Randomized parallel controlled clinical trial of Qinpi Tongfeng decoction combined with bloodletting in the treatment of acute gouty arthritis (damp heat accumulation syndrome)

Phase 1

Recruiting

• Conditions: Acute gouty arthritis

• Registration Number: ITMCTR2100005070
• Lead Sponsor: The First Teaching Hospital of Tianjin University of TCM

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. Accord with the diagnostic standard of Western medicine for acute gouty arthritis;
2. Accord with the diagnostic standard of dampness heat accumulation syndrome of gout;
3. The patient's disease was within 72 hours of acute gouty arthritis attack;
4. The patient had gout at least once;
5. Patients also need to have moderate, severe or extreme joint pain, using pain digital assessment scale score >= 4 points;
6. Those who did not take other drugs for gouty arthritis within 72 hours before entering the group;
7. Those who have not taken the anti uric acid drugs in recent 2 weeks;
8. Aged from 18 to 70 years;
9. The subjects agreed to join the study and signed the informed consent.

Exclusion Criteria

1. Secondary gouty arthritis caused by renal failure, tumor chemotherapy or radiotherapy, drugs, etc;
2. Patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, knee osteoarthritis and other inflammatory arthritis diseases;
3. The patient had multi joint gout (> 4 joints);
4. Patients with severe primary diseases such as cardiovascular, cerebrovascular, pulmonary, renal, endocrine and hematopoietic systems;
5. Alt, AST or Cr were more than 1.5 times ULN (upper limit of normal value);
6. Allergic to the components of the test drug;
7. Patients with asthma, urticaria or allergic reaction induced by taking aspirin or other non steroidal anti-inflammatory drugs;
8. Pregnant, pregnant or lactating women;
9. Patients with active peptic ulcer or bleeding, or patients with peptic ulcer or bleeding in the past;
10. Those who have participated in or are participating in other clinical trials in recent one month;
11. Mental illness, no insight, unable to express exactly or take medicine on time, unable to cooperate with the completion of the trial.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Total effective rate;

Secondary Outcome Measures

Name	Time	Method
aboratory index;Complete pain relief time;Changes of pain digital assessment scale scores after the first treatment;TCM syndrome score;Pain digital assessment scale score;Joint symptom score;