Based on the effect of intestinal microecology on mitochondrial energy supply, this study explored the efficacy of Jiawei Qilang prescription in the treatment of drug-dependent constipation

Registration number:

ITMCTR2200005525

Date of Last Refreshed on:

2022-01-11

Date of Registration:

2022-01-11

Registration Status:

Prospective registration

Public title:

Based on the effect of intestinal microecology on mitochondrial energy supply, this study explored the efficacy of Jiawei Qilang prescription in the treatment of drug-dependent constipation

English Acronym:

Scientific title:

Clinical evaluation of modified Qilang prescription in the treatment of drug-dependent constipation by improving intestinal microecology

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

ChiCTR2200055507 ; ChiMCTR2200005525

Applicant:

Zhang Kehui

Study leader:

Li Yong

Applicant telephone:

19921842930

Study leader's telephone:

021-56639828

Applicant Fax:

Study leader's fax:

Applicant E-mail:

285593405@qq.com

Study leader's E-mail:

liyong_SCI@126.com

Study leader's website(voluntary supply):

Study leader's website
(voluntary supply):

Applicant address:

No.274, Zhijiang Middle Road, Jing 'an District, Shanghai

Study leader's address:

274 Middle Zhijiang Road

Applicant postcode:

200071

Study leader's postcode:

200071

Applicant's institution:

Shanghai Municipal Hospital of Traditional Chinese Medicine

Approved by ethic committee:

Approved No. of ethic committee:

2018SHL-KYYS-22

Approved file of Ethical Committee:

View

Name of the ethic committee:

Shanghai Municipal Hospital of Traditional Chinese Medicine Ethics Committee

Date of approved by ethic committee:

2018/5/30 0:00:00

Contact Name of the ethic committee:

Contact Address of the ethic committee:

Contact phone of the ethic committee:

Contact email of the ethic committee:

Primary sponsor:

Shanghai Municipal Hospital of Traditional Chinese Medicine

Primary sponsor's address:

No.274, Zhijiang Middle Road, Jing 'an District, Shanghai

Secondary sponsor:

Country:

China

Province:

Shanghai

City:

上海市

Institution
hospital:

Shanghai Municipal Hospital of Traditional Chinese Medicine

Address:

No.274, Zhijiang Middle Road, Jing 'an District, Shanghai

Source(s) of funding:

Science and Technology Commission of Shanghai Municipality

Target disease:

Constipation

Target disease code:

Study type:

Interventional study

Study design:

randomized controlled trial(parallel group design)

Study phase:

Others

Objectives of Study:

The main results are as follows: 1) through a randomized double-blind double-simulation controlled study, the effectiveness and safety of Jiawei Qilang prescription were confirmed in clinic. To explore the objectivity and advantages of modified Qilang prescription in the treatment of drug-dependent constipation in traditional Chinese medicine, and to lay a foundation for further research on the application of modified Qilang prescription in drug-dependent constipation and prepare for patent conversion. 2) the intestinal microecological characteristics of patients with drug-dependent constipation and healthy people before and after treatment were analyzed and compared, and the changes of intestinal microecology of patients with drug-dependent constipation were evaluated. to explore the regulatory effect of Jiawei Qilang recipe on intestinal microflora in patients with drug-dependent constipation.

Description for medicine or protocol of treatment in detail:

