Clinical Study on the Deep Remission of Rheumatoid Arthritis With Kidney Deficiency and Excessive Cold Syndrome by Bushen Quhan Zhiwang Decoction

NCT06309030 | Not Yet Recruiting

• 1 other identifier: ZRJY2023-QM21
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators conduct this randomized controlled clinical trial to evaluate the efficacy and safety of the Bushen Quhan Zhiwang decoction in patients with RA with kidney deficiency and excessive cold syndrome who have not achieved deep remission and remained at a low level of disease activity despite the use of conventional synthetic disease-modifying antirheumatic drugs.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• disease activity score derivative for 28 joints (DAS28)

  DAS28 (CRP) = 0.56\*√(TJC28) +0.28\*√(SJC28)+0.014\*GH+0.36\*ln(CRP+1)+0.96; DAS28 (ESR) = 0.56\*√(TJC28)+0.28\*√(SJC28)+0.014\*GH+0.70\*ln(ESR), where TJC = tender joint count and SJC = swollen joint count.

  Enrolment, 4 weeks, 8 weeks,12 weeks and 16 weeks after intervention.

Secondary Outcomes (6)

• patient reported outcomes（PRO）

  Enrolment, 4 weeks, 8 weeks,12 weeks and 16 weeks after intervention.

• visual analogue scale for pain

  Enrolment, 4 weeks, 8 weeks,12 weeks and 16 weeks after intervention.

• withdrawl mechanical threshold

  Enrolment, 4 weeks, 8 weeks,12 weeks and 16 weeks after intervention.

• erythrocyte sedimentation Rate（ESR）

  Enrolment, 4 weeks,12 weeks after intervention.

• C-reactive protein（CRP）

  Enrolment, 4 weeks,12 weeks after intervention.

Study Arms (2)

Intervention group

EXPERIMENTAL

Drug: Bushen quhan zhiwang decoction

Control group

PLACEBO COMPARATOR

Drug: Bushen quhan zhiwang decoction placebo

Interventions

Bushen quhan zhiwang decoction DRUG

Treatment with 100ml of Bushen quhan zhiwang decoction twice a day for 3 months.

Intervention group

Bushen quhan zhiwang decoction placebo DRUG

Treatment with 100ml of Bushen quhan zhiwang decoction placebo twice a day for 3 months.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients meeting the ACR/European League against Rheumatism (EULAR) 2010 classification criteria；
• Patients meeting the diagnostic crite ria (2018 edition) for "kidney deficiency and excessive cold syndrome" in Chinese medicine；
• The disease activity score derivative for 28 joints (DAS28) score should be 2.6 to 3.2；
• Use of traditional disease-modifying antirheumatic drugs (DMARDs), tretinoin preparations, etc., limited to 1 type and have been treated at a stable dose for at least 4 weeks prior to enrollment, and the dose of the medication remains unchanged after enrollment；
• For those taking oral glucocorticosteroids prior to enrollment, the dose must be stabilized to a dose equivalent to ≤10 mg/day of prednisone for at least 4 weeks prior to enrollment and remain unchanged after enrollment；
• Those using non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesics for RA must have been on a stable dose for at least 1 week prior to enrollment and the dose of medication must remain unchanged after enrollment；
• Voluntary participation and written informed consent.

You may not qualify if:

• Previously treated with small molecule targeted drugs or biologics and discontinued for \<4 weeks；
• Those who have been treated with intra-articular, intramuscular or intravenous corticosteroids, including pro-adrenal hormones, within 4 weeks prior to enrollment；
• Those with a combination of clearly diagnosed autoimmune diseases such as systemic lupus erythematosus, scleroderma, Sjogrensyndrome, etc.；
• Organ transplant recipients, patients with malignant tumors, patients with heart, brain, liver (ALT/AST\>3 times the upper limit of normal), kidney (Ccr\<60ml/min) and other important organ function damage or blood system diseases；
• With psychosomatic disorders such as cognitive impairment, depression, anxiety, and somatic dysfunction, central nervous disorders such as cerebral infarction, cerebral hemorrhage, epilepsy, TIA, myelitis, demyelinating lesions, or peripheral neurological disorders such as restless leg syndrome；
• Women and men who are pregnant or breastfeeding or who plan to become pregnant in the next 6 months; women of childbearing age who are unable or unwilling to use adequate contraception or whose partners are unwilling to use contraception, either during the trial period or within 1 month after the last dose of medication；
• BMI greater than 35 (kg/m2), allergic to the test drug, or participating in other clinical trials；
• Other conditions deemed by the investigator to make participation in the trial unsuitable (out-of-town patients unable to follow up, etc.).

Sponsors & Collaborators

• Liu Longxiao: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 13, 2024
• Study Start: April 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 13, 2024

Record last verified: 2024-03