Cohort Study of Honghua Xiaoyao Tablet in the Treatment of Premenstrual Syndrome Based on Target Trial Emulation Framework
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 266
- Primary Endpoint
- The change of premenstrual syndrome
Study Overview
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 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Honghua Xiaoyao tablets
The intervention for this cohort includes treatment with Honghua Xiaoyao Tablets.
Intervention: Honghua Xiaoyao tablets (Drug)
Outcomes
Primary Outcomes
The change of premenstrual syndrome
Time Frame: 4 months
The Daily Record of Symptom Severity (DRSP) is a tool for assessing symptoms of premenstrual syndrome. The scale contained 14 items, including depression, anxiety and tension, emotional instability, irritability, reduced interest, inattention, lethargy and fatigue, abnormal appetite, abnormal sleep, feeling out of control, body pain and swelling. Each item was scored from 1 to 6 points according to the severity of symptoms (1 = none, 2 = very mild, 3 = mild, 4 = moderate, 5 = severe, 6 = extremely severe). The total score of premenstrual symptoms, physical/emotional/behavioral symptoms and individual index scores were calculated. In this study, participants were asked to fill in the form of the most severe feeling on the 5th day before the menstrual cycle and the previous menstrual cycle before the initiation of the medication at 20:00 to 22:00 every day on the 5th to 9th day of the menstrual cycle to evaluate the changes in symptoms before and after the treatment.
Secondary Outcomes
- Change of single index of DRSP scale(4 months)
- Change of TCM premenstrual syndrome(4 months)
Investigators
Lianxin Wang
Principal Investigator
China Academy of Chinese Medical Sciences