Primary DysmenorrheaPhase 4NCT03953716
Traditional Chinese Medicine, Western Medicine and Low-level Light Therapy（LLLT） for Primary Dysmenorrhea（PD）
A Phase 4 study testing low level light therapy, DING KUN DAN and Simulated drug of DING KUN DAN in people with Primary Dysmenorrhea and Traditional Chinese Medicine, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 35 years, women only
- Conditions the study is for
- Primary Dysmenorrhea, Traditional Chinese Medicine, Light
- What is being tested?
- low level light therapy, DING KUN DAN and Simulated drug of DING KUN DAN
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 22 Jun 2019to 30 Jun 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiao MA
Beijing, Beijing Municipality, 100000
Xiao Ma, B.S., 18810711533 ext. +86, doctor_max@sina.com
About this study
Official title: Clinical and Systematic Biology Study of Traditional Chinese Medicine, Western Medicine and Low-level Light Therapy for Primary
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
Read the 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
- Being tested
- low level light therapy, DING KUN DAN, Simulated drug of DING KUN DAN, Marvelon
- Keywords
- Primary Dysmenorrhea, traditional Chinese medicine, low-level light therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low level light therapyDevice
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
DING KUN DANDrug
DING KUN DAN,3.5g BID for 10 days (starting 3-5 days before menstruation) *3 menstrual cycle
Simulated drug of DING KUN DANDrug
Simulated drug of DING KUN DAN，3.5g BID for 10 days (starting 3-5 days before menstruation) *3 menstrual cycle
MarvelonDrug
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
| Study group | Role | What they receive |
|---|---|---|
| DING KUN DAN | Experimental | DING KUN DAN,3.5g BID for 10 days (starting 3-5 days before menstruation) *3 menstrual cycle Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Marvelon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: about 30 days
Secondary outcomes (6)
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.
Measured: about 30 days
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.
Measured: about 30 days
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.
Measured: about 30 days
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
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start22 Jun 2019 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aijun Sun, Peking Union Medical College Hospital
- Investigators
- Aijun SUN, MD, Principal investigator, Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953716
- Sponsor's protocol ID
- PD201903
- Status last verified
- Jun 2019
- First submitted
- 14 Apr 2019
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Network platform, and the website will be attached later.
Publications
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.
PubMed 35028764
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Systematic Biology Study of Traditional Chinese Medicine, Western Medicine and Low-level Light Therapy for Primary
- ClinicalTrials.gov ID
- NCT03953716
- Acronym / sponsor ID
- PD201903
- Conditions
- Primary Dysmenorrhea, Traditional Chinese Medicine, Light
- Keywords
- Primary Dysmenorrhea, traditional Chinese medicine, low-level light therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 22 Jun 2019 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 17 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| DING KUN DAN | Experimental | Drug: DING KUN DANDING KUN DAN,3.5g BID for 10 days (starting 3-5 days before menstruation) *3 menstrual cycle |
| Simulated drug of DING KUN DAN | Placebo comparator | Drug: Simulated drug of DING KUN DANSimulated drug of DING KUN DAN，3.5g BID for 10 days (starting 3-5 days before menstruation) *3 menstrual cycle |
| low level light therapy | Experimental | Device: low level light therapyStart 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 | Active comparator | Drug: Marvelon1 pill QD*21 days (starting on the 5th day of menstruation, continuing the next cycle after 1 week of withdrawal) *3 menstrual cycle |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low level light therapyStart 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 |
| DING KUN DANDING 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 DANSimulated 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 |
| MarvelonMarvelon 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 |
Primary outcome
Visual Analogue Scale,VAS
Time frame: about 30 days
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.
6 secondary outcomes
Short-form McGill Pain Questionnaire-2, SF-MPQ-2
Time frame: about 30 days
the COX menstrual symptom scale，CMSS
Time frame: about 30 days
Menstrual flow graph analysis table
Time frame: about 30 days
Uterine artery Pulsation index
Time frame: 3 months
Uterine artery Resistance index
Time frame: 3 months
Uterine artery Systolic peak and diastolic peak ratio
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Derived from this study: PubMed 35028764Zhu 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.
- Individual participant dataSharing planned: Yes. Network platform, and the website will be attached later.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aijun SUN, MD principal investigator
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing low level light therapy, DING KUN DAN and Simulated drug of DING KUN DAN in people with Primary Dysmenorrhea and Traditional Chinese Medicine, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao Ma, B.S. (18810711533 ext. #86, doctor_max@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale,VAS (time frame: about 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03953716, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019.