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Evaluation of Clinical Efficacy of Xiaoying Decoction Combined with Vitamin D in the Intervention of Hashimoto's Thyroiditis

Evaluation of Clinical Efficacy of Xiaoying Decoction Combined with Vitamin D in the Intervention of Hashimoto's Thyroiditis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000332
Enrollment
Unknown
Registered
2024-08-29
Start date
2024-10-01
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Hashimoto's thyroiditis

Interventions

The combination Group:Patients will receive Xiaoyao Decoction orally 30 ml twice daily half an hour after breakfast and dinner along with calcitriol capsules (0.25 µg) half an hour after breakfast.
Control Group:Patients will be observed with follow-up only and will not receive any medication.
Vitamin D Group:Patients will receive calcitriol capsules (0.25 µg) half an hour after breakfast
Xiaoyao Decoction Group: Patients will receive Xiaoyao Decoction orally 30 ml twice daily half an hour after breakfast and dinner.

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Patients who meet the diagnostic criteria of Western medicine for Hashimoto's thyroiditis and are diagnosed with Qi-Yin Deficiency and Qi-Stagnation with Phlegm Obstruction according to Traditional Chinese Medicine (TCM). 2.Patients who have not used thyroid hormone medications in the past month prior to enrollment. 3.Patients with normal levels of free triiodothyronine (FT3) free thyroxine (FT4) and thyroid-stimulating hormone (TSH). 4.Adults aged 18 to 75 years regardless of sex. 5.Patients who have signed an informed consent form and are willing to participate voluntarily.

Exclusion criteria

Exclusion criteria: 1. Individuals with abnormal levels of free triiodothyronine (FT3) free thyroxine (FT4) or thyroid-stimulating hormone (TSH). 2. Individuals with sufficient levels of vitamin D defined as 25-hydroxyvitamin D [25(OH)D] > 50 nmol/L. 3. Individuals who have recently taken vitamin D or cod liver oil supplements. 4. Individuals who have used immunomodulators or immunosuppressants within the past three months or those with other thyroid disorders or autoimmune diseases. 5. Individuals with a history of cancer or other severe illnesses that would limit their life expectancy. 6.Individuals with significant liver or kidney dysfunction or other severe underlying conditions affecting the heart lungs or brain. 7.Pregnant or breastfeeding women. 8.Individuals with a history of substance abuse (including alcohol and drugs) or severe mental health disorders. 9.Individuals with known allergies to the study medication. 10.Individuals who do not meet other requirements of this study protocol..

Design outcomes

Primary

MeasureTime frame
Thyroid antibodies;

Secondary

MeasureTime frame
TCM symptom score;FT4;Thyroid ultrasound;TSH;25(OH)D;FT3;

Countries

China

Contacts

Public ContactChi Chen

Department of Endocrinology Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

chenchi0216@126.com13611962072

Outcome results

None listed

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