A Preliminary Study on the Efficacy of Danggui Shaoyao San and Cuscuta Chinensis in Patients with Primary Dysmenorrhea

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-45
SponsorTaichung Tzu Chi Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Danggui Shaoyao San (DSS)
  • Cuscuta Chinensis (Tu Si Zi)
  • Combination Therapy (DSS + Tu Si Zi)
  • Placebo

Treatment groups

200 Participants
are divided into 4 treatment groups

Sponsors and collaborators