Clinical randomized controlled trial of acupuncture for functional constipation based on the theory of “interior-exterior relationship between the lung and the large Intestine”

Registration number:

ITMCTR2024000312

Date of Last Refreshed on:

2024-08-27

Date of Registration:

2024-08-27

Registration Status:

Retrospective registration

Public title:

Clinical randomized controlled trial of acupuncture for functional constipation based on the theory of “interior-exterior relationship between the lung and the large Intestine”

English Acronym:

Scientific title:

Clinical randomized controlled trial of acupuncture for functional constipation based on the theory of “interior-exterior relationship between the lung and the large Intestine”

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

Applicant:

YanXE

Study leader:

TanC

Applicant telephone:

18801040063

Study leader's telephone:

13488782477

Applicant Fax:

Study leader's fax:

Applicant E-mail:

unnyyan@163.com

Study leader's E-mail:

tancheng206@126.com

Study leader's website(voluntary supply):

https://www.dzmyy.com.cn/

Study leader's website
(voluntary supply):

Applicant address:

No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing100029

Study leader's address:

Dongcheng District, Hai Yun Cang on the 5th Zip

Applicant postcode:

100029

Study leader's postcode:

100700

Applicant's institution:

Dongzhimen Hospital of BeijingUniversity of Chinese Medicine

Approved by ethic committee:

Approved No. of ethic committee:

2024DZMEC-187-02

Approved file of Ethical Committee:

View

Name of the ethic committee:

Medical Ethics Committee of Dongzhimen Hospital of BeijingUniversity of Chinese Medicine

Date of approved by ethic committee:

2024/6/18 0:00:00

Contact Name of the ethic committee:

HanXT

Contact Address of the ethic committee:

Ethics Office, Dongzhimen Hospital, Beijing University of Chinese Medicine, Room H108

Contact phone of the ethic committee:

84012709

Contact email of the ethic committee:

dzmyyec@126.com

Primary sponsor:

Dongzhimen Hospital of BeijingUniversity of Chinese Medicine

Primary sponsor's address:

Dongcheng District, Hai Yun Cang on the 5th Zip

Secondary sponsor:

Country:

China

Province:

Beijing

City:

Dongcheng District

Institution
hospital:

Dongzhimen Hospital of BeijingUniversity of Chinese Medicine

Address:

Dongcheng District, Hai Yun Cang on the 5th Zip

Source(s) of funding:

Funding for Postgraduate Projects at Dongzhimen Hospital of Beijing University of Chinese Medicine

Target disease:

Functional constipation

Target disease code:

Study type:

Interventional study

Study design:

randomized controlled trial(parallel group design)

Study phase:

Pilot clinical trial

Objectives of Study:

In this study we used a randomised controlled trial to verify the efficacy of acupuncture in treating functional constipation based on the theory of 'interior-exterior relationship between the lung and the large Intestine in order to provide a new idea for the treatment of chronic functional constipation by acupuncture. The aim of this study is to provide new ideas for the treatment of chronic functional constipation with acupuncture.

Description for medicine or protocol of treatment in detail:

A randomised (random number table method) single-blind (blinding the subjects) controlled design was used to randomly divide the subjects into 2 groups: 36 cases in the control group (acupoints: ST25 ST37 SJ6 and KI6 leave the needle in place for 20 minutes after Deqi) and 36 cases in the experimental group (acupoints: ST25 ST37 SJ6 and KI6 LU5 and LU7 leave the needle in place for 20 minutes after Deqi.). The probability of random assignment to the two groups was 50% each. Both groups received a 4-week acupuncture treatment three times a week. The use of 110ml of glycerol or 40-60ml of sorbitol anal enema as rescue medication was allowed during the treatment period and recorded in the Wexner scale for constipation.

