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

NCT03953716 | Unknown Phase 4 DMC

• 1 other identifier: PD201903
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Primary Dysmenorrhea; Traditional Chinese Medicine; Light

Keywords

Primary Dysmenorrhea; traditional Chinese medicine; low-level light therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Short-form McGill Pain Questionnaire-2, SF-MPQ-2

  about 30 days

• the COX menstrual symptom scale，CMSS

  about 30 days

• Menstrual flow graph analysis table

  about 30 days

• Uterine artery Pulsation index

  3 months

• Uterine artery Resistance index

  3 months

Study Arms (4)

DING KUN DAN

EXPERIMENTAL

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

Drug: DING KUN DAN

Simulated drug of DING KUN DAN

PLACEBO COMPARATOR

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

low level light therapy

EXPERIMENTAL

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

Marvelon

ACTIVE COMPARATOR

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

Interventions

low level light therapy 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

low level light therapy

DING KUN DAN DRUG

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

DING KUN DAN

Simulated drug of DING KUN DAN DRUG

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

Simulated drug of DING KUN DAN

Marvelon 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

Marvelon

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• one month before joining in this study (first interview), Who participated in another clinical trial;

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Xiao MA

Beijing, Beijing Municipality, 100000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 35028764 DERIVED

MeSH Terms

Interventions

Low-Level Light Therapy; Desogestrel

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Aijun SUN, MD

  Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao Ma, B.S.

CONTACT

18810711533; doctor_max@sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: April 14, 2019
• First Posted: May 17, 2019
• Study Start: June 22, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: June 25, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: Within six months after the trial complete
• Access Criteria: Data access requests will be reviewed by an external independent review panel.Requestors will be required to sign a Data Access Agreement.

Locations

CN (1)