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

StatusTerminated
PhaseNot applicable
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Stopped Trial status changed: Unknown → Terminated Sponsor's reason: The study was stopped early before reaching the planned enrollment of 200 participants because the allocated research budget was exhausted and additional study medication could not be funded. Enrollment will not resume. Show 6 more changesShow less
    • Primary completion date changed from estimate of Jun 30, 2026 to Sep 12, 2026
    • Start date changed from estimate of Dec 1, 2024 to Feb 14, 2025
    • Study sites: 1 to 2
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description revised
  2. Minor Changed Registry marked status Unknown; last known: Not Yet Recruiting
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06730282
Lead Sponsor Taichung Tzu Chi Hospital
Conditions
(from sponsor)
Primary Dysmenorrhea (PD), Traditional Chinese Medicine (TCM) Approaches
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov