Can a traditional chinese herb ease PMS symptoms?
NCT ID NCT07171814
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study will look at whether Honghua Xiaoyao tablets, a traditional Chinese medicine, can help relieve symptoms of premenstrual syndrome (PMS) in 266 women aged 18 to 40. The researchers will track symptom changes using a daily diary and compare women who take the tablets to those who don't. The goal is to see if the treatment reduces common PMS issues like mood swings, fatigue, and pain.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Honghua Xiaoyao tablet (a traditional Chinese medicine)
- What this could lead to
- If successful, this could provide a treatment option for women with premenstrual syndrome, potentially easing symptoms like mood swings, fatigue, and pain.
- What could go wrong
- This is an observational study, not a randomized controlled trial, so results may be less reliable. The study hasn't started yet, and the treatment is a traditional medicine with limited prior evidence.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 266 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 to 40 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age:18-40 years old (both ends included); 2. According to the 8th edition of "Obstetrics and Gynecology" (2014), patients diagnosed with premenstrual syndrome; 3. In accordance with the TCM syndrome differentiation standard of liver depression and qi stagnation. Exclusion Criteria: 1. those who were allergic to the ingredients and excipients of Honghua Xiaoyao tablet (exposure group); 2. In the non-exposed group, those receiving or planning to receive other targeted medications for PMS, such as serotonin reuptake inhibitors (SSRIs), hormones, etc.; 3. irregular menstrual cycle (menstrual cycle not within 28±7 days); 4. serious diseases of cardiovascular, cerebrovascular, hematopoietic system, liver and kidney, and malignant tumors; 5. pregnant or lactating women, or those who plan to become pregnant within 6 months; 6. patients with mental illness and alcohol or drug dependence; Patients with other complicated lesions were not eligible for this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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