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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 4

Conditions: Light; Traditional Chinese Medicine; Primary Dysmenorrhea

Treatments: Drug: Marvelon; Drug: DING KUN DAN; Drug: Simulated drug of DING KUN DAN; Device: low level light therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03953716

PD201903

Details and patient eligibility

About

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

Full 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.

Enrollment: 480 estimated patients

Sex: Female

Ages: 16 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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480 participants in 4 patient groups, including a placebo group

DING KUN DAN

Experimental group

Description:

DING KUN DAN,3.5g BID for 10 days (starting 3-5 days before menstruation) \*3 menstrual cycle

Treatment:

Drug: DING KUN DAN

Simulated drug of DING KUN DAN

Placebo Comparator group

Description:

Simulated drug of DING KUN DAN，3.5g BID for 10 days (starting 3-5 days before menstruation) \*3 menstrual cycle

Treatment:

Drug: Simulated drug of DING KUN DAN

low level light therapy

Experimental group

Description:

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

Treatment:

Device: low level light therapy

Marvelon

Active Comparator group

Description:

1 pill QD\*21 days (starting on the 5th day of menstruation, continuing the next cycle after 1 week of withdrawal) \*3 menstrual cycle

Treatment:

Drug: Marvelon