Status:
NOT_YET_RECRUITING
Cohort Study of Honghua Xiaoyao Tablets in the Treatment of Premenstrual Syndrome Based on Target Trial Emulation Framework
Lead Sponsor:
Lianxin Wang
Collaborating Sponsors:
Chaoyangmen Community Health Service Center of Dongcheng District in Beijing
Hepingli Community Health Service Center,Dongcheng District,Beijing
Conditions:
Premenstrual Syndrome
Eligibility:
FEMALE
18-40 years
Brief Summary
To evaluate the efficacy and safety of Honghua Xiaoyao tablets in the treatment of premenstrual syndrome, and the results were further analyzed and evaluated by target trial simulation (TTE) framework...
Detailed Description
In this study, the patients in the exposed group were treated with Honghua Xiaoyao Tablets, which were provided by Jiangxi Puzheng Pharmaceutical Co., Ltd. The administration method of this drug was o...
Eligibility Criteria
Inclusion
- Age:18-40 years old (both ends included);
- According to the 8th edition of "Obstetrics and Gynecology" (2014), patients diagnosed with premenstrual syndrome;
- In accordance with the TCM syndrome differentiation standard of liver depression and qi stagnation.
Exclusion
- those who were allergic to the ingredients and excipients of Honghua Xiaoyao tablet (exposure group);
- In the non-exposed group, those receiving or planning to receive other targeted medications for PMS, such as serotonin reuptake inhibitors (SSRIs), hormones, etc.;
- irregular menstrual cycle (menstrual cycle not within 28±7 days);
- serious diseases of cardiovascular, cerebrovascular, hematopoietic system, liver and kidney, and malignant tumors;
- pregnant or lactating women, or those who plan to become pregnant within 6 months;
- patients with mental illness and alcohol or drug dependence; Patients with other complicated lesions were not eligible for this study.
Key Trial Info
Start Date :
September 30 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
266 Patients enrolled
Trial Details
Trial ID
NCT07171814
Start Date
September 30 2025
End Date
September 30 2027
Last Update
September 15 2025
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