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A randomized controlled trial of the efficacy and safety of cardiac granules in the treatment of patients with benign thyroid nodules with angina symptoms

A randomized controlled trial of the efficacy and safety of cardiac granules in the treatment of patients with benign thyroid nodules with angina symptoms

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063915
Enrollment
Unknown
Registered
2022-09-20
Start date
2022-09-20
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

benign thyroid nodules with symptoms of angina

Interventions

Experimental group:Basic treatment + Xintong granules

Sponsors

Zibo Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. No gender limit, aged between 18 and 80 years; 2. The patient was diagnosed with benign thyroid nodules according to the diagnostic criteria of Chinese medicine and Western medicine; 3. During angina attack, ST-T segment of electrocardiogram changes, ST-segment depression (level or downward oblique depression, >=0.1mV), T-wave is low or inverted, accompanied by different degrees of chest tightness, chest pain and other typical symptoms of angina; 4. Thyroid ultrasound TI-RADS were graded 2-3, with single or multiple nodules <=4cm; 5. No drugs tested in this study were used within 3 months before enrollment; 6. Join the study voluntarily and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Uncontrolled or improper treatment of blood pressure and blood sugar. Severe cardiopulmonary insufficiency or severe arrhythmia (rapid atrial fibrillation and flutter, paroxysmal secondary ventricular tachycardia, greater than secondary atrioventricular block, etc.); 2. A history of acute myocardial infarction within the past 2 months or coronary revascularization (e.g. PCI) within the past 12 months; 3. Patients who plan to undergo iodine therapy/screening or other interventions for thyroid nodules during the study period; 4. Those who received iodine treatment/screening within 6 months; Receive thyroxine therapy within 3 months; 5. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal, serum creatinine > 2 times the upper limit of normal, or receiving renal dialysis; 6. Patients with a history of cervical irradiation or cystic thyroid nodules; 7. Chronic complete occlusion of Coronary artery (CTO); 8. Patients who are allergic to drugs used in this study; 9. Mental and neurological disorders, unable to express their wishes correctly; 10. Pregnant patients, lactating patients and patients of childbearing age who do not take contraceptive measures; 11. Patients with digestive, urinary, respiratory, blood, nervous, endocrine system and other serious primary diseases that cannot be effectively controlled clinically; 12. Patients who have participated in or are currently participating in clinical trials of other drugs or medical devices within the previous 3 months; 13. Those deemed unsuitable for inclusion by the researchers.

Design outcomes

Primary

MeasureTime frame
Therapeutic effect of 20% reduction in thyroid nodule volume before and after treatment;

Secondary

MeasureTime frame
Quantitative score of TCM symptoms before and after treatment;Thyroid function in two groups before and after treatment (TSH, FT3, FT4);Changes in ultrasound elastography scores for thyroid nodules before and after treatment;Incidence of adverse reactions;

Countries

China

Contacts

Public ContactLi Yiming
13969390782@163.com+86 18678186629

Outcome results

None listed

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