Urinary Tract Infection Lower AcutePhase 4NCT03658291
Clinical Study of Sanjin Tablets for the Treatment of Acute Simple Lower Urinary Tract Infection
A Phase 4 study testing Sanjin tablets, Sanjin tablets simulants and Levofloxacin in people with Urinary Tract Infection Lower Acute, run by China Academy of Chinese Medical Sciences.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Urinary Tract Infection Lower Acute
- What is being tested?
- Sanjin tablets, Sanjin tablets simulants and Levofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 31 Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects aged 18 to 50 years of age.
- Meets the western diagnostic criteria of acute simple lower urinary tract infection, the disease duration does not exceed 72 hours.
- Urine retention in the screening period -1-0 days, bacterial culture results were sensitive to levofloxacin.(Urine retention for bacterial culture and clinical treatment at the same time)
- The syndrome differentiation of TCM is syndrome of dampness-heat in lower jiao.
- Did not receive antibiotic treatment within 48 hours Before being selected.
- The inclusion of those who confirmed not pregnant
- Those who agree to participate in this clinical trial and sign the informed consent, the process of informed consent meet the relevant provisions of the GCP.
Who cannot join
- Those who are allergic to the test drug ingredients or quinolones.
- In the past, there was a history of bacterial culture that was not sensitive to levofloxacin.
- Diagnosed as complicated urinary tract infection.
- Patients with urinary calculi or obstruction, urinary tuberculosis, renal papillary necrosis, perinephric abscess or neurogenic bladder.
- Combined with vaginitis symptoms, genital ulcers or gonorrhea.
- Combined with severe cardiopulmonary disease, liver and kidney disease, advanced tumor, blood, central nervous system (such as the history of epilepsy) or other serious or progressive disease.
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- A patient who has a neurological or mental illness and cannot cooperate.
- Infected persons who must use other antibacterial drugs in combination.
- Pregnancy, lactating women or recent birth planners.
- Those who have participated in other clinical trials within 3 months before being selected.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Sanjin Tablets for the Treatment of Acute Simple Lower Urinary Tract Infection and Its Influence on Recurrence Rate: a Randomized, Double Blind, Parallel Control of Positive Drugs, Multi-center Clinical Study
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.
Read the detailed description
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.
- Conditions
- Urinary Tract Infection Lower Acute
- Being tested
- Sanjin tablets, Sanjin tablets simulants, Levofloxacin
- Keywords
- Sanjin tablets, efficacy and safety, recurrence rate, randomized, double blind, parallel control, multi-center clinical study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sanjin tabletsDrug
Also called levofloxacin simulants
Sanjin tablets,3 pills /time, 4 times/ day, for 7 days+levofloxacin simulants,0.1g, po bid, for 7 days.
Sanjin tablets simulantsDrug
Also called Levofloxacin
levofloxacin ,0.1g, po bid, for 7 days+Sanjin tablets simulants,3 pills /time, 4 times/ day, for 7 days.
LevofloxacinDrug
Also called Sanjin tablets
Sanjin tablets,3 pills /time, 4 times/ day, for 7 days+levofloxacin,0.1g, po bid, for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Sanjin tablets group | Experimental | Sanjin tablets+ levofloxacin simulants Receives: Drug: Sanjin tablets |
| Levofloxacin group | Placebo comparator | Sanjin tablets simulants +levofloxacin Receives: Drug: Sanjin tablets simulants |
| Sanjin tablets+ Levofloxacin group | Active comparator | Sanjin tablets+ levofloxacin Receives: Drug: Levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 7 days of medication
Secondary outcomes (5)
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.
