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| Name | Class |
|---|---|
| Xiyuan Hospital of China Academy of Chinese Medical Sciences | OTHER |
| Shanghai University of Traditional Chinese Medicine | OTHER |
| Guangdong Provincial Hospital of Traditional Chinese Medicine | OTHER |
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The purpose of this study is to evaluate the efficacy, safety and immune mechanism of Sanjin tablets for the treatment of acute simple lower urinary tract infection and its influence on recurrence rate.
In order to evaluating the efficacy, safety and immune mechanism of Sanjin tablets for the treatment of acute simple lower urinary tract infection and its influence on recurrence rate and through research data to guide clinical, improving the rational use of drugs, especially the rational application of antibiotics. In this study, a randomized, double blind, parallel control of positive drugs, multi-center clinical study will be established. According to the relevant regulations of the CFDA, 252 cases need to be registered at least. These cases will be divided into treatment group(Sanjin tablets+ levofloxacin simulants),control group 1(Sanjin tablets simulants +levofloxacin)and control group 2(Sanjin tablets+ levofloxacin). Each group will be treated for 7 days and followed up for 2 times. The efficacy indicators of this study were mainly from three dimensions: syndrome, laboratory routine examination and bacteriology examination. The symptom scores and cytokine changes of each group before and after treatment were observed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sanjin tablets group | Experimental | Sanjin tablets+ levofloxacin simulants |
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| Levofloxacin group | Placebo Comparator | Sanjin tablets simulants +levofloxacin |
|
| Sanjin tablets+ Levofloxacin group | Active Comparator | Sanjin tablets+ levofloxacin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sanjin tablets | Drug | Sanjin tablets,3 pills /time, 4 times/ day, for 7 days+levofloxacin simulants,0.1g, po bid, for 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The lower urinary tract infection symptoms of 252 participants will be assessed | The symptoms mainly includes frequent urination,urgent urination,urinary pain, lower abdominal pain and pain in the kidney area.If these symptoms disappear after 7 days of medication,it indicates the subject is cured. | After 7 days of medication |
| Measure | Description | Time Frame |
|---|---|---|
| The urine leukocyte of 252 participants will be assessed | If the urine leukocyte return to normal value after 7 days of medication,it indicates the subject is cured. | After 7 days of medication |
| The bacteriological examination of 252 participants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanming Xie, BA | Contact | 86-13911112416 | ktzu2018@163.com | |
| Lianxin Wang, Doctor | Contact | 86-13521781839 | wlxing@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yanming Xie, BA | Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31324199 | Derived | Lyu J, Xie YM, Gao Z, Shen JW, Deng YY, Xiang ST, Gao WX, Zeng WT, Zhang CH, Yi DH, Wang LX, Wang ZF. Sanjin tablets for acute uncomplicated lower urinary tract infection (syndrome of dampness-heat in the lower jiao): protocol for randomized, double-blind, double-dummy, parallel control of positive drug, multicenter clinical trial. Trials. 2019 Jul 19;20(1):446. doi: 10.1186/s13063-019-3539-5. |
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| ID | Term |
|---|---|
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
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| Hubei Hospital of Traditional Chinese Medicine | OTHER |
| Chengdu University of Traditional Chinese Medicine | OTHER |
| Yunnan Provinical Hospital of Traditional Chinese Medicine | OTHER |
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| Sanjin tablets simulants | Drug | levofloxacin ,0.1g, po bid, for 7 days+Sanjin tablets simulants,3 pills /time, 4 times/ day, for 7 days. |
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| Levofloxacin | Drug | Sanjin tablets,3 pills /time, 4 times/ day, for 7 days+levofloxacin,0.1g, po bid, for 7 days. |
|
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If the original infected part of the specimen did not regenerate the original infected pathogen after 7 days of medication,it indicates the subject is cured.
| After 7 days of medication |
| The recurrence rate of subjects who is cured in 252 participants will be assessed by lower urinary tract infection symptoms | If the lower urinary tract infection symptoms of subjects who is cured appears again in the fourth week after end of medication,it indicates the subject has relapsed. | 28 days after the end of treatment |
| The recurrence rate of subjects who is cured in 252 participants will be assessed by urine leukocyte | If the urine leukocyte value of subjects who is cured rises again in the fourth week after end of medication,it indicates the subject has relapsed. | 28 days after the end of treatment |
| The recurrence rate of subjects who is cured in 252 participants will be assessed by bacteriological examination | If the urine culture of subjects who is cured indicates that the original urinary tract pathogen is positive again in the fourth week after end of medication,it indicates the subject has relapsed. | 28 days after the end of treatment |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |