NCT06309030

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Liu Longxiao · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In this study, a randomized, double-blind, placebo-controlled clinical research methodology was proposed using computerized SPSS software to randomize the group to include 72 cases of RA patients who had been treated regularly with traditional RA disease-improving antirheumatic drugs for more than 3 months and whose disease was still at a low level of disease activity. On the basis of RA traditional condition-improving antirheumatic drug treatment, the treatment group was given Inib soup to tonify the kidney, dispel cold and cure the inibs, and the control group was given an analog of Inib soup to tonify the kidney, dispel cold and cure the inibs, with a 12-week treatment period and a 4-week follow-up period, in order to observe the efficacy and safety of the inibs based on the tonifying the kidney, dispel cold and cure the inibs on the clinical depth of relief of RA pain, and to assess the DAS-28, the VAS score of pain, the mechanical pain threshold, and laboratory laboratory laboratory tests (blood and urine routine, liver and renal function, ESR, CRP, RF, ACPA), electrocardiogram, compare the differences between the two groups in each of the above indexes and conduct correlation analysis, so as to provide evidence-based medical evidence for clinical practice. Based on clinical practice, explore the effect of tonifying the kidney, dispelling cold and curing Inibs to improve the clinical remission of RA, and provide a new strategy for the standardized treatment and clinical remission of RA. Using a combination of pain VAS scores and objective mechanical pain threshold measurements, we evaluated the effect of tonifying the kidneys, dispelling cold, and curing inibs on the pain relief of RA patients with kidney deficiency and cold-sheng syndrome, and provided references for the relief of RA pain.

Conditions

• Rheumatoid Arthritis

Interventions

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

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-12-31
• Completion: 2026-08-01
• First posted: 2024-03-13
• Last updated: 2024-03-13