NCT03953716

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 16 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Dysmenorrhea
• Traditional Chinese Medicine
• Light

Interventions

Type	Name	Description
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
DRUG	DING KUN DAN	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
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

Timeline

• Start date: 2019-06-22
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2019-05-17
• Last updated: 2019-06-25

Locations

1 site across 1 country: China