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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-22

Study Completion Date

2020-06-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Primary Dysmenorrhea Traditional Chinese Medicine Light

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One fourth of participants will receive Ding Kun Dan Pills, one fourth of participants will receive Simulated drug of DING KUN DAN Pills, one fourth of participants will receive MARVELON ,and the another fourth will receive low level light therapy

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

double blind

Study Groups

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DING KUN DAN

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

Group Type EXPERIMENTAL

DING KUN DAN

Intervention Type DRUG

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

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

Group Type PLACEBO_COMPARATOR

Simulated drug of DING KUN DAN

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

low level light therapy

Intervention Type DEVICE

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

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

Group Type ACTIVE_COMPARATOR

Marvelon

Intervention Type DRUG

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

Interventions

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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 Type DEVICE

DING KUN DAN

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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

16 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No