Early unexplained recurrent abortion
Conditions
Interventions
Treatment group:bushen huoxue prescription+Duphaston+Aspirin
Control group:Traditional Chinese medicine mimetic+Aspirin+Duphaston
Sponsors
Yueyang integrated traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: (1) Aged = 20 and = 40 married female; (2) At the same time the following shall be met: a. Diagnostic criteria of Western Medicine According to the diagnosis of early unexplained recurrent abortion in the fifth edition of Obstetrics and Gynecology (edited by Le Jie) and the Chinese expert consensus on the diagnosis and treatment of spontaneous abortion (2020 Edition) of the national higher medical colleges and Universities: 1) Spontaneous abortion occurred for 2 or more consecutive times within 12 weeks 2) There was no genetic disease in the couple and no abnormality was found in the karyotype analysis 3) Female genital tract anatomy was normal 4) Reproductive endocrine thyroid and other endocrine indicators were normal; Antisperm antibody endometrial antibody anticardiolipin antibody and anti-ovarian antibody were normal 5) No mycoplasma chlamydia and virus infections 6) Semen examination of the man showed no abnormality b. Dialectical basis of traditional Chinese medicine -- kidney deficiency and blood stasis syndrome According to the guiding principles for clinical research of new drugs of traditional Chinese medicine and Gynecology of traditional Chinese medicine the diagnostic criteria for kidney deficiency and blood stasis type are formulated: Main symptoms: 1) repeated pregnancies and repeated abortions for 2 or more consecutive times; 2) Slight abdominal discomfort; 3) Low back pain. Secondary symptoms: 1) sore and soft knees 2) dark complexion 3) dizziness and tinnitus 4) nocturnal urine frequency 5) decreased sexual desire 6) previous menstrual volume and dark color. Tongue pulse: the tongue is pale with white fur or dark purple there are petechiae or ecchymosis spots on the edge of the tongue the pulse is thin smooth or astringent or the ulnar pulse is weak. The main symptom is necessary. If there are 2 or more secondary symptoms and 1 tongue and pulse the diagnosis can be made. Understand and agree to participate in this study and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Chromosomal abnormalities in both husband and wife; Anatomical abnormalities of the female reproductive organs (such as uterine fibroids mediastinal uterus bicornuate uterus cervical insufficiency etc.); Microbial infection factors (such as Toxoplasma gondii cytomegalovirus herpes simplex rubella virus chlamydia etc.); Endocrine abnormalities in the woman (such as polycystic ovary syndrome hyperthyroidism or hypothyroidism etc.); Immune diseases (such as blocking antibody antisperm antibody abnormal anti endometrial antibody etc.); The sperm of the man was abnormal. (2) The liver and kidney function examination electrocardiogram chest X-ray blood and urine routine of both husband and wife were abnormal. (3) In the past three months, relevant treatments, such as anticoagulant or fibrinolytic drugs, were used, which made it difficult to judge the curative effect. (4) Have a history of allergy to the drugs used in the treatment. (5) Patients who are participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pass rate at 12 weeks of gestation; | — |
Secondary
| Measure | Time frame |
|---|---|
| IL-17;Clinical total effective rate at 12 weeks of gestation;Th17/treg cell ratio;coagulation;HMGB1;Foxp3;TCM syndrome score; | — |
Countries
China
Contacts
Public Contacthuangsiqing
Yueyang integrated traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of traditional Chinese Medicine
Outcome results
None listed