A Preliminary Study on the Efficacy of Danggui Shaoyao San and Cuscuta Chinensis in Patients with… (NCT06730282) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Preliminary Study on the Efficacy of Danggui Shaoyao San and Cuscuta Chinensis in Patients with Primary Dysmenorrhea
Taiwan200 participantsStarted 2024-12-01
Plain-language summary
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.
Who can participate
Age range20 Years – 45 Years
SexFEMALE
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Inclusion criteria
✓. 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).
✓. Willing to comply with study protocols, including taking study medications and attending follow-up visits.
Exclusion criteria
✕. 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.
✕
What they're measuring
1
Change in Pain Intensity Measured by the Visual Analogue Scale (VAS)
Timeframe: Baseline and after two menstrual cycles (approximately 8 weeks)