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Multicenter Randomized Controlled Clinical Observation of Prunella Vulgaris Tablets in the Treatment of Thyroid Nodules

Multicenter Randomized Controlled Clinical Observation of Prunella Vulgaris Tablets in the Treatment of Thyroid Nodules

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096295
Enrollment
Unknown
Registered
2025-01-21
Start date
2023-04-26
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Thyroid nodule

Interventions

Control group:None
Treatment group:Prunella Vulgaris Tablets

Sponsors

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Imaging examination : B-ultrasound examination of thyroid gland found 1 or more nodules,(maximun diameter of nodules<1.0cm ) except for the possibility of compression of surrounding organs and malignant tumors. (2) Symptoms :the nodules can move up and down with swallowing .There is no redness ,swelling ,heat and pain in the nodules.When the nodules are larger ,there may be breathing difficulties ,neck pulling sensation and other sympotoms. (3) Physical signs : thyroid examination showed palpable mass and unilateral or bilateral goiter ,on which 1 more nodules could be palpable ,with clear boundaries ,no tenderness, movement up and down with swallowing, no tremor ,no vascular murmur. (4) Thyroid function and autoantibodies were all within the normal reference range. (5) The patient voluntarily did not undergo puncture biopsy. (6) Aged between 18 and 75 years. (7) Gender unlimited. (8) All subjects had signed written informed consent ,had not received treatment for thyriod nodule disease and not participated in other clinical studies.

Exclusion criteria

Exclusion criteria: (1) Exclude patients with other thyroid diseases or abnormal thyroid function. (2) Exclude patients with ultrasound diagnosis 4a,4b or confirmed thyroid tumor. (3) Pregnant or lactating women. (4) Patients who take drugs within 3 months have influence on thyroid function. (5) Patients with severe systemic infection or serious diseases of the heart ,brain, liver, kidney, cardiovascular system cancer and mental illness. (6) Patients are allergic to therapeutic drugs,complicated with epilepsy and other abnormal consciousness ,unable to cooperate with treatment. (7) Patients who have received clinical treatment for the disease or are undergoing other clinical trials.

Design outcomes

Primary

MeasureTime frame
Size comparison of thyroid nodules before and after;

Secondary

MeasureTime frame
FT3;TSH;FT4;TGAb;TPOAb;

Countries

China

Contacts

Public ContactChen Qiu

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Chenqiu1969@163.com+86 189 8188 5702

Outcome results

None listed

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