Clinical and Systematic Biology Study of Traditional Chinese Medicine, Western Medicine and Low-level Light Therapy for Primary
Overview
- Phase
- Phase 4
- Intervention
- DING KUN DAN
- Conditions
- Primary Dysmenorrhea
- Sponsor
- Peking Union Medical College Hospital
- Enrollment
- 480
- Locations
- 1
- Primary Endpoint
- Visual Analogue Scale,VAS
- Last Updated
- 6 years ago
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Aijun Sun
Professor
Peking Union Medical College Hospital
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
DING KUN DAN
DING KUN DAN,3.5g BID for 10 days (starting 3-5 days before menstruation) \*3 menstrual cycle
Intervention: DING KUN DAN
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
Intervention: Simulated drug of DING KUN DAN
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
Intervention: low level light therapy
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
Intervention: Marvelon
Outcomes
Primary Outcomes
Visual Analogue Scale,VAS
Time Frame: 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.
Secondary Outcomes
- 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)