Skip to content

A randomized, double-blind, placebo-controlled clinical study of FuzhengQingying prescription in the treatment of Hashimoto's thyroiditis

A randomized, double-blind, placebo-controlled clinical study of FuzhengQingying prescription in the treatment of Hashimoto's thyroiditis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068092
Enrollment
Unknown
Registered
2023-02-07
Start date
2023-02-07
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Hashimoto's thyroiditis

Interventions

Experimental group:Western medicine standard treatment + Fuzhengqingying granules
Placebo group:Western medicine standard treatment + Fuzhengqinggall granule simulation agent

Sponsors

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. In line with Western diagnostic standards for Uhashimoto's thyroiditis; 2. Conforming to TCM syndrome differentiation standards; 3. Patients between the ages of 18 and 70, both male and female; 4. Serum thyroid hormone level is normal or low; 5. Informed consent, sign informed consent, and voluntarily take the test.

Exclusion criteria

Exclusion criteria: 1. Those who do not meet the diagnostic criteria and inclusion criteria; 2. Patients with serious primary diseases of cardiovascular, cerebrovascular, liver, kidney and hematopoietic systems, mental patients, tumors or AIDS patients; (1) Abnormal creatinine, blood urea nitrogen > 1.2 times the upper limit of normal value, albuminuria > + (> 30mg/dl/100ml); (2) ALT > 1.5 times the upper limit of normal value; (3) Arrhythmia of clinical significance; 3. Pregnant or lactating women, allergic constitution or abnormal liver function; 4. Combined with hyperthyroidism and high serum thyroid hormone level; 5. Those who do not meet the inclusion criteria, do not use drugs as prescribed, cannot judge the efficacy, or have incomplete data that affect the efficacy or safety evaluation; 6. Subjects who are participating in clinical studies of other drugs; 7. Patients who have used other Chinese medicine or Chinese herbal treatment; 8. People who are allergic to traditional Chinese medicine or to multiple drugs.

Design outcomes

Primary

MeasureTime frame
Antibody reduction response rate;

Secondary

MeasureTime frame
Remission time and remission rate of clinical symptoms;Recovery rate of clinical symptoms;Safety evaluation index: incidence of adverse events/reactions;There were 5 types of lymphocytes;aldosterone;Angiotensin I;PCC;adrenocorticotropic hormone;AII;Homocysteine;NO;Superoxide dismutase;TCM syndrome score;

Countries

China

Contacts

Public ContactQue Huafa

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

huafaque@126.com+86 13551610241

Outcome results

None listed

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