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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005070
Enrollment
Unknown
Registered
2021-07-18
Start date
2021-08-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Acute gouty arthritis

Interventions

Sponsors

The First Teaching Hospital of Tianjin University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Total effective rate;

Secondary

MeasureTime frame
Laboratory 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;

Countries

China

Contacts

Public ContactLiu Wei

The First Teaching Hospital of Tianjin University of TCM

fengshiliuwei@163.com+86 13516161000

Outcome results

None listed

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