Skip to content

Study to Evaluate the Effect of "Differentiation of Cold and Heat Syndromes" Combined with Guideline-Directed Medical Treatment on the Quality of Life and Clinical Outcomes in Patients with Early Rheumatoid Arthritis: a Clinical Trial on Constructing a Novel Paradigm of Integrated Traditional Chinese and Western Medici

Study to Evaluate the Effect of "Differentiation of Cold and Heat Syndromes" Combined with Guideline-Directed Medical Treatment on the Quality of Life and Clinical Outcomes in Patients with Early Rheumatoid Arthritis: a Clinical Trial on Constructing a Novel Paradigm of Integrated Traditional Chinese and Western Medici

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063205
Enrollment
Unknown
Registered
2022-09-01
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rheumatoid arthritis

Interventions

treat group:Guizhi Shaoyao Zhimu Decoction + Methotrexate

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 16-70 years; 2. Meet the diagnostic criteria of ACR in 1987 or ACR/EULAR in 2010, with a course of disease <= 3 years; 3. Comply with the diagnostic criteria of TCM syndrome of cold-dampness obstruction or damp-heat obstruction in the "Traditional Chinese Medicine Diagnosis and Efficacy Criteria for Diseases and Syndrome"; 4. RA disease activity DAS28 <= 5.2; 5. Patients who did not receive treatment, or who only took methotrexate; 6. Voluntarily participate and sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with other rheumatism or severe pain caused by other diseases (such as diabetic pain or post-herpetic neuralgia); 2. Joint dysfunction, and the X-ray score of both wrists is grade IV; 3. Associated with mental and psychological disorders such as cognitive impairment, depression, anxiety, physical dysfunction, cerebral infarction, cerebral hemorrhage, epilepsy, TIA, myelitis, demyelinating disease and other central nervous system diseases, or restless legs syndrome Symptoms and other peripheral nerve diseases; 4. Organ transplant recipients, patients with malignant tumors, patients with heart, brain, liver (ALT/AST > 3 times the upper limit of normal), kidney (Cr < 60mL/min) and other important organ dysfunction or blood system diseases; 5. Pregnant or breastfeeding women or women and men who plan to become pregnant within the next 6 months; women of childbearing age who are unable or unwilling to take adequate contraception during the trial or within 1 month after the last dose or their spouses unwilling to take contraception measure; 6. Those who have participated in other clinical drug observations or are receiving other therapeutic drugs in the last 3 months; 7. Those who have adverse reactions to the ingredients of traditional Chinese medicine or methotrexate.

Design outcomes

Primary

MeasureTime frame
Disease Activity Score (DAS) 28;

Secondary

MeasureTime frame
FS-14 Fatigue Score;Pain Visual Analogue Scale Score;TCM Syndrome Score;

Countries

China

Contacts

Public ContactXu Yuan, Xiao Cheng

China-Japan Friendship Hospital

xuyuan2004020@163.com+86 13691548422

Outcome results

None listed

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