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Study of the effect of acupuncture on treatment of acute radiation enteritis in pelvic tumor radiotherapy

Registration number：

ITMCTR2200005764

Date of Last Refreshed on：

2022-03-26

Date of Registration：

2022-03-26

Registration Status：

Prospective registration

Public title：

Study of the effect of acupuncture on treatment of acute radiation enteritis in pelvic tumor radiotherapy

English Acronym：

Scientific title：

Study of the effect of acupuncture on treatment of acute radiation enteritis in pelvic tumor radiotherapy

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2200057999 ; ChiMCTR2200005764

Applicant：

Wangjiao

Study leader：

Wangjiao

Applicant telephone：

15222339010

Study leader's telephone：

15222339010

Applicant Fax：

Study leader's fax：

Applicant E-mail：

15222339010@163.com

Study leader's E-mail：

15222339010@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

82 Xinhua South Road, Tongzhou District, Beijing

Study leader's address：

82 Xinhua South Road, Tongzhou District, Beijing

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Beijing Luhe Hospital Capital Medical University

Approved by ethic committee：

Approved No. of ethic committee：

2021-LHKY-103-03

Approved file of Ethical Committee：

Name of the ethic committee：

Medical ethics committee of Beijing Luhe Hospital Affiliated to Capital Medical University

Date of approved by ethic committee：

1990/1/1 0:00:00

Contact Name of the ethic committee：

Lihaiyan

Contact Address of the ethic committee：

82 Xinhua South Road, Tongzhou District, Beijing

Contact phone of the ethic committee：

010-60569362

Contact email of the ethic committee：

Primary sponsor：

Beijing Luhe Hospital Capital Medical University

Primary sponsor's address：

82 Xinhua South Road, Tongzhou District, Beijing

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Institution
hospital：

Beijing Luhe Hospital Capital Medical University

Address：

82 Xinhua South Road, Tongzhou District, Beijing

Source(s) of funding：

Self financing

Target disease：

Acute radiation enteritis

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

Guided by the basic theory of traditional Chinese medicine and based on the principle of dialectical treatment, this project designs a randomized controlled clinical study to explore the clinical efficacy of acupuncture in the prevention and treatment of acute radiation enteritis in pelvic tumors, and explore a more long-term and convenient green therapy for acute radiation enteritis.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

① Age 20 ~ 70 years old; ② Meet the diagnostic criteria of acute radiation enteritis; ③ No major organ dysfunction, no previous history of major gastrointestinal diseases; ④ The estimated survival time is more than 3 months; ⑤ KPS score is greater than 70; ⑥ No history of antibiotic use within two weeks; ⑦ Willing to cooperate and sign informed consent.

Exclusion criteria：

The existence of any of the following items is excluded: ① those with a history of gastrointestinal diseases such as Crohn's disease and ulcerative colitis; ② Pregnant and lactating women; ③ Patients in urgent need of operation such as intestinal obstruction and perforation; ④ Have serious cardiovascular, cerebrovascular, lung, liver, kidney and other basic diseases; ⑤ Hypersensitivity to sulfonamides; ⑥ Severe coagulation dysfunction; ⑦ Patients with enterostomy; ⑧ Severe allergy to metals.

Study execute time：

From 2021-09-01

To      2022-08-31

Recruiting time：

From 2022-03-22

To      2022-10-01

Interventions：

26

Group：

Control group

Sample size：

Intervention：

Nil

Intervention code：

26

Group：

Treatment group

Sample size：

Intervention：

acupuncture

Intervention code：

Total sample size ： 52

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Institution/hospital：

Beijing Luhe Hospital Capital Medical University

Level of the institution：

Tertiary hospital

Outcomes：

Outcome：

CRP

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Whole blood cell analysis

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Detection of intestinal flora

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Grading of intestinal injury

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

TNF-α

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

biochemical examination

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

TCM syndrome score

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

IL-6

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Whole blood cell analysis

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Assessment of efficacy

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Faeces

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

Min age years
Max age years

Recruiting status：

Participant age：

Gender：

Male

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

Statistical professionals from the third party who did not participate in the study used SPSS 23.0 software to generate random number table and random sequence.

Blinding：

IPD sharing：

Yes

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

Paper publication

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

The cases were screened by case screening form (CSF), and the data during the trial were recorded by case report form (CRF). Case screeners and recorders are trained and fixed personnel to ensure the homogeneity of data records. All data shall be applied with epidata3 1. For management, the data is entered by two persons independently, and the accuracy of the entered data is guaranteed after verification and correction.

Data Managemen Committee：

Yes

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

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