| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Primary Dysmenorrhea Traditional Chinese Medicine Light | Device: low level light therapy Drug: DING KUN DAN Drug: Simulated drug of DING KUN DAN Drug: Marvelon | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 480 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention 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 (Participant, Investigator) |
| Masking Description: | double blind |
| Primary Purpose: | Treatment |
| Official Title: | Clinical and Systematic Biology Study of Traditional Chinese Medicine, Western Medicine and Low-level Light Therapy for Primary |
| Estimated Study Start Date : | June 22, 2019 |
| Estimated Primary Completion Date : | June 30, 2020 |
| Estimated Study Completion Date : | June 30, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: DING KUN DAN
DING KUN DAN,3.5g BID for 10 days (starting 3-5 days before menstruation) *3 menstrual cycle
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Drug: DING KUN DAN
DING KUN DAN,3.5g BID for 10 days (starting 3-5 days before menstruation) *3 menstrual cycle
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Placebo Comparator: 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
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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
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Experimental: 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
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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
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Active Comparator: 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
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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
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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.
| Ages Eligible for Study: | 16 Years to 35 Years (Child, Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Xiao Ma, B.S. | 18810711533 ext #86 | doctor_max@sina.com |
| China, Beijing | |
| Xiao MA | Recruiting |
| Beijing, Beijing, China, 100000 | |
| Contact: Xiao Ma, B.S. 18810711533 ext +86 doctor_max@sina.com | |
| Principal Investigator: | Aijun SUN, MD | Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences |
| Tracking Information | |||||||||||||||||
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| First Submitted Date ICMJE | April 14, 2019 | ||||||||||||||||
| First Posted Date ICMJE | May 17, 2019 | ||||||||||||||||
| Last Update Posted Date | June 25, 2019 | ||||||||||||||||
| Estimated Study Start Date ICMJE | June 22, 2019 | ||||||||||||||||
| Estimated Primary Completion Date | June 30, 2020 (Final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | |||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Traditional Chinese Medicine, Western Medicine and Low-level Light Therapy(LLLT) for Primary Dysmenorrhea(PD) | ||||||||||||||||
| Official Title ICMJE | Clinical and Systematic Biology Study of Traditional Chinese Medicine, Western Medicine and Low-level Light Therapy for Primary | ||||||||||||||||
| 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. | ||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Phase ICMJE | Phase 4 | ||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention 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 (Participant, Investigator)Masking Description: double blind Primary Purpose: Treatment
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Unknown status | ||||||||||||||||
| Estimated Enrollment ICMJE |
480 | ||||||||||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||
| Estimated Study Completion Date ICMJE | June 30, 2020 | ||||||||||||||||
| Estimated Primary Completion Date | June 30, 2020 (Final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 16 Years to 35 Years (Child, Adult) | ||||||||||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Listed Location Countries ICMJE | China | ||||||||||||||||
| Removed Location Countries | |||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT03953716 | ||||||||||||||||
| Other Study ID Numbers ICMJE | PD201903 | ||||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Aijun Sun, Peking Union Medical College Hospital | ||||||||||||||||
| Study Sponsor ICMJE | Peking Union Medical College Hospital | ||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||
| Investigators ICMJE |
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| PRS Account | Peking Union Medical College Hospital | ||||||||||||||||
| Verification Date | June 2019 | ||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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