A 12 week, Multi-center, Stratified Randomized, Double-blind, Placebo-Controlled Clinical Trial for the evaluation of the efficacy and safety og GCWB106 on knee osteoarthritis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005701

Enrollment

Registered

2020-12-24

Start date

2020-12-11

Completion date

Unknown

Last updated

2024-12-09

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 : Treatment group: 1 tablet, once a day (250 mg as Chrysanthemum zawadskii Herbich var. latilobum (Maxim.) Kitamura extract) Control group: 1 tablet, once a day (0 mg as Chrysanthe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult male and female between 40 years and 80 years Patients diagnosed more than 30mm in VAS (Visual analogue scale) Patients diagnosed grade 2, 3 with kellgren & Lawrence grading scale in X-ray Those who agree to the written consent of the applicant and who can cooperate with the necessary visits and related tests and surveys for the study process

Exclusion criteria

Exclusion criteria: (1) Subjects with clinically significant cardiovascilar, immune, infectious and neoplastic diseases (2) Subjects diagnosed with arthritis by specific factors othre than degenerative arthritis (3) Subjects who is on a diet Health Functional Foods and medicine to improve joint/cartilage health (4) Oriental medicine treatment of acupuncture, moxibustion, cupping therapy, herbal medicine, etc. within 2 month prior to the study (5) Subjects with resistant hypertension (Upper than 160/100mmHg, After 10 minutes rest) (6) Subjects with resistant diabetes (Fasting glucose levels upper than 180mg/dl) (7) TSH lower than 0.1µIU/ml or upper than 10 µIU/ml (8) AST(GOT) and ALT(GPT) is at least 3 timesthe normal range (9) Creatinine is at least twice the normal range (10) Participation in anothrt clinical trial within 2 month prior to the study (11) Pregnant or nursing women (12) Hypersensitivity or allergy to the test materials (13) Participation who are judged to be unable to comply with the requirements of the test

Design outcomes

Primary

Measure	Time frame
VAS (Visual analogue scale)	—

Secondary

Measure	Time frame
Total score of K-WOMAC (The western ontario and McMaster university osteoarthritis index)	—

Countries

Korea, Republic of

Contacts

Public ContactYunyoung KIM

Inje University Seoul Paik Hospital

Outcome results