search
Back to results

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

Primary Purpose

Primary Dysmenorrhea, Traditional Chinese Medicine, Light

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
low level light therapy
DING KUN DAN
Simulated drug of DING KUN DAN
Marvelon
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring Primary Dysmenorrhea, traditional Chinese medicine, low-level light therapy

Eligibility Criteria

16 Years - 35 Years (Child, Adult)FemaleDoes not accept 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.

Sites / Locations

  • Xiao MARecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Active Comparator

Arm Label

DING KUN DAN

Simulated drug of DING KUN DAN

low level light therapy

Marvelon

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Short-form McGill Pain Questionnaire-2, SF-MPQ-2
Short-form McGill Pain Questionnaire-2(SF-MPQ-2), By this scale, we can evaluate the different types of pain and the emotional effects of PD. It has 22 entries. These 22 entries include: Jumping pain, shooting pain, knife-like pain, sharp pain, cramping and dragging pain, constant biting pain, hot burning pain, sore pain, falling pain, slightly pressing pain, tearing pain, exhaustion - weakness, disgusting, fear, Torture - punishment, electric shock, cold pain, puncture pain, pain caused by gentle touch, itching, pin and needles pain, numbness. Each entry scored "0~10" points, the minimum score is 0,the maximum score is 10,a total of 11 levels. "0" indicates that never have this pain or symptom, "10" represents that this pain or feel is severe,"1-9" indicates different degrees of this type of pain or symptom. At last, Calculate the total score of all 22 items.
the COX menstrual symptom scale，CMSS
the COX menstrual symptom scale (CMSS), this score evaluate the level of PD from the two aspects of dysmenorrhea symptoms: the duration and severity , It has 17 entries including: cramps , nausea, vomiting, loss of appetite, headaches, backaches, leg aches, dizziness, weakness, diarrhea, facial blemishes, abdominal pain, flushing, general aching, depression, irritability, nervousness. Each entry scored "0~4" points, different score represents different duration or severity of corresponding symptoms : for the duration, 0 indicates never have this symptom, 1 means lasting less 3 hours, 2 means lasting 3~7 hours, 3 means 7~24 hours, 4 means more than 24 hours. as for the severity,0 indicates no pain; the mild is 1, the moderate is 2, the severity is 3, the extreme severity is 4. Then, Calculate the score of the duration and severity of all 17 items respectively, lastly, sum the total score of the duration and severity.
Menstrual flow graph analysis table
Through this form, we can know about the menstrual period and menstrual flow before and after treatment: Mild: blood stained area ≤ 1/3 of the entire sanitary napkin area; Moderate: blood stained area accounts for 1/3-3/5 of the entire sanitary napkin area; Severe: The blood stained area is basically the entire sanitary napkin. Blood clot area <1 dollar coin, which is a small blood clot; The blood clot area is ≥1 yuan coin, which is a large blood clot. fill in the number of sanitary napkins used in the appropriate space according to the degree of blood stain or the amount of the blood clot on each sanitary napkin discarded.
Uterine artery Pulsation index
Determination of uterine artery hemodynamics, can reflect the state of uterine blood circulation, the higher the uterine artery pulsation index, the decrease of blood flow, the lower the uterine artery pulsation index, the increase of blood flow or neo-vascularization
Uterine artery Resistance index
Determination of uterine artery hemodynamics, can reflect the state of uterine blood circulation, the higher the uterine artery resistance index, indicating less blood supply to uterine, the lower the uterine artery resistance index, the increased blood supply to uterine.
Uterine artery Systolic peak and diastolic peak ratio
The greater the ratio of uterine artery systolic peak to diastolic peak, indicating that the end-diastolic blood flow velocity is small and the peripheral resistance is large; conversely, the blood flow velocity is large and the peripheral resistance is small.

