Skip to content

12week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of BST106 on Osteoarthritis

12week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of BST106 on Osteoarthritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0004238
Enrollment
80
Registered
2019-08-26
Start date
2018-02-26
Completion date
Unknown
Last updated
2020-12-02

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 Chrysanthem

Sponsors

Inje University Seoul Paik Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult male and female between 40 years and 75 years Patients diagnosed more than 30mm in VAS (Visual analogue scale) Patients diagnosed grade I, II 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 diagnosed with arthritis by specific factors othre than degenerative arthritis (2) Joint spacing less than 2mm (3) Subjects who are judged to have severe arthritis with bony spur, irregular articular surface and osteocystoma etc (4) Subjects with clinically significant cardiovascilar, immune, infectious and neoplastic diseases (5) Patients undergoing gastritis and gastric ulcers (6) Subjects with resistant hypertension (Upper than 160/100mmHg, After 10 minutes rest) (7) Subjects with resistant diabetes (Fasting glucose levels upper than 180mg/dl) (8) TSH lower than 0.1µIU/ml or upper than 10 µIU/ml (9) AST(GOT) and ALT(GPT) is at least 3 timesthe normal range (10) Creatinine is at least twice the normal range (11) Pregnant or nursing women (12) Subjects who is on a diet Health Functional Foods and medicine to improve joint/cartilage health (13) Subjects who are treated with mental disorders such as depression and schizophrenia. (14) Oriental medicine treatment of acupuncture, moxibustion, cupping therapy, herbal medicine, etc. within 2 month prior to the study (15) Participation in anothrt clinical trial within 2 month prior to the study (16) Hypersensitivity or allergy to the test materials (17) Participation who are judged to be unable to comply with the requirements of the test

Design outcomes

Primary

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

Secondary

MeasureTime frame
VAS (Visual analogue scale) and KSF-36 (Korean-short form health survey 36)

Countries

Korea, Republic of

Contacts

Public ContactYunyoung KIM

Inje University Seoul Paik Hospital

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026