NCT07171814

Cohort Study of Honghua Xiaoyao Tablets in the Treatment of Premenstrual Syndrome Based on Target Trial Emulation Framework

Cohort Study of Honghua Xiaoyao Tablet in the Treatment of Premenstrual Syndrome Based on Target Trial Emulation Framework

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 266 (estimated)
• Sponsor: Lianxin Wang · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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 oral: 4 tablets each time, 3 times a day, for a continuous medication period of 3 months. Doctors were required to provide detailed guidance on medication use and record prescriptions; during follow-up visits, the remaining drugs should be checked to track patients' medication adherence. The patients in the non-exposed group did not use Honghua Xiaoyao Tablets or other targeted drugs, and only received routine clinical observation. No drug intervention was applied to them after obtaining informed consent. However, they completed the follow-up plan as well as various efficacy and safety assessments simultaneously with the exposed group. If patients needed to withdraw from the study due to their condition during the study period (in accordance with the Management of Premenstrual Disorders: ACOG Clinical Practice Guideline No. 7, this applied when premenstrual dysphoric disorder (PMDD) or premenstrual syndrome (PMS) symptoms occurred during follow-up and the patient could not tolerate them), on the premise that the patient had given full informed consent, doctors could recommend first-line drugs such as selective serotonin reuptake inhibitors (SSRIs) for intervention and other treatment regimens in accordance with clinical standards. At the same time, the reasons for the patient's withdrawal and subsequent treatment status should be recorded in detail. Time zero was defined as the start of the treatment period, i.e., when the doctor issued the prescription. Follow-up visits began at this point, with one follow-up visit conducted every month. The follow-up period covered the 3-month medication period and 1 month after drug discontinuation. This clinical observational study was scheduled to be completed within 2 years.

Conditions

• Premenstrual Syndrome

Interventions

Type	Name	Description
DRUG	Honghua Xiaoyao tablets	The non-exposed group (patients who did not receive Honghua Xiaoyao Tablets or other targeted drug treatments) only received routine clinical observation, and no drug intervention was applied after obtaining informed consent. If patients need to withdraw from the study due to their condition during the study period, on the premise that the patients have given full informed consent, doctors shall recommend other treatment regimens in accordance with clinical standards (when necessary, first-line drugs such as selective serotonin reuptake inhibitors (SSRIs) may be selected for intervention).

Timeline

• Start date: 2025-09-30
• Primary completion: 2027-07-30
• Completion: 2027-09-30
• First posted: 2025-09-15
• Last updated: 2025-09-15