Full Information

First Posted
April 14, 2019
Last Updated
June 21, 2019
Sponsor
Peking Union Medical College Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03953716
Brief Title
Traditional Chinese Medicine, Western Medicine and Low-level Light Therapy（LLLT） for Primary Dysmenorrhea（PD）
Official Title
Clinical and Systematic Biology Study of Traditional Chinese Medicine, Western Medicine and Low-level Light Therapy for Primary
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 22, 2019 (Anticipated)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea, Traditional Chinese Medicine, Light
Keywords
Primary Dysmenorrhea, traditional Chinese medicine, low-level light therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
ParticipantInvestigator
Masking Description
double blind
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DING KUN DAN
Arm Type
Experimental
Arm Description
DING KUN DAN,3.5g BID for 10 days (starting 3-5 days before menstruation) *3 menstrual cycle
Arm Title
Simulated drug of DING KUN DAN
Arm Type
Placebo Comparator
Arm Description
Simulated drug of DING KUN DAN，3.5g BID for 10 days (starting 3-5 days before menstruation) *3 menstrual cycle
Arm Title
low level light therapy
Arm Type
Experimental
Arm 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
Arm Title
Marvelon
Arm Type
Active Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
low level light therapy
Intervention 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
Intervention Type
Drug
Intervention Name(s)
DING KUN DAN
Intervention Description
DING KUN DAN,3.5g BID for 10 days (starting 3-5 days before menstruation) *3 menstrual cycle
Intervention Type
Drug
Intervention Name(s)
Simulated drug of DING KUN DAN
Intervention Description
Simulated drug of DING KUN DAN，3.5g BID for 10 days (starting 3-5 days before menstruation) *3 menstrual cycle
Intervention Type
Drug
Intervention Name(s)
Marvelon
Intervention Description
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
Primary Outcome Measure Information:
Title
Visual Analogue Scale,VAS
Description
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.
Time Frame
about 30 days
Secondary Outcome Measure Information:
Title
Short-form McGill Pain Questionnaire-2, SF-MPQ-2
Description
Short-form McGill Pain Questionnaire-2(SF-MPQ-2), By this scale, we can evaluate the different types of pain and the emotional effects of PD. It has 22 entries. These 22 entries include: Jumping pain, shooting pain, knife-like pain, sharp pain, cramping and dragging pain, constant biting pain, hot burning pain, sore pain, falling pain, slightly pressing pain, tearing pain, exhaustion - weakness, disgusting, fear, Torture - punishment, electric shock, cold pain, puncture pain, pain caused by gentle touch, itching, pin and needles pain, numbness. Each entry scored "0~10" points, the minimum score is 0,the maximum score is 10,a total of 11 levels. "0" indicates that never have this pain or symptom, "10" represents that this pain or feel is severe,"1-9" indicates different degrees of this type of pain or symptom. At last, Calculate the total score of all 22 items.
Time Frame
about 30 days
Title
the COX menstrual symptom scale，CMSS
Description
the COX menstrual symptom scale (CMSS), this score evaluate the level of PD from the two aspects of dysmenorrhea symptoms: the duration and severity , It has 17 entries including: cramps , nausea, vomiting, loss of appetite, headaches, backaches, leg aches, dizziness, weakness, diarrhea, facial blemishes, abdominal pain, flushing, general aching, depression, irritability, nervousness. Each entry scored "0~4" points, different score represents different duration or severity of corresponding symptoms : for the duration, 0 indicates never have this symptom, 1 means lasting less 3 hours, 2 means lasting 3~7 hours, 3 means 7~24 hours, 4 means more than 24 hours. as for the severity,0 indicates no pain; the mild is 1, the moderate is 2, the severity is 3, the extreme severity is 4. Then, Calculate the score of the duration and severity of all 17 items respectively, lastly, sum the total score of the duration and severity.
Time Frame
about 30 days
Title
Menstrual flow graph analysis table
Description
Through this form, we can know about the menstrual period and menstrual flow before and after treatment: Mild: blood stained area ≤ 1/3 of the entire sanitary napkin area; Moderate: blood stained area accounts for 1/3-3/5 of the entire sanitary napkin area; Severe: The blood stained area is basically the entire sanitary napkin. Blood clot area <1 dollar coin, which is a small blood clot; The blood clot area is ≥1 yuan coin, which is a large blood clot. fill in the number of sanitary napkins used in the appropriate space according to the degree of blood stain or the amount of the blood clot on each sanitary napkin discarded.
Time Frame
about 30 days
Title
Uterine artery Pulsation index
Description
Determination of uterine artery hemodynamics, can reflect the state of uterine blood circulation, the higher the uterine artery pulsation index, the decrease of blood flow, the lower the uterine artery pulsation index, the increase of blood flow or neo-vascularization
Time Frame
3 months
Title
Uterine artery Resistance index
Description
Determination of uterine artery hemodynamics, can reflect the state of uterine blood circulation, the higher the uterine artery resistance index, indicating less blood supply to uterine, the lower the uterine artery resistance index, the increased blood supply to uterine.
Time Frame
3 months
Title
Uterine artery Systolic peak and diastolic peak ratio
Description
The greater the ratio of uterine artery systolic peak to diastolic peak, indicating that the end-diastolic blood flow velocity is small and the peripheral resistance is large; conversely, the blood flow velocity is large and the peripheral resistance is small.
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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; one month before joining in this study (first interview), Who participated in another clinical trial; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao Ma, B.S.
Phone
18810711533
Ext
#86
Email
doctor_max@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aijun SUN, MD
Organizational Affiliation
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiao MA
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao Ma, B.S.
Phone
18810711533
Ext
+86
Email
doctor_max@sina.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Network platform, and the website will be attached later.
IPD Sharing Time Frame
Within six months after the trial complete
IPD Sharing Access Criteria
Data access requests will be reviewed by an external independent review panel.Requestors will be required to sign a Data Access Agreement.
Citations:
PubMed Identifier
35028764
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs