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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
ITMCTR
Registry ID
ITMCTR2200006524
Enrollment
Unknown
Registered
2022-08-22
Start date
2022-08-22
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Hashimoto's thyroiditis

Interventions

Control Group:Placebo
Research Group:Qinggan Sanjie Xiaoying granule

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 70 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) 18 to 70 years old; (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) I signed the informed consent to participate in this study.

Exclusion criteria

Exclusion criteria: (1) Previous or current thyroid diseases, including nodular goiter, hyperthyroidism or subclinical hyperthyroidism, or history of thyroid surgery, radiation iodine therapy, Graves disease; (2) Abnormal liver function (ALT and AST exceed the upper limit of normal value), abnormal renal function (Cr and BUN exceed the upper limit of normal value); (3) Women who are pregnant, lactating or preparing for pregnancy; (4) Serious systemic diseases, such as heart failure (NYHA grade III / IV), severe arrhythmia, unstable angina pectoris, and myocardial infarction within half a year; Acute stroke or severe sequelae, without cognitive ability or unable to take care of themselves and cooperate; (5) Suffering from other immune system diseases; (6) Suffering from malignant tumor; (7) Allergic to the test drug; (8) Surgery or other stress conditions, as well as mental illness, drug or other substance abuse.

Design outcomes

Primary

MeasureTime frame
TPOAb;

Secondary

MeasureTime frame
TGAb;TSH;ultrasound;T4;ThyPRO39;T3;FT4;FT3;

Countries

China

Contacts

Public ContactZhiguo Ding
dingzhiguo_1@163.com17710573706

Outcome results

None listed

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