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Efficacy and Safety of the Tiaomian Recipe in the Treatment of Autoimmune Thyroiditis : A Multicenter, Randomized, Double-blind, Placebo-controlled Study

Efficacy and Safety of the Tiaomian Recipe in the Treatment of Autoimmune Thyroiditis : A Multicenter, Randomized, Double-blind, Placebo-controlled Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070102
Enrollment
Unknown
Registered
2023-04-02
Start date
2023-04-01
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Autoimmune Thyroiditis

Interventions

Treatment Group:Tiaomian Recipe
Control Group:placebo

Sponsors

The Affiliated Hospital to Changchun University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.TPOAb > 300 IU/ml and within the measurable range; 2.FT4 is normal, TSH is normal or elevated, but<10 mIU/L, including subjects taking L-T4; 3.It meets the diagnostic criteria of stagnation of liver-qi and deficiency of spleen and kidney in traditional Chinese medicine; 4.Age from 18 - 70 years old ; 5.Sign informed consent.

Exclusion criteria

Exclusion criteria: 1.Exposure to an iodine-containing radiocontrast dye during the previous 3 months; 2.Currently receiving systemic (oral or injection) glucocorticoid treatment, receiving immunosuppressive agents and immunomodulators, biological agents, and some drugs that may affect the peripheral conversion of T4 to T3 or affect thyroid autoimmunity, such as selenium supplements, vitamin D, amiodarone, propranolol, penicillamine, lithium, and prunella vulgaris preparations; 3.Combined with other autoimmune diseases or malignant tumors; 4.The unstable or acute stage of heart, brain, liver, spleen, kidney, respiratory, blood and other system diseases and complications; 5.Liver function (ALT or AST)>2 times the upper limit of normal value, and/or creatinine (Cr)>the upper limit of normal value; 6.Smoking patients within 6 months; 7.Preparing pregnant, pregnant and lactating women; 8.Patients with mental diseases or dementia; 9.Participate in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Changes in thyroid peroxidase antibody from baseline to week 24;

Secondary

MeasureTime frame
Thyroid peroxidase antibody at week 12;thyroglobulin antibody;thyroid stimulating hormone;free thyroxine;Quality of Life Questionnaire for Patients with Thyroid Disease;Quantitative scoring of TCM syndromes;

Countries

China

Contacts

Public ContactXiaolin Tong

The Affiliated Hospital to Changchun University of Chinese Medicine

tongxiaolin@vip.163.com13910183346

Outcome results

None listed

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