drugset / Trial / NCT02551575

Efficacy and Safety of Traditional Chinese Medicine (TCM) Comprehensive Therapy in Patients With Rheumatoid Arthritis

NCT02551575 ↗

RandomizedParallel-groupDouble-blindTreatment

Summary

This is prospective randomized, controlled study to evaluate the efficacy and safety of Qingre Huoxue comprehensive therapy in treating of patients with early Rheumatoid Arthritis (RA). The major outcome index is the change from baseline to week 24 in Disease Activity Score (DAS28), and minor outcome indexes include American College of Rheumatology (ACR)20/50/70, PRO score, Sharp score and OMERACT RAMRIS score. The adverse events at any time were recorded to evaluate the safety.

Timeline

Start
2014-11
Primary completion
2017-06
Completion
2017-12

Outcome

Met primary endpoint

paper DAS-28 decreased in all three groups after treatment (p < 0.0001); the score was lowest in the TCM group (p < 0.05) PMID 34113254 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydroxychloroquine Small molecule 200 mg Oral
Subject Methotrexate Small molecule 10 mg Oral
Subject Methotrexate Small molecule 15 mg Oral
Subject Qingre Huoxue external preparation Traditional medicine (herbal / TCM) 10 g Other
Subject Qingre Huoxue granule Unknown 10 g Oral

Indications