Recurrent urinary tract infections
Conditions
Interventions
High dose group:Chaiqin Tong Linpian, 6 tablets/time, 3 times/day, taken with warm water.
Low dose group:Chaiqin Tong Linpian, 4 tablets/time, 3 times/day+Chaiqin Tong Linpian Simulator, 2 tablets/time, 3 times/day, taken with warm water.
placebo group:Chaiqin Tong Linpian Simulator, 6 tablets/time, 3 times/day, delivered with warm water.
Sponsors
Guang'anmen Hospital, Chinese Academy of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Meets the clinical diagnostic criteria for acute lower urinary tract infection (with clinical symptoms such as frequent urination, urgency, and pain during urination, and white blood cells>5/HP on urine sediment microscopy can be included in the study); (2) Screening for urinary tract infections occurring = 2 times within the first 6 months, or = 3 times within 1 year (including this acute infection); (3) Traditional Chinese Medicine (TCM) syndrome differentiation belongs to the syndrome of liver meridian qi stagnation, dampness heat accumulation and lower jiao; (4) Women aged between 18 and 70 years (including both ends); (5) Voluntarily participate in this clinical trial and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: (1) The combination of upper urinary tract infections, urinary tuberculosis, gonorrhea and other diseases that affect clinical efficacy evaluation; (2) When complicated with systemic infection or screening, researchers believe that urinary tract infection requires intravenous antibiotic treatment; (3) Severe urinary tract anatomical abnormalities, urinary tract obstruction caused by stones, bladder diverticulum, urinary system tumors, uremia, and after organ transplantation; (4) A history of urinary tract infections caused by mycoplasma, chlamydia, fungi, parasites, etc. within the past year; (5) Taking traditional Chinese and Western medicine for the treatment of urinary tract infections before enrollment after the onset of this disease for more than 3 days; (6) Merge severe cardiovascular system, liver (ALT, AST, TBIL exceeding 1.5 times the upper limit of normal range), kidney (Cr, BUN exceeding 1.5 times the upper limit of normal range), respiratory and hematopoietic system diseases, malignant tumors or mental disorders; (7) Type I diabetes or type II diabetes with poor blood glucose control (glycosylated hemoglobin>8.5%); (8) Antibiotics should not be used to treat allergic reactions to antibiotics or allergic reactions to experimental drug components; (9) Pregnant and lactating women, or those who plan to conceive and are unwilling to use effective contraceptive measures; (10) Suspected or confirmed history of alcohol and drug abuse; (11) Participated in drug clinical trials within 3 months prior to enrollment; According to the researcher's judgment, there are other influencing factors that are not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical recurrence rate / average recurrence frequency during the whole study period (treatment period + follow-up period);Urine bacteriology positive recurrence rate / average recurrence frequency during the whole study period (treatment period + follow-up period);Clinical recurrence rate / average recurrence frequency during the follow-up period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical recurrence rate / average recurrence frequency during treatment;Recurrence rate of positive urine bacteriology during treatment / average recurrence frequency;Recurrence rate of positive urine bacteriology / average recurrence frequency during the follow-up period;Recurrence time of first urinary tract infection;Time of first urinary tract infection recurrence after clinical response;Clinical response, microbial response and comprehensive efficacy of acute lower urinary tract infection;Disappearance time of clinical symptoms of acute infection;Days of antibiotic use during treatment;Changes from baseline in total score of TCM syndromes and single symptom score;Evaluation of TCM syndrome curative effect; | — |
Countries
China
Contacts
Public ContactYongli Zhan
Guang'anmen Hospital, Chinese Academy of Traditional Chinese Medicine
Outcome results
None listed