Inclusion criteria

The TCM diagnostic criteria of Qi-Yin deficiency syndrome (refer to the consensus of TCM experts in diagnosis and treatment of constipation of spleen and stomach Disease Branch of Chinese Society of traditional Chinese Medicine (2017)) the main symptoms are as follows: reduced defecation frequency, prolonged defecation cycle, or difficult fecal quality, difficulty in defecation, or weakness in defecation. Secondary symptoms: Qi deficiency: 1) fatigue and lazy speech; 2) stupefaction; 3) abdominal distension and yin deficiency: 1) hand and foot heart heat; 2) body weight loss; 3) worry and lack of sleep. In line with at least 2 main symptoms, 2 secondary syndromes, qi deficiency and yin deficiency, each disease symptom grading and quantification combined with the guiding principles and related principles of clinical research of new drugs of traditional Chinese medicine. 2.2 Western diagnostic criteria: (1) constipation: the diagnostic criteria are established with reference to the Rome IV diagnostic criteria, as follows: at least 12 weeks in the past 6 months (not necessarily continuous) the following two or more things have occurred: strenuous defecation of more than 11pm; dry knot or hardness of defecation above 21mm4 (refer to Bristol stool trait 1 or 2); and incomplete defecation in defecation of more than 31mm4. 3There is a sense of anorectal obstruction or obstruction when defecation above 41p4, extra help (finger picking, pelvic floor massage) is needed when defecation is above 41x4, spontaneous defecation is less than 3 times a week, and there is no loose defecation, and it is not enough to diagnose irritable bowel syndrome. (2) the history of discontinuation or continuous use of laxatives containing anthraquinones in one year was more than 6 months, and the course of disease was more than 1 year. (3) others: organic diseases were excluded by relevant examination. 2.3 the inclusion criteria meet the diagnostic criteria of western medicine for drug-dependent constipation; the syndrome differentiation of traditional Chinese medicine is deficiency of both qi and yin; the age is from 18 to 70 years old (including 18 and 70 years old); voluntarily participate in this experiment and agree to sign informed consent.

Exclusion criteria:

Complicated with organic diseases such as digestive tract, cardiovascular, cerebrovascular, liver, kidney, hematopoietic system and other serious primary diseases; patients with a history of mental illness or mental illness; patients less than 18 years old or more than 70 years old; patients who could not tolerate drug treatment in this study; pregnant and lactating women; any situation considered unsuitable for selection in the study

Study execute time:

From 2021-01-01

To      2022-01-01

Recruiting time:

From 2021-01-01

To      2022-01-01

Interventions:

80

Group:

treatment group

Sample size:

Intervention:

jiawei qilang power+Duphalacsimulation agent treatment

Intervention code:

80

Group:

control group

Sample size:

Intervention:

jiawei qilang simulation power+Duphalac

Intervention code:

Total sample size : 160

Countries of recruitment
and research settings:

Outcomes:

Outcome:

High-throughput 16SrDNA sequencing and analysis of feces

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

5-hydroxytryptamine

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Collecting sample(s)
from participants:

Sample Name:

Feces

Tissue:

Fate of sample 

Destruction after use

Note:

Sample Name:

Serum

Tissue:

Fate of sample 

Destruction after use

Note:

Recruiting

Min age years
Max age years

Recruiting status:

Participant age:

Gender:

Both

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

The drugs were randomly assigned and blinded by the statisticians of Shanghai University of traditional Chinese Medicine who did not participate in the clinical trial. SPSS21.0 statistical software was used to sow random seeds to generate random numbers. Two subjects in the same pair were randomly assigned to&#

Blinding:

Double-blind design includes primary blindness and secondary blindness. The drugs were randomly assigned and blinded by the statisticians of Shanghai University of traditional Chinese Medicine who did not participate in the clinical trial. SPSS21.0 statistical software was used to sow random seeds to generate random numbers. Two subjects in the same pair were randomly assigned to group An and group B according to the size of random numbers. Two sets of drug numbers An and B were produced at the same time. Patients in group A took medicine An and patients in group B took medicine B. The actual number of blind cases was 160, which were divided into two groups: treatment group (n = 80) and control group (n = 80). The blindness process was carried out according to the code of operation of clinical trial drug coding in the affiliated Hospital of Shanghai University of traditional Chinese Medicine, and the blindness process was recorded in detail. At the same time, a number was written on each subject's medicine box and an emergency letter was prepared for each case. The envelope is marked with the patient's matching number and drug code, and the sealed letter paper in the envelope indicates the group to which the patient belongs and the specific type and dose of drugs taken by the patient in that group, which can be used in case of emergency blindness detection.

IPD sharing:

Yes

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

Private

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

Case Record Form

Data Managemen Committee:

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

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above