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Randomized, controlled, double-blind, multicenter, prospective clinical study and mechanism exploration of Qinggan Sanjie Xiaoying Decoction in treating Hashimoto's thyroiditis

Randomized, controlled, double-blind, multicenter, prospective clinical study and mechanism exploration of Qinggan Sanjie Xiaoying Decoction in treating Hashimoto's thyroiditis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063293
Enrollment
Unknown
Registered
2022-09-03
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Hashimoto's thyroiditis

Interventions

Intervention Group:Qinggan Sanjie Xiaoying granule
Control Group:Placebo

Sponsors

Sun Simiao Hospital of Beijing University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. 34 IU/mL < TPOAb < 600 IU/mL; 2. TGAb < 4000 IU/mL; 3. TRAB(-); 4. Thyroid ultrasound showed diffuse enlargement or heterogeneous echo; 5. Aged 18-70 years; 6. Thyroid hormones (FT3, FT4, T3, T4) were within the reference range; 7. Elevated levels of thyroid stimulating hormone (subclinical hypothyroidism); 8. Drug washout period: no clinical trial, immune preparation and Chinese medicine were conducted within 3 months before enrollment; 9. No drugs affecting thyroid hormone metabolism, including corticosteroids, preparations containing vitamins or trace elements, amiodarone a Interferons, lithium preparations, antidepressants or antipsychotics, etc; 10. Did not participate in other clinical studies; 11. Signed the informed consent to participate in this study.

Exclusion criteria

Exclusion criteria: 1. With non-diabetic kidney disease; 2. Severe infection, anemia, or electrolyte imbalance in the previous four weeks; 3. Oliguria, anuria, severe edema, massive pleural or peritoneal effusion; 4. Use of corticosteroids or immunosuppressants in the previous three months; 5. Severe cardiac, cerebral, hepatic, or hemorrhagic diseases, including stroke, transient ischemic attack, significant neurological dysfunction remaining after stroke ,myocardial infarction, unstable angina, ischemic heart disease with coronary artery bypass or PCI surgery, congestive heart failure (cardiac function class III-IV, NYHA rating),hepatic inadequacy with aspartate transaminase(AST) or alanine aminotransferase (ALT)levels more than twice the normal upper limit, severe thrombocytopenia (PLT <10×10^9/L, abnormal coagulation, or active gastrointestinal bleeding; 6. Tuberculosis or mental disorders; 7. Pregnancy or lactation; 8. Participation in other clinical studies.

Design outcomes

Primary

MeasureTime frame
Estimated glomerular filtration rate (eGFR);

Secondary

MeasureTime frame
The incidence rate of eGFR fell by 20%;Adipocyte fatty acid-binding protein(A-FABP);Lipid metabolomics;urinary albumin-to-creatinine ratio (UACR);TCM syndrome integral score;quality of life;

Countries

China

Contacts

Public ContactZhiguo Ding

Sun Simiao Hospital of Beijing University of Traditional Chinese Medicine

dingzhiguo_1@163.com+86 17710573706

Outcome results

None listed

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