A Preliminary Study on the Efficacy of Danggui Shaoyao San and Cuscuta Chinensis in Patients with Primary Dysmenorrhea
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity Measured by the Visual Analogue Scale (VAS)
研究概览
简要总结
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.
详细描述
Study Overview This study investigates the efficacy of two traditional Chinese medicine (TCM) formulations, Danggui Shaoyao San (DSS) and Cuscuta Chinensis (Tu Si Zi), in managing primary dysmenorrhea (PD). PD is a prevalent condition characterized by painful menstrual cramps, often accompanied by physical and emotional symptoms such as fatigue, irritability, nausea, and breast tenderness. Existing treatment options, including NSAIDs and hormonal contraceptives, are effective for symptom relief but may cause side effects or fail to address associated non-pain symptoms, emphasizing the need for complementary or alternative therapies.
Study Design The trial is a randomized, double-blind, placebo-controlled study. Participants meeting the inclusion criteria will be randomly assigned to one of four groups: DSS, Tu Si Zi, a combination of DSS and Tu Si Zi, or placebo. Each treatment will be administered 3 to 7 days prior to menstruation and continued until 3 days post-menstruation. The intervention spans two consecutive menstrual cycles.
The primary outcomes will be changes in pain intensity measured by the Visual Analogue Scale (VAS) and improvements in menstrual symptoms evaluated using the Menstrual Symptom Questionnaire (MSQ). Secondary outcomes include an exploration of the correlation between TCM pulse diagnosis, TCM constitution types, and therapeutic responses, providing insights into the personalization of treatment based on TCM differentiation (辨證).
Rationale Danggui Shaoyao San, a classic TCM formula, is widely used for blood and qi regulation, reducing uterine contractions, and alleviating menstrual pain. Research suggests that it has anti-inflammatory properties and supports immune regulation, making it suitable for patients with blood stasis and qi stagnation patterns. Conversely, Cuscuta Chinensis, traditionally used to nourish kidney essence and yang, may be effective for individuals with kidney deficiency patterns associated with PD. The combination of these formulas could potentially enhance therapeutic outcomes by addressing multiple pathophysiological mechanisms simultaneously.
Methods Eligible participants are women aged 20-45 years with regular menstrual cycles (21-42 days) and a history of moderate to severe menstrual pain (VAS > 3) persisting for at least three cycles. Participants will be excluded if they have secondary dysmenorrhea caused by underlying conditions (e.g., endometriosis), use intrauterine devices, are pregnant or breastfeeding, or are taking anticoagulants or other conflicting medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Danggui Shaoyao San
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.
干预措施: Danggui Shaoyao San (DSS) (Drug)
Cuscuta Chinensis
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.
干预措施: Cuscuta Chinensis (Tu Si Zi) (Drug)
Danggui Shaoyao San + Cuscuta Chinensis
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.
干预措施: Combination Therapy (DSS + Tu Si Zi) (Drug)
Placebo
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Pain Intensity Measured by the Visual Analogue Scale (VAS)
时间窗: Baseline and after two menstrual cycles (approximately 8 weeks)
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.
次要结局
- 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))
研究者
Chia-Ying Chuang
Attending Physician, Department of Chinese Medicine, Taichung Tzu Chi Hospital
Taichung Tzu Chi Hospital