Pelvic inflammatory disease
Conditions
Interventions
Experimental group:Danbai granules 1 bag/time, 3 times/day
Control group:Danbai granule simulation agent 1 bag/time, 3 times/day
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria at the same time: 1. Meet the diagnosis of pelvic inflammatory disease sequelae, and the course of the disease > 6 months; 2. Women aged 18 to 55 years (including 18 years old and 55 years old per week) have a history of sexual life; 3. The average pain VAS score in the week before enrollment >= 3 points; 4. Female patients with basic rules of the menstrual cycle (menstrual cycle of 21-35 days, menstrual period of 3-10 days); 5. TCM dialectics belong to damp heat stasis; 6. Have the ability to cooperate with the observation of efficacy and adverse events, as well as record the subject day reporter; 7. Informed consent and voluntary participation in this clinical trial, signed informed consent.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria are excluded: 1. Acute pelvic inflammatory diseases or acute onset of chronic pelvic inflammatory diseases; 2. Those who have been confirmed by examination to have gynecological malignant tumors, benign tumors (of which the maximum diameter of uterine fibroids is greater than 3 cm, and submucosal fibroids), specific vaginitis (trichomoniasis vaginitis, fungal vaginitis, chlamydia vaginitis, gonococcal vaginitis), acute cervicitis, endometriosis, myometriosis, pelvic venous congestion, tuberculous pelvic inflammatory disease, abnormal uterine bleeding and other diseases caused by related symptoms; 3. Insertion of an IUD in the past 3 months; Absence of uterus and bilateral appendages; 4. Users who take painkillers for a long time or excessive painkillers (take painkillers for more than 10 days within 1 month); 5 Have received relevant treatment or taken drugs with similar functional indications within 1 month before screening; 6. Patients with severe heart, lung, brain and hematopoietic system diseases, malignant tumors; 7. Those with related symptoms caused by anxiety, depression, etc. (depression scale and anxiety scale >= 5 points); 8. Persons with intellectual disabilities or mental illnesses; 9. Suspected or indeed have a history of smoking, alcohol or drug abuse; 10. Positive pregnancy test, pregnant or lactating women, and those with pregnancy plans in the past 4 months; 11. Those who are allergic to the constitution and are known to be allergic to the constituent components of the drug; 12. Screening those who have participated in other clinical trials within 3 months before screening; 13. Researchers who do not believe that they are suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ultrasound/MRI;Pain Visual Analogue Scale (VAS) score;Local sign score;TCM syndrome score; | — |
Secondary
| Measure | Time frame |
|---|---|
| S-36 Health Questionnaire (Medical Outcomes Study Health Survey Short Form-36 Item);Self-rating Depression Scale;self-rating anxiety scale; | — |
Countries
China
Contacts
Public ContactZhang Tingting
Outcome results
None listed