This study aims to evaluate the efficacy of two traditional Chinese medicine (TCM) formulas, Danggui Shaoyao San (DSS) and Cuscuta Chinensis (Tu Si Zi), in treating primary dysmenorrhea (PD). Primary dysmenorrhea, a common condition characterized by painful menstrual cramps, affects many women of reproductive age and significantly impacts their quality of life. Conventional treatments, such as NSAIDs and oral contraceptives, often have limited efficacy or side effects, underscoring the need for alternative therapeutic options.
In this randomized, double-blind study, participants will be divided into four groups: DSS, Tu Si Zi, a combination of DSS and Tu Si Zi, and a placebo group. The study will measure treatment outcomes using the Visual Analogue Scale (VAS) for pain and the Menstrual Symptom Questionnaire (MSQ), which captures physical and emotional symptoms. Additionally, TCM-based tools like pulse diagnosis and constitution questionnaires will be employed to explore personalized treatment strategies.
This research seeks to determine whether these TCM formulas can alleviate pain and improve other menstrual symptoms, potentially providing broader benefits than conventional painkillers. The findings aim to support evidence-based integration of TCM in managing dysmenorrhea and inform clinicians and patients about effective therapeutic choices.
Female participants aged 20 to 45 years.
Regular menstrual cycles (21 to 42 days).
History of moderate to severe primary dysmenorrhea (Visual Analogue Scale (VAS) score > 3) persisting for at least three consecutive menstrual cycles.
Able to understand and complete the study questionnaires (e.g., MSQ).
Secondary dysmenorrhea caused by conditions such as endometriosis, pelvic inflammatory disease, or uterine fibroids.
Current use of an intrauterine contraceptive device (IUD).
Irregular menstrual cycles.
Pregnant, breastfeeding, or planning pregnancy within the study period.
Parallel
Danggui Shaoyao San (DSS)
DrugDanggui Shaoyao San is a traditional Chinese medicine (TCM) formula used to regulate blood flow, alleviate pain, and reduce inflammation. Participants in this arm will receive DSS starting 3 to 7 days before menstruation and continue until 3 days after menstruation for two cycles.
Cuscuta Chinensis (Tu Si Zi)
DrugCuscuta Chinensis is a TCM formula traditionally used to nourish kidney essence and improve menstrual health. Participants in this arm will receive Tu Si Zi starting 3 to 7 days before menstruation and continue until 3 days after menstruation for two cycles.
Combination Therapy (DSS + Tu Si Zi)
DrugThis intervention combines Danggui Shaoyao San and Cuscuta Chinensis. Participants will receive both formulas starting 3 to 7 days before menstruation and continue until 3 days after menstruation for two cycles.
Placebo
DrugParticipants in this arm will receive a placebo that matches the appearance of the study medications. The placebo will be administered on the same schedule as the active treatments for two menstrual cycles.
Change in Pain Intensity Measured by the Visual Analogue Scale (VAS)
Pain intensity will be assessed using the Visual Analogue Scale (VAS), where participants rate their pain on a scale of 0 (no pain) to 10 (worst pain imaginable). The change in scores from baseline to post-treatment will be analyzed to evaluate the interventions' effect on reducing primary dysmenorrhea pain.
Change in Menstrual Symptoms Measured by the Menstrual Symptom Questionnaire (MSQ)
The MSQ evaluates physical and emotional menstrual symptoms, such as irritability, fatigue, abdominal pain, nausea, and breast tenderness. Each symptom is rated on a 5-point Likert scale ("Never" to "Always"). Total and individual scores will be analyzed to assess improvements in symptom burden.
Change in the Frequency of Medication Use for Pain Relief
Participants will report the number of times they used pain medication during each menstrual period at baseline and after two menstrual cycles. In addition, the types and doses of pain medications used will be carefully recorded and analyzed to provide a comprehensive evaluation of treatment efficacy. For statistical analysis, the mean frequency of medication use will be calculated for each participant at baseline and after two menstrual cycles.
Correlation Between TCM Pulse Diagnosis Parameters and Menstrual Symptom Severity
Radial artery pulse data will be collected using a TCM pulse diagnosis device, which measures parameters across three positions: cun, guan, and chi on both the left and right wrists. Each position's waveforms will be analyzed within frequency bands of 0-10Hz, 10-50Hz, and 13-50Hz. Additional parameters, such as SER and EP waveforms, represent distinct characteristics of the radial artery pulse. Pulse data will be correlated with symptom severity, as assessed by the Menstrual Symptom Questionnaire (MSQ), to identify patterns or relationships. This analysis aims to explore how pulse energy distributions and waveform variations reflect changes in symptom intensity and treatment outcomes.
Correlation Between TCM Constitution and Treatment Outcomes Using the Body Constitution Questionnaire (BCQ)
The Body Constitution Questionnaire (BCQ) will be used to assess participants' TCM constitution types, including Yang-deficiency, Yin-deficiency, and Stasis. Participants will rate 44 items on a 5-point scale, reflecting the frequency or severity of symptoms over the past month. The study will analyze correlations between changes in BCQ constitution scores and treatment outcomes, including improvements in pain intensity (VAS) and menstrual symptoms (MSQ), to explore the role of TCM constitution in predicting therapeutic efficacy.
Change in Non-Pain Symptoms of Menstruation
Non-pain symptoms of menstruation will be assessed using specific items from the Menstrual Symptom Questionnaire (MSQ), including abdominal bloating, nausea, irritability, anxiety, and fatigue. Each symptom is rated on a 5-point Likert scale ranging from "Never" to "Always." For statistical analysis, the mean scores of individual non-pain symptom items will be calculated for each participant at baseline and after two menstrual cycles.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
