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"The Clinical Efficacy Observation of 'Jie Jie Fang' for the Treatment of Phlegm Qi Stagnation Type Thyroid Nodules"

"The Clinical Efficacy Observation of 'Jie Jie Fang' for the Treatment of Phlegm Qi Stagnation Type Thyroid Nodules"

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001524
Enrollment
Unknown
Registered
2026-06-20
Start date
2026-06-30
Completion date
Unknown
Last updated
2026-08-03

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:Basic treatment: Refer to the 2025 'Expert Consensus on Thyroid Nodule Risk Assessment and Health Management for Physical Examination Populations' for patient education about thyroid nod
Treatment group:Basic treatment + Nodule Formula: Basic treatment: Same as control group. Nodule Formula: Astragalus 30g, Processed Polygonum Multiflorum 12g, Zedoary 9g, Prunella Vulgaris 15g, Bergam

Sponsors

Shanghai University of Traditional Chinese Medicine Affiliated Yueyang Integrated Chinese and Western Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Age =18 years and =70 years, gender unrestricted; (2) First diagnosed during the initial visit, meeting the diagnostic criteria for thyroid nodules as per the "Guidelines for the Diagnosis and Treatment of Thyroid Nodules and Differentiated Thyroid Cancer" (TI-RADS classification =4a level); (3) Chinese medical syndrome differentiation belongs to phlegm Qi stagnation syndrome; (4) Maximum diameter of the nodule =10mm and =30mm; (5) Thyroid function and antibodies are within normal ranges; (6) Understanding, agreement to participate in this study, and signing of the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with nodules that have a possibility of malignancy as indicated by examination; (2) Patients who have taken other medications for thyroid nodules or undergone thyroid surgery or iodine-131 therapy within the past year; (3) Patients with other severe underlying diseases (such as impaired heart, liver, or kidney function, malignant tumors, etc.); (4) Pregnant or breastfeeding women, or women planning to conceive within the next year; (5) Patients with long-term alcohol abuse, drug dependence, or mental illness; (6) Patients with a known allergy to the investigational drug or any of its components; (7) Patients who have participated in or are currently participating in other clinical studies within the past month; (8) Patients deemed unsuitable for participation in this clinical study by the investigator.

Design outcomes

Primary

MeasureTime frame
Thyroid Nodule Volume;

Secondary

MeasureTime frame
Maximum Diameter of Largest Thyroid Nodule;TCM Syndrome Score;Quality of Life Rating;

Countries

China

Contacts

Public ContactYang Hongjie

Shanghai University of Traditional Chinese Medicine Affiliated Yueyang Integrated Chinese and Western Medicine Hospital

yanghongjie1964@aliyun.com13901618095

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026