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

NCT07171814 | Not Yet Recruiting DMC

• 2 other identifiers: Honghua Xiaoyao Tablets2022YFC3502004
• Study Type: observational
• Target: 266
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Premenstrual Syndrome

Keywords

Honghua Xiaoyao tablet; Target trial emulation; The real world

Outcome Measures

Primary Outcomes (1)

• The change of premenstrual syndrome

  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.

  4 months

Secondary Outcomes (2)

• Change of single index of DRSP scale

  4 months

• Change of TCM premenstrual syndrome

  4 months

Study Arms (1)

Honghua Xiaoyao tablets

The intervention for this cohort includes treatment with Honghua Xiaoyao Tablets.

Drug: Honghua Xiaoyao tablets

Interventions

Honghua Xiaoyao tablets DRUG

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).

Also known as: serotonin reuptake inhibitors (SSRIs)

Honghua Xiaoyao tablets

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The somatic symptoms included headache, abdominal distension, limb swelling, breast pain, and insufficient motor coordination. Mental symptoms included irritability, emotional instability, depression and anxiety, changes in sexual desire, physical fatigue, insomnia, and loss of appetite. Behavioral changes are characterized by inattention, accidents, criminality, and suicidal tendencies, and these symptoms disappear after menstruation. The diagnostic basis is that if the above physical, mental and behavioral changes occur repeatedly and periodically during the luteal phase and last for more than three menstrual cycles, premenstrual syndrome can be diagnosed.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lianxin Wang: lead
• Chaoyangmen Community Health Service Center of Dongcheng District in Beijing: collaborator
• Hepingli Community Health Service Center,Dongcheng District,Beijing: collaborator

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Selective Serotonin Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs

Central Study Contacts

Lianxin Wang, Doctor of Medicine

CONTACT

86-13521781839; wlxing2022@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2025
• First Posted: September 15, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share