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Multi-center clinical study of Fuzheng Qingying prescription in the treatment of Hashimoto's thyroiditis

Multi-center clinical study of Fuzheng Qingying prescription in the treatment of Hashimoto's thyroiditis (Normal thyroid functional)

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082031
Enrollment
Unknown
Registered
2024-03-19
Start date
2024-03-20
Completion date
Unknown
Last updated
2024-03-25

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

Conditions

Hashimoto’s thyroiditis

Interventions

Treatment group:Traditional chinese medicine of Fuzheng Qingying
Control group:The placebo of traditional chinese medicine of Fuzheng Qingying

Sponsors

Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Meet the Western medical diagnostic criteria of Hashimoto's thyroiditis; 2. Meet the standard of TCM syndrome differentiation; 3. Patients between the ages of 18 and 70, both male and female; 4. Serum thyroid hormone level is normal; 5. Informed consent, sign the informed consent, and voluntarily take the test.

Exclusion criteria

Exclusion criteria: 1. Patients with serious primary diseases of cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, mental patients, tumors or AIDS patients; ?Abnormal creatinine, blood urea nitrogen > 1.2 times the upper limit of normal, proteinuria > + (> 30mg/dl/100ml); ?ALT > 1.5 times the upper limit of normal value; ? Clinically significant arrhythmia; 2. Pregnant or lactating women with allergic constitution; 3. Those who do not use drugs according to regulations, cannot judge the efficacy, or have incomplete data that affect the efficacy or safety judgment; 4. According to the investigator's judgment, there are other medical histories that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in the work environment, which are likely to cause loss of follow-up; 5. Subjects who are participating in clinical studies of other drugs; 6. People who are allergic to Chinese medicine or to multiple drugs.

Design outcomes

Primary

MeasureTime frame
Total effective rate of TGAb;

Secondary

MeasureTime frame
Total effective rate of TPOAb;Time for TGAb to turn negative ;Time for TGAb to turn negative ;Hypothyroidism rate;

Countries

China

Contacts

Public ContactQue Huafa

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

huafaque@126.com+86 189 1776 3260

Outcome results

None listed

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