UnknownPhase 4

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

China480 participantsStarted 2019-06-22

Plain-language 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

Who can participate

Age range16 Years – 35 Years

SexFEMALE

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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;

What they're measuring

Visual Analogue Scale,VAS

Timeframe: about 30 days

Trial details

NCT IDNCT03953716

SponsorPeking Union Medical College Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-30

Contact for this trial

Xiao Ma, B.S.

18810711533 doctor_max@sina.com

View on ClinicalTrials.gov More Primary Dysmenorrhea trials