Not Yet RecruitingNot Applicable

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

266 participantsStarted 2025-09-30

Plain-language 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.

Who can participate

Age range18 Years – 40 Years

SexFEMALE

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

The change of premenstrual syndrome

Timeframe: 4 months

Trial details

NCT IDNCT07171814

SponsorLianxin Wang

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-07-30

Contact for this trial

Lianxin Wang, Doctor of Medicine

86-13521781839 wlxing2022@163.com

View on ClinicalTrials.gov More Premenstrual Syndrome trials