Evaluation of clinical efficacy and safety of herbs of rich-Iodine for Graves' Hyperthyroidism (the HIGHT trial) patients with oral ATDs intolerant

Phase 1

• Conditions: Graves' disease

• Registration Number: ITMCTR2000003282
• Lead Sponsor: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Diagnosis criteria (Guidelines for Clinical Diagnosis and Treatment of thyroid disease in 2007, CSE)
1. Clinical manifestations of hyperthyroidism;
2. The presence of diffuse goiter;
3. The suppressed serum TSH and elevated thyroid hormones (FT4 and FT3);
4. The presence of exophthalmos;
5. The presence of Pretibial myxedema(PM);
6. The presence of TSH-Receptor Antibodies (TRAb/TSAB).
TCM symptoms criteria (Chinese New Medicine Treatment of Diabetes Clinical Research Guiding Principle) yin deficiency with heat.
Inclusion criteria
1. Adults over 18 years to under 70 years of age;
2. Fulfill GD diagnostic criteria;
3. Intolerance to high-dose therapy with Methimazole (MMI) or Propylthiouracile (PTU), and refuse thyroidectomy or radiotherapy (I131) RAI;
4. Fulfill TCM diagnostic criteria;
5. Those who have voluntarily signed a written consent form approved by the IRB after sufficient explanation of this study.

Exclusion Criteria

1. Hyperthyroidism crisis;
2. Symptomatic compression or large goiter;
3. Subjects who allergy to the components in TCM and/or placebo;
4. Those who have thiocarbamides-associated major side effects including of severe hepatitis(elevation of AST or ALT more than double the normal upper limit), agranulocytosis (neutrophil count < 500/mL), severe exfoliative dermatitis;
5. Women who are pregnant or lactating, or preparing for pregnancy and lactating women;
6. Subjects with a history of alcohol abuse, drug abuse, or mental diseases;
7. Those who are in seriously unstable medical condition, such as cardiovascular disease, cerebrovascular disease, hepatobiliary disease, renal disease or problems in the urinary reproductive system, or neoplasms, or whose treatment with any medication potentially influencing thyroid function (IFN-gama, amiodarone, lithium, corticosteroids, etc.);
8. Subjects who have taken other clinical trial drugs within 3 months;
9. Subjects who are thought to be inappropriate for this study.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
thyroid function;

Secondary Outcome Measures

Name	Time	Method
General physical examination;Thyroid Imaging (US.);Pregnancy Test;Evaluation of TCM Syndrome;Quality of life (QoL);TRAb, TgAb, TPOAb;Record of medical history;Demographic information;