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

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.

Conditions

• Primary Dysmenorrhea (PD)
• Traditional Chinese Medicine (TCM) Approaches

Interventions

DRUG

Danggui Shaoyao San (DSS)

Danggui 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.

DRUG

Cuscuta Chinensis (Tu Si Zi)

Cuscuta 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.

DRUG

Combination Therapy (DSS + Tu Si Zi)

This 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.

DRUG

Placebo

Participants 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.

Sponsors & Collaborators

• Taichung Tzu Chi Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-01

Primary Completion

2026-06-30

Completion

2026-06-30

Countries

• Taiwan

Study Locations