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A randomized, double-blind, placebo-controlled study of Compound Xiaoying Granules in the treatment of Graves' disease with Yin deficiency and phlegm-heat syndrome

A randomized, double-blind, placebo-controlled study of Compound Xiaoying Granules in the treatment of Graves' disease with Yin deficiency and phlegm-heat syndrome

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005094
Enrollment
Unknown
Registered
2021-07-20
Start date
2021-07-26
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Graves Disease

Interventions

Sponsors

Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Conform to the diagnosis of Graves disease; 2. TCM syndrome differentiation is yin deficiency and phlegm-heat syndrome; 3. Age between 18 and 65 years old, gender is not limited; 4. During the lead-in period of the test, FT3 and FT4 were higher than the normal value range, and TSH was lower than the normal value range; 5. The patients voluntarily signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Hyperthyroidism caused by other reasons or not in line with TCM syndrome differentiation of yin deficiency and phlegm heat; 2. Patients with hyperthyroidism crisis and co-infection within the past 1 month; 3. Those who are unwilling to cooperate (referring to those who cannot cooperate with dietary control or do not take medication as prescribed, and who cannot regularly monitor thyroid function as prescribed by a doctor) and mentally ill patients; 4. Pregnant or lactating women, those who plan to become pregnant; 5. Combined with obvious cardiovascular disease (New York Heart Association grade 2 or 3), abnormal liver function (ALTT and AST higher than 1 times the upper limit of normal), abnormal renal function (creatinine greater than 200µmol/L), brain Primary diseases such as vascular disease (acute phase) and hematopoietic system disease (requiring treatment); 6. Allergic constitution or allergic history to multiple drugs (two or more or known ingredients in the drug); 7. Patients with thyroid cancer and other malignant tumors; 8. Patients with active thyroid eye disease; 9. Those who have participated in clinical trials of other drugs within the past 4 weeks; 10. Those who are considered inappropriate by the investigator to participate in clinical trials.

Design outcomes

Primary

MeasureTime frame
thyroid function;TCM syndrome integral;

Secondary

MeasureTime frame
Degree of goiter;

Countries

China

Contacts

Public ContactWang Qiuhong

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

457018418@qq.com+86 13521129702

Outcome results

None listed

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