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Efficacy Study of Si Miao San in the Treatment of Acute Gouty Arthritis with Damp-Heat Toxin Accumulation Pattern based on Circadian Rhythm Evaluation

Efficacy Study of Si Miao San in the Treatment of Acute Gouty Arthritis with Damp-Heat Toxin Accumulation Pattern based on Circadian Rhythm Evaluation

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086888
Enrollment
Unknown
Registered
2024-07-15
Start date
2024-07-15
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Acute Gouty Arthritis

Interventions

Control Group:Adherence to a diet low in salt, sugar, fat, and purine was necessary, as well as the prevention of infections and maintenance of water, electrolyte, and acid-base balance. Participants
Experimental group:Adherence to a diet low in salt, sugar, fat, and purine was necessary, as well as the prevention of infections and maintenance of water, electrolyte, and acid-base balance. Particip

Sponsors

Shuguang Hospital affiliated to Shanghai University of T.C.M
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Only those who meet all the following requirements can be included in this trial. 1)In accordance with the 2015 gout diagnostic criteria established by the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR), and based on the "Guidelines for Integrated Traditional Chinese and Western Medicine in the Diagnosis and Treatment of Gout and Hyperuricemia (2023)," the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine," and the "Guiding Principles for Clinical Research of New Chinese Medicines," the diagnosis aligns with traditional Chinese medicine diagnoses of "gout" and "damp-heat toxin accumulation syndrome," and the stage is classified as acute gouty arthritis. 2)Traditional Chinese medicine distinguishes it as the syndrome of damp-heat and toxin accumulation; 3)Age is between 18 and 60 years old, regardless of gender; 4)Voluntarily participate in clinical research and sign an informed consent form.

Exclusion criteria

Exclusion criteria: Individuals with any of the following conditions will be excluded from this study: 1)Known allergies to the trial drug; 2)Undergoing dialysis treatment; 3)Concurrent hyperkalemia, heart failure, uremia, or other life-threatening conditions; 4)Primary disease being obstructive nephropathy; 5)Mental illness; 6)Pregnant or lactating women; 7)Coexistence of serious primary diseases in the brain, cardiovascular system, liver or hematopoietic system; 8)Undergone major or medium surgery within 3 months prior to the screening examination; 9)Have taken other anti-inflammatory and analgesic drugs (non-steroidal anti-inflammatory drugs, colchicine, and corticosteroids) within 2 weeks before the treatment; 10)Have taken other trial drugs or participating in other clinical studies within 1 month prior to inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Joint Pain Rating;

Secondary

MeasureTime frame
Joint Swelling Rating;Joint Function Rating;Quantitative Score of Traditional Chinese Medicine (TCM) Syndrome;Serum C-reactive Protein;Erythrocyte Sedimentation Rate;Serum Uric Acid;Musculoskeletal Ultrasound Indices;IL-1;IL-6;TNF-a;

Countries

China

Contacts

Public ContactYao, Jinghui

Shuguang Hospital affiliated to Shanghai University of T.C.M

zhydyjh@163.com+86 135 6436 9214

Outcome results

None listed

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