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High risk assessment of thyroid nodules and traditional Chinese medicine intervention combined with disease and syndrome

Scientific and technological innovation project of China Academy of Chinese Medicine Sciences

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000005
Enrollment
Unknown
Registered
2024-01-15
Start date
2022-09-30
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Thyroid nodules

Interventions

control group:Prunella flake
Test group:Shugan Jianpi formula

Sponsors

Guang'anmen Hospital of China Academy of Chinese Medicine Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: standard constrain: (1) Age 18-75 years old; (2) In line with the ultrasound diagnosis of thyroid nodules, including solid, cystic-solid, cystic nodules, and inflammatory nodules, and the long diameter of thyroid nodules = 0.5 cm and < 5.0 cm; (3)Less than 4 bilobular thyroid nodules; (4) Fine needle aspiration biopsy (FNAB) cytopathology of high-risk nodules suggests non-malignant lesions; (5) Meet the diagnostic criteria of TCM syndrome of gall disease with liver stagnation and spleen deficiency syndrome; (6) Those who signed the informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria: (1) Those who have childbearing needs during pregnancy, lactation and within the past 12 months; (2) Nodule with clustered or coarse calcification on the edge or inside of the nodule; (3) Those who are allergic to traditional Chinese medicine or its components; (4)Patients with serious primary diseases or mental illness such as liver, kidney and hematopoietic system; (5) Patients who have been diagnosed with thyroid cancer or combined with other malignant tumors; (6) Patients with obvious local compression symptoms of the thyroid gland, hoarseness, dysphagia, etc. who meet the indications for surgical treatment and need surgical treatment; (7) Anyone who is judged by the investigator to be unsuitable to participate in this trial; (8) Those who have other concomitant medication related to thyroid function and nodule treatment.

Design outcomes

Primary

MeasureTime frame
Sum of products of vertical diameters of nodules;—

Secondary

MeasureTime frame
Thyroid function;TCM syndrome score;Thyroid enlargement and lymph nodes;Pittsburgh Sleep Quality Score;—

Countries

China

Contacts

Public ContactZhang Yuren

Guang'anmen Hospital of China Academy of Chinese Medicine Sciences

liz_099@163.com13811177596

Outcome results

None listed

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