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

NCT06730282 | Not Yet Recruiting DMC

• 1 other identifier: REC113-20
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Primary Dysmenorrhea; Traditional Chinese Medicine (TCM); Danggui Shaoyao San (DSS); Cuscuta Chinensis (Tu Si Zi); Herbal Medicine

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and after two menstrual cycles (approximately 8 weeks)

Secondary Outcomes (4)

• Change in Menstrual Symptoms Measured by the Menstrual Symptom Questionnaire (MSQ)

  Baseline and after two menstrual cycles (approximately 8 weeks)

• Change in the Frequency of Medication Use for Pain Relief

  Baseline and after two menstrual cycles (approximately 8 weeks)

• Correlation Between TCM Pulse Diagnosis Parameters and Menstrual Symptom Severity

  Baseline and after two menstrual cycles (approximately 8 weeks)

• Correlation Between TCM Constitution and Treatment Outcomes Using the Body Constitution Questionnaire (BCQ)

  Baseline and after two menstrual cycles (approximately 8 weeks)

Other Outcomes (1)

• Change in Non-Pain Symptoms of Menstruation

  Baseline and after two menstrual cycles (approximately 8 weeks)

Study Arms (4)

Danggui Shaoyao San

EXPERIMENTAL

Participants in this group will receive Danggui Shaoyao San, a traditional Chinese medicine (TCM) formula, for the treatment of primary dysmenorrhea. The medication will be administered starting 3 to 7 days before menstruation and continued until 3 days after menstruation for two consecutive menstrual cycles. Danggui Shaoyao San is intended to regulate blood flow, reduce inflammation, and alleviate uterine contractions associated with dysmenorrhea.

Drug: Danggui Shaoyao San (DSS)

Cuscuta Chinensis

EXPERIMENTAL

Participants in this group will receive Cuscuta Chinensis, a TCM formula commonly used to support kidney function and alleviate menstrual pain. The medication will be administered starting 3 to 7 days before menstruation and continued until 3 days after menstruation for two consecutive menstrual cycles. This group aims to evaluate the efficacy of Cuscuta Chinensis in managing dysmenorrhea symptoms.

Drug: Cuscuta Chinensis (Tu Si Zi)

Danggui Shaoyao San + Cuscuta Chinensis

EXPERIMENTAL

articipants in this group will receive a combination of Danggui Shaoyao San and Cuscuta Chinensis. The combined therapy will be administered starting 3 to 7 days before menstruation and continued until 3 days after menstruation for two consecutive menstrual cycles. This group aims to assess whether the combination therapy provides enhanced efficacy in reducing pain and other menstrual symptoms compared to single interventions.

Drug: Combination Therapy (DSS + Tu Si Zi)

Placebo

PLACEBO COMPARATOR

Participants in this group will receive a placebo that matches the study medications in appearance and packaging. The placebo will be administered starting 3 to 7 days before menstruation and continued until 3 days after menstruation for two consecutive menstrual cycles. This group serves as a control to evaluate the specific effects of the active interventions on primary dysmenorrhea.

Drug: Placebo

Interventions

Danggui Shaoyao San (DSS) DRUG

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.

Danggui Shaoyao San

Cuscuta Chinensis (Tu Si Zi) DRUG

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.

Cuscuta Chinensis

Combination Therapy (DSS + Tu Si Zi) DRUG

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.

Danggui Shaoyao San + Cuscuta Chinensis

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: This study is open to individuals who self-identify as female and experience menstrual cycles. Eligibility is determined based on biological sex at birth, as the condition being studied, primary dysmenorrhea, specifically affects individuals with a uterus.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Use of anticoagulant medications (e.g., aspirin, warfarin, or heparin).
• Known allergies to any components of the study medications.
• Severe uncontrolled systemic diseases (e.g., neurological disorders, immunodeficiency, or bleeding disorders).
• Concurrent use of other herbal medicines or alternative treatments for premenstrual syndrome or dysmenorrhea.
• Participation in another clinical trial during the study period.

Sponsors & Collaborators

• Taichung Tzu Chi Hospital: lead

Study Sites (1)

Taichung Tzu Chi Hospital

Taichung, Taichung, 427, Taiwan

Location

MeSH Terms

Interventions

danggui-shaoyao-san; Combined Modality Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Chia Ying Chuang, MD, MSc

CONTACT

+886-4-36060666; jiainwhh@gmail.com

Dian-Kun Li, MD,

CONTACT

+886-4-36060666; diankunli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this double-blind clinical trial, all participants, care providers, investigators, and outcomes assessors are masked to the group assignments. The study medications (Danggui Shaoyao San, Cuscuta Chinensis, combination therapy, and placebo) are prepared in identical medication containers with no distinguishable labeling. Randomization is conducted using a block randomization scheme, and the allocation sequence is securely managed by the study pharmacy. Neither the study team nor the participants have access to the randomization code until the trial concludes. This ensures unbiased treatment administration and assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Department of Chinese Medicine, Taichung Tzu Chi Hospital

Model Details: This study employs a randomized, double-blind, placebo-controlled, parallel assignment model. Participants are randomly allocated to one of four groups: Danggui Shaoyao San (DSS), Cuscuta Chinensis (Tu Si Zi), a combination of DSS and Tu Si Zi, or a placebo group. Each group receives its designated intervention throughout two consecutive menstrual cycles. The parallel design ensures that outcomes can be directly compared between groups without crossover, maintaining the integrity of the treatment effects. The double-blind approach minimizes bias by blinding both participants and investigators to group assignments.

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: December 12, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Start Date: Data will be available 6 months after the publication of primary results. End Date: Data will remain accessible for up to 5 years following publication.
• Access Criteria: Researchers seeking access must submit a written request to the study director, Chung Chia Ying, at jiainwhh@tzuchi.com.tw. Requests must include a detailed research proposal that specifies the intended use of the data and has received approval from an independent ethics review board. Access to the data will require signing a data use agreement, which includes terms to ensure the data are used solely for the proposed purposes and maintained confidentially.

Locations

TW (1)