primary dysmenorrhea
Conditions
Interventions
control group:Guizhi Fuling Capsule Placebo 0.58g/capsule 4 capsules/time bid po after meals
experimental group:Guizhi Fuling Capsule 0.58g/capsule 4 capsules/time bid po after meals
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: All of the following criteria must be met for inclusion in the trial: (1) Complies with primary dysmenorrhea diagnosis; (2) cold coagulation and blood stasis syndrome or not; (3) dysmenorrhea (NRS =1) for 3 days or more in the 3 menstrual cycles before screening and NRS =4 for abdominal pain for at least 2 days; (4) Dysmenorrhea (NRS score =1) was recorded on diary card for at least 3 days during lead-in period and NRS score =4 for abdominal pain was recorded for at least 2 days; (5) Regularity of menstrual cycle (change between cycles <7 days) in 3 menstrual cycles before screening and in lead-in period cycle is 21-35 days menstrual period is 3-7 days; (6) agree not to use analgesic emergency drugs other than ibuprofen during the trial period; (7) agree not to use oral contraceptives during the trial period (from screening visit to trial exit visit); (8) Women aged 18 to 35 years (inclusive); (9) Voluntary participation in this clinical trial informed consent and signing of informed consent form.
Exclusion criteria
Exclusion criteria: All of the following criteria must not be met for inclusion in the trial: (1) Secondary dysmenorrhea caused by endometriosis adenomyosis pelvic inflammatory disease uterine fibroids>5cm ovarian cysts>5cm congenital anatomical abnormalities or other pelvic diseases; (2) History of abortion colposcopy colposcopy biopsy etc. leading to dysmenorrhea (except if it does not lead to secondary dysmenorrhea and does not affect the evaluation of curative effect); (3) Use of traditional Chinese medicine preparations with the effects of activating blood circulation removing blood stasis and eliminating symptoms within one month before screening; (4) renal function index SCr> upper limit of normal reference value liver function index (ALT or AST) =1.5 times upper limit of normal reference value; (5) Use of injectable or subcutaneously implanted long-acting contraceptives within 6 months prior to screening or use of contraceptives within 8 weeks or use of pharmaceutical intrauterine devices; (6) complicated with serious primary diseases such as heart brain lung liver kidney nervous system hematopoietic system and digestive system; (7) mental retardation or mental illness or neurosis; (8) Suspected or true history of alcohol and drug abuse; (9) Known or suspected history of allergy to the components of the investigational drug and its excipients; (10) Allergy or contraindication to emergency medication ibuprofen capsules; (11) Pregnant or lactating women who are unable to use contraception during the trial and who have pregnancy plans within 3 months after the end of the trial; (12) Participation in any other interventional clinical trial within the last 3 months; (13) The investigator does not consider it appropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate at 3rd menstrual cycle after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain disappearance rate of dysmenorrhea;TCM syndrome integral and TCM syndrome curative effect evaluation;Duration of painful dysmenorrhea;Proportion of subjects with NRS score <4 for the most painful degree of dysmenorrhea;Use of emergency drugs;Patient-reported outcome scores;Duration of moderate to severe menstrual pain (NRS score =4);Response rates at cycles 1 2 4 and 5 after treatment versus cycle 1 after discontinuation;CMSS score;NRS score of dysmenorrhea; | — |
Countries
China
Contacts
Public ContactZhang Qinhua
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed