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A 12-week, multi-organ, randomized, double-blind, placebo-controlled human application test to evaluate the effectiveness and safety of DKB-131 on knee arthritis

A 12-week, multi-organ, randomized, double-blind, placebo-controlled human application test to evaluate the effectiveness and safety of DKB-131 on knee arthritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008527
Enrollment
120
Registered
2023-06-16
Start date
2022-03-23
Completion date
Unknown
Last updated
2023-06-26

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 : Take four capsules of test food (1.5g/day as a powder of leprosy) once a day and once a day after eating

Sponsors

Dong Kook Pharm
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) men and women over 40 and under 80 years of age 2) A person whose Visual Analogue Scale (VAS) performed in Visit 1 and Visit 2 falls under 30 mm or more (knee area) 3) Those whose Kellgren & Lawrence Grade of the knee joint on X-ray corresponds to I and II 4) I agree to participate in this Human Application Test prior to the commencement of the Human Application Test, and I agree in writing

Exclusion criteria

Exclusion criteria: 1) The psychology of gravity, respiratory machinery, respiratory machinery, respiratory machinery, respiratory systems, neurological diseases, and malicious tumors, infectious diseases, and malicious tumors, infectious diseases 2) A person who corresponding to joint infectious arthritis by specific factors other than degenerative 3) mental illness such as mental illness, depression, drug addiction, drug addiction, alcohol use, alcohol usage, alcohol use, alcohol usage, alcohol usage 4) A person who has problems for human application test for human application test 5) In accordance with the visit 1st (90 days) within the joint of the joint of the visit 1st (90 days) 6) Based on the visit 1 month 30 days, health functional foods or joint health functions within one month 30 days 30 days 7) According to the visit 1st reference to the visit or maintenance system within two weeks, and non-steeloiditis (a-Nanool, Trama Dolphinitis) and non-steeloid arthritis 8) As of visiting 1 month (90 days) took a low amount of aspirin 100 mg) within 3 months (90 days) 9) As of visiting 1st, a physical treatment or a method for treating degenerative arthritis within two weeks 10) A high blood pressure patient (water blood pressure 160 mmHg or relaxation pressure 100 mmHg or relax blood pressure 100 mmHg or relaxation test subjects) 11) diabetes patient (HbA1c is not controlled by 7.0 %) 12) or ALT (GPT) or ALT (GPT) is 3 times more than 3 times 13) A fineine is more than 2 times of the normal upper upper upper upper upper upper upper upper upper upper limit 14) If you participated in a month, participated in other arbitration clinical trials (including an entity application test (including an entity application test) or participation test (including human application test) 15) who are pregnant or pregnant women who are pregnant or pregnant women's applications during the test period 16) Anyone who is sensitive or allergic to this human application test 17) judging that the test is inappropriate for other reasons

Design outcomes

Primary

MeasureTime frame
Total K-WOMAC score and change in each item score

Secondary

MeasureTime frame
Variation in VAS;Change in SF-36;Self-evaluation of the improvement of the human body application tester;Self-evaluation of the improvement of human body application test subjects;Changes in ESR and CRP

Countries

Korea, Republic of

Contacts

Public ContactJeong Ku Ha

Inje University

revo94@hanmail.net+82-2-2270-0025

Outcome results

None listed

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