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Clinical research on the efficacy and safety of Gyebutang Granule combined with acupuncture on knee osteoarthritis

Clinical research on the efficacy and safety of Gyebutang Granule combined with acupuncture on knee osteoarthritis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0003264
Enrollment
100
Registered
2018-10-15
Start date
2018-10-11
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

Drug : The Experimental group take Gyebutang Granule 3.75g twice a day for 6 weeks by oral intake. And the control group do Celecoxib 100mg 1 capsule twice a day for 6 weeks by it. In addition, both

Sponsors

Semyung University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adults aged 40 to 69 years. 2. Those who follow the American College of Rheumatology (ACR) classification criteria for osteoarthritis of the knee and satisfy both ? and ? below. ? During the last 6 months, unilateral or bilateral knee arthritic pain has been reported during weight bearing activity. ? The knee arthritic pain is shown more than 40 ? on 100 ? Visual Analog Scale (VAS) 3. Those who decide to voluntarily participate in this clinical trial and agree in signing informed consent. 4. A person who is trusted and willing to cooperate with this trial for the next three months

Exclusion criteria

Exclusion criteria: 1. A history of knee trauma within the last 6 months. 2. Operation history for the knee within the last 6 months. 3. Intra-articular injections (steroids, mucus supplements, etc.) within the last 3 months. 4. The physical and diagnostic examination indicate an inflammatory arthritis such as rheumatoid arthritis, infectious disease or autoimmune disease. 5. Those who are treated with mental disorders such as depression and schizophrenia. 6. Patients with liver disease (AST or ALT > normal range 2 times) 7. Patients with renal disease (serum creatinine > 2.0 ? / ?) 8. Those who have other diseases that may interfere with treatment, such as serious gastrointestinal diseases, cardiovascular diseases, hypertension, diabetes, kidney disease, liver disease, thyroid dysfunction etc. 9. Those who take restrictive disease, contraindication, hypersensitivity in using the prescription of non-steroidal anti-inflammatory drugs (NSAIDs). 10. Pregnant and lactating women. 11. If the researcher judge the subject is not suitable for enrolling trial. 12. Those who participated in other clinical trials within last 4 weeks or are currently participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
100 mm Pain VAS (Vas Analogue Scale)

Secondary

MeasureTime frame
K- WOMAC (Westren Ontario and McMaster Universities) Scale, subscale;Pain Numeral Rating Scale (NRS);EuroQoL-5D-5L;Patient global assessments (PGA);Adverse event

Countries

Korea, Republic of

Contacts

Public ContactCham Kyul Lee

Semyung University

leetaeho0331@hanmail.net+82-43-841-1738

Outcome results

None listed

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