Clinical and Systematic Biology Study of Traditional Chinese Medicine, Western Medicine and Low-level Light Therapy for Primary
试验速览
- 阶段
- 4 期
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale,VAS
研究概览
简要总结
To observe the clinical efficacy and safety of three methods for the treatment of primary dysmenorrhea. Establish an integrated biomarker index system for the evaluation of the efficacy of traditional Chinese medicine, western medicine and Low-level Light Therapy for the treatment of primary dysmenorrhea, and further explore the mechanism and therapeutic material basis of the three treatment methods for the treatment of primary dysmenorrhea
详细描述
480 women clinically diagnosed of primary dysmenorrhea will be enrolled from nationwide multi-centers. Blood samples were collected from 480 patients before and after treatment (1 experimental group, 3 control groups, treatment cycle of 3 menstrual cycles, follow-up cycle of 5 menstrual cycles), Metabonomics study, and integration of clinical sample information (Serum biochemical indicators, imaging indicators, etc.), through bioinformatics to establish a comprehensive biomarker index system for the evaluation of the efficacy of traditional Chinese medicine, Western medicine and Low-level Light Therapy instrument Methods for the treatment of primary dysmenorrhea and its therapeutic basis.
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
- Double (Participant, Investigator)
盲法说明
double blind
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female (16-35 years old);
- •regular Menstruation (cycle 21-35 days, menstrual period 3-7 days);
- •Be clinically diagnosed with primary dysmenorrhea;
- •Be willing to participate in the whole process of the research in 5 consecutive menstrual cycles.
排除标准
- •irregular menstruation affecting the treatment and efficacy judgment;
- •Patients with secondary dysmenorrhea;
- •Those who have used related drugs in the past 3 months;
- •Abuse or dependence on substances (alcohol or medicine) in the past 3 months; heavy smokers (smokers who smoke 20 or more cigarettes per day);
- •Those who have severe or unstable physical illnesses, related to liver, kidney, gastrointestinal tract, cardiovascular, respiratory, endocrine, nervous, immune or blood systems, neuropsychiatric systems and so on;
- •Lactating or pregnant women, or women within 1 year after delivery;
- •Those who are allergic to the test drug or light, have contraindications for Marvelon and Ding kun dan;
- •Have a history of thromboembolic disease or a tendency to thrombosis;
- •one month before joining in this study (first interview), Who participated in another clinical trial;
- •Those who meet the inclusion criteria, fail to follow the doctor's advice so that we cannot judge the curative effect ,the incomplete data cannot be evaluated.
研究组 & 干预措施
DING KUN DAN
DING KUN DAN,3.5g BID for 10 days (starting 3-5 days before menstruation) *3 menstrual cycle
干预措施: DING KUN DAN (Drug)
Simulated drug of DING KUN DAN
Simulated drug of DING KUN DAN，3.5g BID for 10 days (starting 3-5 days before menstruation) *3 menstrual cycle
干预措施: Simulated drug of DING KUN DAN (Drug)
low level light therapy
Start using low level light therapy after the menstrual period, once a day, every 20 minutes * 5 days ( one treatment cycle), start the next course at intervals of 2 days until the next menstruation
干预措施: low level light therapy (Device)
Marvelon
1 pill QD*21 days (starting on the 5th day of menstruation, continuing the next cycle after 1 week of withdrawal) *3 menstrual cycle
干预措施: Marvelon (Drug)
结局指标
主要结局
Visual Analogue Scale,VAS
时间窗: about 30 days
Visual Analogue Scale/Score (VAS): Draw a 10 cm horizontal line on the paper. The degree of pain is indicated by the line segment，One end of the horizontal line is 0, indicating no pain; the other end is 10, indicating severe pain; the middle part indicates different degrees of pain（the mild pain is 1-3, the moderate is 4-6, the severity is 7-9），The patient chooses the value that can represent the degree of pain.
次要结局
- Short-form McGill Pain Questionnaire-2, SF-MPQ-2(about 30 days)
- the COX menstrual symptom scale，CMSS(about 30 days)
- Menstrual flow graph analysis table(about 30 days)
- Uterine artery Pulsation index(3 months)
- Uterine artery Resistance index(3 months)
- Uterine artery Systolic peak and diastolic peak ratio(3 months)
研究者
Aijun Sun
Professor
Peking Union Medical College Hospital