The difference of rheumatoid arthritis cold and heat syndrome and the clinical study on the intervention of modified Guizhi Fuzi Decoction on cold syndrome

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300067710

Enrollment

Unknown

Registered

2023-01-18

Start date

2022-07-04

Completion date

Unknown

Last updated

2023-05-15

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

Conditions

Rheumatoid Arthritis

Interventions

experimental group:Jiawei Guizhi Fuzi Decoction Granules + Methotrexate Tablets + Folic Acid Tablets

control group:Modified Guizhi Fuzi Decoction Simulant + Methotrexate Tablets + Folic Acid Tablets

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years, gender unlimited; 2. Meet the diagnostic criteria of RA in Western Medicine, the diagnostic criteria for wind-cold-damp-arthralgia syndrome and damp-heat arthralgia syndrome in Traditional Chinese Medicine; 3. Gender, age, ethnic and geographically matched healthy volunteers; 4. Those who voluntarily participate in the study and agree to sign the informed consent for entering the clinical study.

Exclusion criteria

Exclusion criteria: 1. Severe joint deformity joint function in patients with late ? level,and X-ray staging in ? level, above symptom severity classification of severe patients; 2. Patients with other rheumatic diseases, such as systemic lupus erythematosus, Sjogren's syndrome, severe knee osteoarthritis, etc; 3. Patients with heart, brain, liver, kidney, hematopoietic system and other serious primary diseases; 4. Pregnant or lactating women, mental patients; 5. Allergic; 6. Participating in other drug clinical trials.

Design outcomes

Primary

Measure	Time frame
TCM syndrome score;DAS28 score;Erythrocyte sedimentation rate;C-reactive protein;	—

Secondary

Measure	Time frame
Joint swelling number;Number of joint tenderness;Subject's Global Assessment of Disease Activity (PtGA);Subject Pain Visual Analog Scale (VAS);Investigator's Global Assessment of Disease Activity (PrGA);Anti-cyclic citrullinated peptide antibody;Curative effect of TCM diseases;Health Assessment Questionnaire (HAQ);Color Doppler examination of wrist joint and its surrounding soft tissue;X-ray examination of hand;	—

Measure

Time frame

Joint swelling number;Number of joint tenderness;Subject's Global Assessment of Disease Activity (PtGA);Subject Pain Visual Analog Scale (VAS);Investigator's Global Assessment of Disease Activity (PrGA);Anti-cyclic citrullinated peptide antibody;Curative effect of TCM diseases;Health Assessment Questionnaire (HAQ);Color Doppler examination of wrist joint and its surrounding soft tissue;X-ray examination of hand;

—

Countries

China

Contacts

Public ContactTang Xiaohu

Yunnan Traditional Chinese Medicine Hospital

h.tang0718@163.com+86 13064214246

Outcome results

None listed

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