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The Cohort Study on Ningying Formula in the Treatment of Graves' Disease

Observation on Ningying Formula in the Treatment of Graves' Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2026000298
Enrollment
Unknown
Registered
2026-02-09
Start date
2025-01-01
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Graves disease

Interventions

Combination Therapy Group:The combination of and therapy
Western medicine control group:Basic treatment of Western medicine

Sponsors

Shanghai University of Traditional Chinese Medicine Affiliated Municipal Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age 18–70 years; Meets the diagnostic criteria for Graves' disease, based on the "Chinese Guidelines for the Diagnosis and Treatment of Hyperthyroidism and Other Causes of Thyrotoxicosis" and the "2016 American Thyroid Association Guidelines for the Diagnosis and Management of Hyperthyroidism and Other Causes of Thyrotoxicosis," with at least 2 of the following: typical hyperthyroidism manifestations (palpitations, sweating, weight loss, tremors, diffuse goiter, exophthalmos, etc.); laboratory indicators: TSH < 0.1 mIU/L, elevated FT4 and/or FT3, positive TRAb; imaging: thyroid ultrasound showing diffuse enlargement with rich blood flow. Prospective cohort patients provide informed consent; Meets the above criteria and does not have any of the exclusion criteria.

Exclusion criteria

Exclusion criteria: Pregnant or breastfeeding women; Severe heart/liver/kidney dysfunction (ALT > 3xULN, eGFR < 60 ml/min/1.73m2); Abnormal blood routine: white blood cells <3x10^9/L, neutrophils <1.5x10^9/L, or accompanied by other malignant hematological diseases; Coexisting other systemic autoimmune diseases or malignant tumors; Previous history of subtotal thyroidectomy or radioactive iodine-131 therapy; Allergy to MMI or herbal components used in the study; Failure to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Dynamic changes in TRAb levels (IU/L) and the proportion turning negative;18-month discontinuation rate;

Secondary

MeasureTime frame
Dynamic Changes in Levels of FT3, FT4, TSH, and TSI;Biochemical recovery time: the first time TSH, FT4, and FT3 return to normal levels.;Recurrence Rate and Recurrence Time;

Countries

China

Contacts

Public ContactChen Yi

Shanghai City Hospital of Traditional Chinese Medicine

chenyi197831@163.com18116070305

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Mar 14, 2026