A Randomized, Double-blind and Controlled Clinical Trial for Baihu Jiaguizhi Decoction in the Treatment of Acute Gouty Arthritis

Phase 1

Recruiting

• Conditions: gout

• Registration Number: ITMCTR1900002506
• Lead Sponsor: Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Adult subjects with a diagnosis of gout and with TCM diagnosis of damp-heat obstruction syndrome;
2. Male and female patients aged 18-65 years with independent behavior ability;
3. Within 48 hours of acute attack, no other similar treatment was given within 14 days before the trial;
4. eGFR>=30ml/min/1.73m2;
5. Patients must sign informed consent to enter clinical research.

Exclusion Criteria

1) Patients do not meet the above inclusion criteria;
2) Female patients during pregnancy or lactation;
3) Patients are allergic to drug allergy of this subject or individual hypersensitivity;
4) The level of ALT was higher than 2 times normal;
5) Patients with serious primary diseases such as heart, liver, kidney, brain, endocrine system,hematopoietic system or mental illness;
6) Patients with severe joint deformity or even labor loss ;
7) Patients received the same treatment within 2 weeks before the trial;
8) Patients have the poor compliance to difficult to complete the clinical observer.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
interleukin-10;NACHT, LRR and PYD domains-containing protein 3;interleukin-6;Visual analog scale test;cysteinyl aspartate specific proteinase-1;Evaluation of joint tenderness;tumor necrosis factor-a;C-reactive protein;NF-?B;Ultrasound Imaging Score;Evaluation of joint swelling;Erythrocyte sedimentation rate;Evaluation of joint activity;blood uric acid;interleukin-1ß;

Secondary Outcome Measures

Name	Time	Method
the total of urine uric acid in 24-hours;Serum xanthine oxidase;TCM syndrome curative effect ratings;