scale	—

Secondary

Measure	Time frame
Korean-Short Form Health Survey 36;Korean-Western Ontario and McMaster University Osteoarthritis Index;generalized evaluation of physician;generalized evaluation of patient;CRP(C-Reactive Protein), ESR(Erythrocyte Sedimentation Rate)	—

Countries

Korea, Republic of

Contacts

Public ContactSaebyeol Shin

Konkuk University Medical Center

Outcome results