Premenstrual SyndromeTTENCT07171814
Cohort Study of Honghua Xiaoyao Tablets in the Treatment of Premenstrual Syndrome Based on Target Trial Emulation Framework
An observational study of Premenstrual Syndrome, run by Lianxin Wang.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Honghua Xiaoyao tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 266 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2025to 30 Sep 2027
- How long will I take part?
- 4 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cohort Study of Honghua Xiaoyao Tablet in the Treatment of Premenstrual Syndrome Based on Target Trial Emulation Framework
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.
Read the 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
- Being tested
- Honghua Xiaoyao tablets
- Keywords
- Honghua Xiaoyao tablet, Target trial emulation, The real world
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Honghua Xiaoyao tabletsDrug
Also called serotonin reuptake inhibitors (SSRIs)
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).
| Study group | Role | What they receive |
|---|---|---|
| Honghua Xiaoyao tablets | The intervention for this cohort includes treatment with Honghua Xiaoyao Tablets. Receives: Drug: Honghua Xiaoyao tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (2)
Change of single index of DRSP scale
In DRSP, the scores of premenstrual somatic symptoms, emotional symptoms, and behavioral symptoms, and the scores of individual indicators and their disappearance rates.
Measured: 4 months
Change of TCM premenstrual syndrome
The TCM premenstrual syndrome score scale was designed according to the theory of TCM, which was used to evaluate the TCM syndromes of patients with premenstrual syndrome, including breast swelling and pain, small abdominal distension, irritability, dizziness, insomnia, headache, difficulty in menstruation and other TCM symptoms and signs such as tongue and pulse. The changes of symptom scores of premenstrual syndrome reflect the improvement or deterioration of the condition. The scale uses a semi-quantitative grading method to score the severity of different symptoms into 0, 2, 4, and 6 points (such as breast pain, etc.) or 0, 1, 2, and 3 points (such as dizziness, etc.). The lowest score was 0, and the highest specific score was determined according to the accumulation of each symptom score. The higher the score, the more severe the condition. The reduction rate of TCM syndrome and the disappearance rate of single symptom in the TCM syndrome score table were calculated.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start30 Sep 2025 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 266 participants (estimated)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Lianxin Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Chaoyangmen Community Health Service Center of Dongcheng District in Beijing, Hepingli Community Health Service Center,Dongcheng District,Beijing
- Responsible party
- Sponsor-investigator, Lianxin Wang, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171814
- Sponsor's protocol ID
- Honghua Xiaoyao Tablets
- Other IDs
- 2022YFC3502004
- Acronym
- TTE
- Status last verified
- Sep 2025
- First submitted
- 6 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Honghua Xiaoyao Tablet in the Treatment of Premenstrual Syndrome Based on Target Trial Emulation Framework
- ClinicalTrials.gov ID
- NCT07171814
- Acronym / sponsor ID
- TTE / Honghua Xiaoyao Tablets
- Conditions
- Premenstrual Syndrome
- Keywords
- Honghua Xiaoyao tablet, Target trial emulation, The real world
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Lianxin WangUniversity, hospital or other
- Collaborators
- Chaoyangmen Community Health Service Center of Dongcheng District in Beijing, Hepingli Community Health Service Center,Dongcheng District,Beijing
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Honghua Xiaoyao tablets | – | Drug: Honghua Xiaoyao tabletsThe intervention for this cohort includes treatment with Honghua Xiaoyao Tablets. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Honghua Xiaoyao tabletsAlso: serotonin reuptake inhibitors (SSRIs)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). | Drug | Honghua Xiaoyao tablets |
Primary outcome
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.
2 secondary outcomes
Change of single index of DRSP scale
Time frame: 4 months
Change of TCM premenstrual syndrome
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Premenstrual Syndrome, run by Lianxin Wang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lianxin Wang, Doctor of Medicine (86-13521781839, wlxing2022@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of premenstrual syndrome (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.