Traditional Chinese Medicine, Western Medicine and Low-level Light Therapy（LLLT） for Primary Dysmenorrhea（PD）

Clinical and Systematic Biology Study of Traditional Chinese Medicine, Western Medicine and Low-level Light Therapy for Primary

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

Study Overview

• Status: Unknown
• Conditions: Primary Dysmenorrhea; Traditional Chinese Medicine; Light
• Intervention / Treatment: Drug: DING KUN DAN; Drug: Simulated drug of DING KUN DAN; Device: low level light therapy; Drug: Marvelon

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.

• Study Type: Interventional
• Enrollment (Anticipated): 480
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xiao Ma, B.S.; Phone Number: #86 18810711533; Email: doctor_max@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Xiao MA
      • Contact: Xiao Ma, B.S.; Phone Number: +86 18810711533; Email: doctor_max@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Female (16-35 years old);
2. regular Menstruation (cycle 21-35 days, menstrual period 3-7 days);
3. Be clinically diagnosed with primary dysmenorrhea;
4. Be willing to participate in the whole process of the research in 5 consecutive menstrual cycles.

Exclusion Criteria:

1. irregular menstruation affecting the treatment and efficacy judgment;
2. Patients with secondary dysmenorrhea;
3. Those who have used related drugs in the past 3 months;
4. Abuse or dependence on substances (alcohol or medicine) in the past 3 months; heavy smokers (smokers who smoke 20 or more cigarettes per day);
5. 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;
6. Lactating or pregnant women, or women within 1 year after delivery;
7. Those who are allergic to the test drug or light, have contraindications for Marvelon and Ding kun dan;
8. Have a history of thromboembolic disease or a tendency to thrombosis;
9. one month before joining in this study (first interview), Who participated in another clinical trial;
10. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DING KUN DAN; DING KUN DAN,3.5g BID for 10 days (starting 3-5 days before menstruation) *3 menstrual cycle	Drug: DING KUN DAN; DING KUN DAN,3.5g BID for 10 days (starting 3-5 days before menstruation) *3 menstrual cycle
Placebo Comparator: 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	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
Experimental: 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	Device: 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
Active Comparator: 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	Drug: Marvelon; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale,VAS	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.	about 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-form McGill Pain Questionnaire-2, SF-MPQ-2	Short-form McGill Pain Questionnaire-2(SF-MPQ-2), By this scale, we can evaluate the different types of pain and the emotional effects of PD. It has 22 entries. These 22 entries include: Jumping pain, shooting pain, knife-like pain, sharp pain, cramping and dragging pain, constant biting pain, hot burning pain, sore pain, falling pain, slightly pressing pain, tearing pain, exhaustion - weakness, disgusting, fear, Torture - punishment, electric shock, cold pain, puncture pain, pain caused by gentle touch, itching, pin and needles pain, numbness. Each entry scored "0~10" points, the minimum score is 0,the maximum score is 10,a total of 11 levels. "0" indicates that never have this pain or symptom, "10" represents that this pain or feel is severe,"1-9" indicates different degrees of this type of pain or symptom. At last, Calculate the total score of all 22 items.	about 30 days
the COX menstrual symptom scale，CMSS	the COX menstrual symptom scale (CMSS), this score evaluate the level of PD from the two aspects of dysmenorrhea symptoms: the duration and severity , It has 17 entries including: cramps , nausea, vomiting, loss of appetite, headaches, backaches, leg aches, dizziness, weakness, diarrhea, facial blemishes, abdominal pain, flushing, general aching, depression, irritability, nervousness. Each entry scored "0~4" points, different score represents different duration or severity of corresponding symptoms : for the duration, 0 indicates never have this symptom, 1 means lasting less 3 hours, 2 means lasting 3~7 hours, 3 means 7~24 hours, 4 means more than 24 hours. as for the severity,0 indicates no pain; the mild is 1, the moderate is 2, the severity is 3, the extreme severity is 4. Then, Calculate the score of the duration and severity of all 17 items respectively, lastly, sum the total score of the duration and severity.	about 30 days
Menstrual flow graph analysis table	Through this form, we can know about the menstrual period and menstrual flow before and after treatment: Mild: blood stained area ≤ 1/3 of the entire sanitary napkin area; Moderate: blood stained area accounts for 1/3-3/5 of the entire sanitary napkin area; Severe: The blood stained area is basically the entire sanitary napkin. Blood clot area <1 dollar coin, which is a small blood clot; The blood clot area is ≥1 yuan coin, which is a large blood clot. fill in the number of sanitary napkins used in the appropriate space according to the degree of blood stain or the amount of the blood clot on each sanitary napkin discarded.	about 30 days
Uterine artery Pulsation index	Determination of uterine artery hemodynamics, can reflect the state of uterine blood circulation, the higher the uterine artery pulsation index, the decrease of blood flow, the lower the uterine artery pulsation index, the increase of blood flow or neo-vascularization	3 months
Uterine artery Resistance index	Determination of uterine artery hemodynamics, can reflect the state of uterine blood circulation, the higher the uterine artery resistance index, indicating less blood supply to uterine, the lower the uterine artery resistance index, the increased blood supply to uterine.	3 months
Uterine artery Systolic peak and diastolic peak ratio	The greater the ratio of uterine artery systolic peak to diastolic peak, indicating that the end-diastolic blood flow velocity is small and the peripheral resistance is large; conversely, the blood flow velocity is large and the peripheral resistance is small.	3 months

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Aijun SUN, MD, Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

Publications and helpful links

General Publications

• Zhu S, Ma X, Ding X, Gan J, Deng Y, Wang Y, Sun A. Comparative evaluation of low-level light therapy and ethinyl estradiol and desogestrel combined oral contraceptive for clinical efficacy and regulation of serum biochemical parameters in primary dysmenorrhoea: a prospective randomised multicentre trial. Lasers Med Sci. 2022 Jun;37(4):2239-2248. doi: 10.1007/s10103-021-03490-z. Epub 2022 Jan 14.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 22, 2019
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: April 14, 2019
• First Submitted That Met QC Criteria: May 15, 2019
• First Posted (Actual): May 17, 2019

Study Record Updates

• Last Update Posted (Actual): June 25, 2019
• Last Update Submitted That Met QC Criteria: June 21, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: traditional Chinese medicine; Primary Dysmenorrhea; low-level light therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Progestins; Desogestrel
• Other Study ID Numbers: PD201903

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Network platform, and the website will be attached later.
• IPD Sharing Time Frame: Within six months after the trial complete
• IPD Sharing Access Criteria: Data access requests will be reviewed by an external independent review panel.Requestors will be required to sign a Data Access Agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No