Measured: After 7 days of medication
The bacteriological examination of 252 participants
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 28 days after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start1 Jan 2019 (estimated)
- Primary completion30 Jun 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract Infection Lower AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Xiyuan Hospital of China Academy of Chinese Medical Sciences, Longhua Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Hubei Hospital of Traditional Chinese Medicine, Chengdu University of Traditional Chinese Medicine, Yunnan Provinical Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Yanming Xie, China Academy of Chinese Medical Sciences
- Investigators
- Yanming Xie, BA, Principal investigator, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658291
- Sponsor's protocol ID
- Sanjin tablets
- Status last verified
- Nov 2018
- First submitted
- 24 Jul 2018
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31324199
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sanjin Tablets for the Treatment of Acute Simple Lower Urinary Tract Infection and Its Influence on Recurrence Rate: a Randomized, Double Blind, Parallel Control of Positive Drugs, Multi-center Clinical Study
- ClinicalTrials.gov ID
- NCT03658291
- Acronym / sponsor ID
- Sanjin tablets
- Conditions
- Urinary Tract Infection Lower Acute
- Keywords
- Sanjin tablets, efficacy and safety, recurrence rate, randomized, double blind, parallel control, multi-center clinical study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Xiyuan Hospital of China Academy of Chinese Medical Sciences, Longhua Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Hubei Hospital of Traditional Chinese Medicine, Chengdu University of Traditional Chinese Medicine, Yunnan Provinical Hospital of Traditional Chinese Medicine
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 5 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sanjin tablets group | Experimental | Drug: Sanjin tabletsSanjin tablets+ levofloxacin simulants |
| Levofloxacin group | Placebo comparator | Drug: Sanjin tablets simulantsSanjin tablets simulants +levofloxacin |
| Sanjin tablets+ Levofloxacin group | Active comparator | Drug: LevofloxacinSanjin tablets+ levofloxacin |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects aged 18 to 50 years of age.
- Meets the western diagnostic criteria of acute simple lower urinary tract infection, the disease duration does not exceed 72 hours.
- Urine retention in the screening period -1-0 days, bacterial culture results were sensitive to levofloxacin.(Urine retention for bacterial culture and clinical treatment at the same time)
- The syndrome differentiation of TCM is syndrome of dampness-heat in lower jiao.
- Did not receive antibiotic treatment within 48 hours Before being selected.
Key exclusion criteria (10 listed)
- Those who are allergic to the test drug ingredients or quinolones.
- In the past, there was a history of bacterial culture that was not sensitive to levofloxacin.
- Diagnosed as complicated urinary tract infection.
- Patients with urinary calculi or obstruction, urinary tuberculosis, renal papillary necrosis, perinephric abscess or neurogenic bladder.
- Combined with vaginitis symptoms, genital ulcers or gonorrhea.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sanjin tabletsAlso: levofloxacin simulantsSanjin tablets,3 pills /time, 4 times/ day, for 7 days+levofloxacin simulants,0.1g, po bid, for 7 days. | Drug | Sanjin tablets group |
| Sanjin tablets simulantsAlso: Levofloxacinlevofloxacin ,0.1g, po bid, for 7 days+Sanjin tablets simulants,3 pills /time, 4 times/ day, for 7 days. | Drug | Levofloxacin group |
| LevofloxacinAlso: Sanjin tabletsSanjin tablets,3 pills /time, 4 times/ day, for 7 days+levofloxacin,0.1g, po bid, for 7 days. | Drug | Sanjin tablets+ Levofloxacin group |
Primary outcome
The lower urinary tract infection symptoms of 252 participants will be assessed
Time frame: After 7 days of medication
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.
5 secondary outcomes
The urine leukocyte of 252 participants will be assessed
Time frame: After 7 days of medication
The bacteriological examination of 252 participants
Time frame: 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
Time frame: 28 days after the end of treatment
The recurrence rate of subjects who is cured in 252 participants will be assessed by urine leukocyte
Time frame: 28 days after the end of treatment
The recurrence rate of subjects who is cured in 252 participants will be assessed by bacteriological examination
Time frame: 28 days after the end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
- Derived from this study: PubMed 31324199Lyu 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanming Xie, BA principal investigator
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sanjin tablets, Sanjin tablets simulants and Levofloxacin in people with Urinary Tract Infection Lower Acute, run by China Academy of Chinese Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanming Xie, BA (86-13911112416, ktzu2018@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The lower urinary tract infection symptoms of 252 participants will be assessed (time frame: After 7 days of medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03658291, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2018.