Efficacy, Safety, and Economic Evaluation of Gamidaeganghwal-Tang in Patients with Knee Osteoarthritis: Protocol for a Multicenter, Randomized, Double-Blind, Controlled Trial.

Researchers in South Korea are conducting a large study to test whether a traditional Korean herbal medicine called Gamidaeganghwal-tang (GMDGHT) can help people with knee osteoarthritis. Knee osteoarthritis is a common condition where the cartilage in the knee joint breaks down, causing pain, stiffness, and reduced quality of life. This herbal formula has been used for generations to treat joint problems, but solid scientific evidence has been lacking.

The study will involve 160 people aged 40-70 with knee osteoarthritis, split into two equal groups. One group will receive the actual herbal medicine, while the other receives a placebo (inactive treatment). Neither the participants nor the researchers will know who gets which treatment. Participants will take the medicine three times daily for 12 weeks, then be followed for another 12 weeks without treatment. Researchers will measure changes in pain, stiffness, physical function, and quality of life using standardized questionnaires. They'll also track any side effects and calculate whether the treatment is cost-effective.

This is a protocol paper, meaning the study is just beginning and no results are available yet. The researchers designed the study carefully to minimize bias and produce reliable evidence. If successful, this trial could provide scientific support for using GMDGHT as a treatment option for knee osteoarthritis. However, patients should note this study tests herbal medicine, not acupuncture specifically, though both fall under traditional Korean medicine. Anyone interested in traditional medicine approaches for knee osteoarthritis should consult with a qualified, licensed acupuncturist or herbalist who can provide individualized treatment recommendations.

This multicenter, randomized, double-blind, placebo-controlled trial protocol aims to evaluate the efficacy, safety, and cost-effectiveness of Gamidaeganghwal-tang (GMDGHT) for knee osteoarthritis. The study will enroll 160 participants (n=80 per group) aged 40-70 years with radiographic KOA (Kellgren-Lawrence grades I-III) and K-WOMAC scores ≥30. Participants will receive GMDGHT or placebo granules (10g TID) for 12 weeks with a 12-week follow-up period. The primary outcome is change in total K-WOMAC score from baseline to week 12. Secondary outcomes include 100-mm VAS pain scores, EQ-5D-5L quality of life measures, patient satisfaction, rescue medication use, and economic evaluation from societal and healthcare perspectives. Safety monitoring includes adverse event tracking and laboratory assessments at baseline and weeks 4, 8, 12, and 24. As this is a protocol paper, no efficacy or safety data are yet available. The rigorous methodology should provide high-quality evidence for GMDGHT's therapeutic potential in KOA management.