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Cohort study on efficacy and safety of Xiaoshi tablets in the treatment of urinary calculi

Registration number：

ITMCTR2024000619

Date of Last Refreshed on：

2024-10-29

Date of Registration：

2024-10-29

Registration Status：

Prospective registration

Public title：

Cohort study on efficacy and safety of Xiaoshi tablets in the treatment of urinary calculi

English Acronym：

Scientific title：

Cohort study on efficacy and safety of Xiaoshi tablets in the treatment of urinary calculi

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

ZHOU Mengyuan

Study leader：

LI Jing

Applicant telephone：

17760214200

Study leader's telephone：

13671131943

Applicant Fax：

Study leader's fax：

Applicant E-mail：

doer15649858759@163.com

Study leader's E-mail：

natashalee@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Dongzhimen Hospital Beijing University of Chinese Medicine

Study leader's address：

Dongzhimen Hospital Beijing University of Chinese Medicine

Applicant postcode：

100700

Study leader's postcode：

100700

Applicant's institution：

Dongzhimen Hospital, Beijing University of Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2024DZMEC-445-02

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Dongzhimen Hospital Beijing University of Chinese Medicine

Date of approved by ethic committee：

2024/10/14 0:00:00

Contact Name of the ethic committee：

HAN Xueting

Contact Address of the ethic committee：

Dongzhimen Hospital Beijing University of Chinese Medicine

Contact phone of the ethic committee：

18101127292

Contact email of the ethic committee：

dzmyyec@126.com

Primary sponsor：

Conson Pharmaceutical Group

Primary sponsor's address：

No.5 Ocean Warehouse, Dongcheng District, Beijing

Secondary sponsor：

Country：

China

Province：

Beijing

City：

北京

Institution
hospital：

Dongzhimen Hospital, Beijing University of Chinese Medicine

Address：

No.5 Ocean Warehouse, Dongcheng District, Beijing

Source(s) of funding：

The experimental drug and its funding are funded by Kangson Pharmaceutical Group

Target disease：

Urinary calculus

Target disease code：

Study type：

Observational study

Study design：

Cohort study

Study phase：

Others

Objectives of Study：

1. To verify the effectiveness of Xiaoshi tablets in the treatment of urinary calculi, the main indexes are clinical efficacy and syndrome efficacy; 2. To verify the safety of Xiaoshi tablets in the treatment of urinary stones.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

① Meet the relevant diagnostic criteria of urinary calculi; ② The imaging examination confirmed the diagnosis of urinary calculi and the diameter of calculi was ≤6mm; ③ In line with the indications of drug stone removal; Age 18-70 years old, gender is not limited; ⑤ Voluntarily sign informed consent, with a certain degree of compliance.

Exclusion criteria：

① Complicated with cerebral infarction, coronary heart disease, pulmonary edema, liver cirrhosis, tumor and various mental diseases; ② has been diagnosed with urinary system anatomical abnormalities (such as pyeloureteral junction stenosis); (3) CT indicates that the renal pelvis or ureter is obviously dilated and effusion; ④ Recently participated in other drug researchers; (5) Prepare women during pregnancy, lactation and pregnancy; ⑥ Patients who were judged by the investigator to be unable to join the study.

Study execute time：

From 2024-10-01

To      2026-12-31

Recruiting time：

From 2024-12-01

To      2026-10-30

Interventions：

166

Group：

Non-exposed group

Sample size：

Intervention：

none

Intervention code：

166

Group：

Exposed group

Sample size：

Intervention：

Take Xiaoshi tablets

Intervention code：

Total sample size ： 332

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

----

Institution/hospital：

Dongzhimen Hospital, Beijing University of Chinese Medicine

Level of the institution：

Class III, Class A hospital

Outcomes：

Outcome：

TCM syndrome scale

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

VAS

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Stone removal rate

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Patient evaluation questionnaire

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Clinical effective rate

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Recurrence rate

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
70
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

none

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

2027-09-01 CNKI https://www.cnki.net/

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data were collected in case report form, Excel was used for electronic data collection, and SPSS software was used for statistical analysis

Data Managemen Committee：

Not yet

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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