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Clinical study of Qilong Sanjie capsule in the treatment of gall disease (phlegm and blood stasis syndrome)

Clinical study of Qilong Sanjie capsule in the treatment of gall disease (phlegm and blood stasis syndrome)

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071502
Enrollment
Unknown
Registered
2023-05-17
Start date
2023-05-17
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

hyperthyroidism(Gall disease)

Interventions

experimental group:Qilong Sanjie capsule
Control group:Thiamazole Tablets

Sponsors

Shandong Provincial Hospital Affiliated to Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Age 18-65 years old (inclusive), male or female; (2) Meet the diagnostic criteria of phlegm and blood stasis syndrome of gall disease in traditional Chinese medicine; (3) Patients who meet the Western medical diagnostic criteria for Graves hyperthyroidism, are currently taking Saizhi, and have normal FT3 and FT4; (4) Patients who sign the informed consent form, voluntarily give informed consent and cooperate with the examination.

Exclusion criteria

Exclusion criteria: (1) Goiter has compression on surrounding organs or retrosternal goiter; (2) Combined with hyperthyroidism crisis; (3) Thyroiditis; (4) Patients with serious heart disease, including myocardial infarction and chronic cardiac insufficiency (NYHA grade III and IV); (5) Liver and kidney function reached one of the following indicators: A. glutamate aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of normal value; b. Alkaline phosphatase or total bilirubin > 2 times the upper limit of normal value; c. Urea nitrogen or blood creatinine > the upper limit of normal value; (6) Allergic constitution or possible allergy to the drug; (7) Pregnant or lactating women or those who plan to become pregnant during the trial or their spouses plan to become pregnant; (8) Those who participated in clinical research of other drugs or medical devices within 1 month before the first administration; (9) Patients with mental diseases, obvious mental disorders or epilepsy; Patients with acute diseases; Patients with current or previous malignant tumor diseases; Those without behavioral ability or cognitive ability; (10) Poor compliance or other conditions that researchers think are not suitable for inclusion (such as the estimated survival time is less than 3 months).

Design outcomes

Primary

MeasureTime frame
TCM syndrome score;

Secondary

MeasureTime frame
thyroid volume;Thyroid autoantibodies (TRAb, TPOAb, TgAb);

Countries

China

Contacts

Public ContactJiajun Zhao

Shandong Provincial Hospital Affiliated to Shandong First Medical University

zxbs1231@126.com+86 151 6888 9899

Outcome results

None listed

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