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Clinical Efficacy and Mechanism Study of Qihuatongtiao Formula in the Treatment of Hyperuricemia

Clinical Efficacy and Mechanism Study of Qihuatongtiao Formula in the Treatment of Hyperuricemia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001250
Enrollment
Unknown
Registered
2025-06-23
Start date
2024-12-03
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Hyperuricemia

Interventions

1:Non-drug therapy (dietary therapy, behavioral intervention) + Qihuatongtiao Formula granule (Astragalus membranaceus 6g, Bupleurum chinense 3g, Atractylodes macrocephala 9.23g, Polyporus umbellatus
2: Non-drug therapy (dietary therapy behavioral intervention) + Optimized Qihuatongtiao Formula granule (Astragalus membranaceus 9g Citrus aurantium 6.75g Poria cocos 1.8g Angelica sinensis 15g) 1 dos
3:Non-drug therapy (dietary therapy behavioral intervention) course of treatment: 8 weeks

Sponsors

Institute of Basic Theory of Chinese Medicine China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Here is the translation of the provided criteria into English: 1. Age between 18 and 65 years, with no gender restrictions; 2. Meet the aforementioned diagnostic criteria for the asymptomatic phase of HUA; 3. Meet the aforementioned traditional Chinese medicine diagnostic criteria for dampness and turbidity syndrome in HUA; 4. Have not taken antibiotics or immunosuppressants in the past 3 months, and have not participated in any clinical studies; 5. Voluntarily participate in this trial, understand the content and requirements of the trial, and have signed the informed consent form; 6. Have not yet received HUA treatment, or have received other HUA treatments but have undergone a washout period of more than 2 weeks; 7. Serum uric acid (SUA) levels reach the starting point for drug intervention and are less than 600 µmol/L.

Exclusion criteria

Exclusion criteria: Here is the translation of the provided exclusion criteria into English: 1. Those with comorbid kidney diseases (such as chronic urate nephropathy, uric acid nephrolithiasis, chronic kidney disease, acute kidney injury, etc., and eGFR = 60 mL/(min·1.73m²)), cardiovascular diseases (such as hypertension, coronary heart disease, heart failure, etc.), neurological diseases (stroke, neurodegenerative diseases, etc.), liver diseases (including abnormal liver function, with ALT, AST exceeding the upper limit of the normal range by more than 1.5 times), lung diseases, hematopoietic system diseases, and malignant tumors, severe infections, and other serious diseases; 2. Those who have entered the symptomatic phase of gout; 3. Those with incomplete required test indicators; 4. Those who have participated in other clinical trials within the last month and may affect this trial; 5. Those who are allergic to the components of the trial medication; 6. Those who are pregnant or breastfeeding, or women who plan to become pregnant in the near future; 7. Those who have taken medications that increase or decrease blood uric acid levels within the last month, or have received other treatments that may affect the efficacy indicators of this study (such as cardiovascular disease patients who are using or must use diuretics, aspirin, etc., affecting SUA medications, or those who have taken other types of urate-lowering drugs and dampness-dispelling and turbidity-reducing traditional Chinese medicines like allopurinol, benzbromarone within the last month); 8. Those who are unable to cooperate, such as patients with mental illnesses; 9. Those who are alcoholics or drug users; 10. Other situations deemed unsuitable by the investigator.

Design outcomes

Primary

MeasureTime frame
serum uric acid;Intestinal flora;TCM Syndrome Score;

Secondary

MeasureTime frame
Electrocardiogram (ECG);Blood Lipids (HDL-C LDL-C etc.);SF-36 Health Questionnaire;Urine Routine;Liver and Kidney Function (ALT Scr);Blood Routine;Blood Pressure Measurement;Physical Examination (Weight WC etc.);Body Fluid Distribution Measurement;

Countries

China

Contacts

Public ContactYang Jinsheng

China Academy of Chinese Medical Sciences

zml@ibucm.com17795603981

Outcome results

None listed

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