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Efficacy and safety of GyejigaChulBuTang(GCB) for knee pain in patients with Degenerative Knee Osteoarthritis : A multicenter, randomized, controlled, patient-assessor blind, clinical trial

Efficacy and safety of GyejigaChulBuTang(GCB) for knee pain in patients with Degenerative Knee Osteoarthritis : A multicenter, randomized, controlled, patient-assessor blind, clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0003024
Enrollment
80
Registered
2018-07-25
Start date
2018-08-01
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 : Treatment group : GyejigaChulBuTang(GCB), po-med, 3times/day 30min after meal, 1times 1shot(2.5g) total 3shot(7.5g), 28days medication Control group : Placebo(lactose, starch, caramel pigment),

Sponsors

Dunsan Korean Medicine Hospital of Daejeon University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients over 40 years old 2. A person who complains of more than VAS 30 mm of pain in his knee during his or her daily life. 3. Over grade 2 on Kellgren-Lawrence Grading Scale 4. A person who voluntarily decides to participate and agrees to the written agreement after having received a full explanation of the research objectives and processes

Exclusion criteria

Exclusion criteria: 1. Person with severe knee trauma in the last 6 months 2. Person with medical history of knee or planning for surgery within the research period 3. Person who received injection treatment such as steroids within 3 months and hyaluronic acid within 6 months 4. Person with a history of acupuncture, herbal acupuncture and herbal medicine for knee pain relief within the last month 5. Screening Clinical Examination ESR > 40 mmh, 1. RA Factor>20U/mL 6. Persons with musculoskeletal problems that cause more pain than knee pain in other body parts 7. If you have an uncontrolled heart condition such as angina, congestive heart failure, or if your blood test results in liver(AST, ALT levels are 40 Ul or higher), and the kidney function is abnormal(Creatine 0.5-0.9mg/dl, BUN 6-20mg/dl), systolic blood pressure is at least 180m mmg or greater than 100m mm even after two or three repeated measurements 8. People who are pregnant, nursing or diagnosed with malignant tumors 9. Galactose intolerance, lappase lactase deficiency, or glucose deficiency 10. A neuropsychiatrics who has significant history or is currently ill 11. Other members of the clinical research team think they are unsuitable

Design outcomes

Primary

MeasureTime frame
VAS

Secondary

MeasureTime frame
K-WOMAC;PGIC(Patient Global Impression of change);Adverse event

Countries

Korea, Republic of

Contacts

Public ContactEunseok Kim

Dunsan Korean Medicine Hospital of Daejeon University

mybestcando@naver.com+82-42-470-9140

Outcome results

None listed

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