Inclusion criteria

1.Patients meeting the Rome IV diagnostic criteria for functional constipation; 2. 18 years old ≤ age ≤ 75 years old, gender is not limited; 3. Subjects had not taken constipation medication [other than emergency medications (including glycerin or sorbitol anal enemas) for at least 2 weeks prior to group entry] had not been treated with constipation acupuncture in the last 2 months and had not been enrolled in any other trial in the last 3 months; 4. subjects met the criteria for severe FC in the Chinese Expert Consensus Opinion on Chronic Constipation (2019); 5. Subjects are personally informed of the contents of this study and are willing to cooperate and sign the informed consent form

Exclusion criteria:

1. Serious cardiovascular, hepatic or renal disease 2. Cognitive dysfunction, aphasia, psychiatric disorders, or conditions that may affect the patient's cooperation; and 3. Pregnant or lactating women. 4. Patients with coagulation disorders such as abdominal aortic aneurysm, hepatosplenomegaly, or routine use of anticoagulants, including warfarin or heparin (except for antiplatelet therapy with aspirin or clopidogrel); 5. Patients who do not tolerate needling such as pacemaker implants.

Study execute time:

From 2024-06-19

To      2025-06-18

Recruiting time:

From 2024-06-19

To      2025-05-18

Interventions:

36

Group:

Control group (routine acupoint taking group)

Sample size:

Intervention:

Acupuncture points were taken bilaterally from S ST25 ST37 SJ6 and KI6, with no tonic or diarrhoeal manoeuvres implemented after each point was pricked to obtain qi, and the needles were left in place for 20 minutes. The use of 110 ml of glycerol or 40- 60 ml of sorbitol anal enema was allowed as rescue medication during the treatment period and was recorded in the Constipation Wexner Scale.

Intervention code:

36

Group:

Test group (lung meridian point group)

Sample size:

Intervention:

Acupuncture points were taken bilaterally from ST25 ST37 SJ6 and KI6 LU5 and LU7, with no tonic or diarrhoeal manoeuvres implemented after each point was pricked to obtain qi, and the needles were left in place for 20 minutes. The use of 110 ml of glycerol or 40- 60 ml of sorbitol anal enema was allowed as rescue medication during the treatment period and was recorded in the Constipation Wexner Scale.

Intervention code:

Total sample size : 72

Countries of recruitment
and research settings:

Country:

China

Province:

Beijing

City:

Dongcheng District

Institution/hospital:

Dongzhimen Hospital of Beijing University of Chinese Medicine

Level of the institution:

Level 3A hospital

Outcomes:

Outcome:

Wexner Continence Grading Scale

Type:

Secondary indicator

Measure time point of outcome:

baseline, after the 1st, 2nd, 3rd, 4th week of treatment and 2 weeks after the end of treatment

Measure method:

Subjects completed the scale, selecting situations up to 1 week to complete.

Outcome:

Complete Spontaneous Bowel Movements, (CSBMs)

Type:

Primary indicator

Measure time point of outcome:

baseline, after the 1st, 2nd, 3rd, 4th week of treatment and 2 weeks after the end of treatment

Measure method:

Subjects recorded the number of bowel movements per week during the study period without the need for laxatives or maneuvers, with a spontaneous sense of complete evacuation.

Outcome:

Bristol Stool Scale

Type:

Primary indicator

Measure time point of outcome:

baseline, after the 1st, 2nd, 3rd, 4th week of treatment and 2 weeks after the end of treatment

Measure method:

Subjects recorded each bowel movement trait and chose the option with the highest number of occurrences at each evaluation. The Bristol Stool Trait Score categorizes stools into types I-VII, with each category rated on a scale of 1-7, with higher stool trait scores suggesting less constipation in patients.

Outcome:

Patient-Assessment of Constipation Quality Of Life (PAC-QOL)

Type:

Secondary indicator

Measure time point of outcome:

baseline, after the 1st, 2nd, 3rd, 4th week of treatment and 2 weeks after the end of treatment

Measure method:

Subjects completed the scale, selecting situations up to 1 week to complete.

Collecting sample(s)
from participants:

Sample Name:

This study did not involve the collection of human specimens.

Tissue:

Fate of sample 

Others

Note:

Recruiting

18
Min age years
75
Max age years

Recruiting status:

Participant age:

Gender:

Both

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

A third researcher that without operating acupuncture used the random number table method to generate random number columns.

Blinding:

In this study the subjects were hidden from the group and the subjects were not able to see the acupoints of the other subjects; the assessors were hidden from the group.

IPD sharing:

No

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

-

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

Raw information was captured using a Case Record Form (CRF) and data was managed using the ResMan Electronic Data Capture and Management System (EDC).

Data Managemen Committee:

Not yet

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

Public release of findings in the form of a paper is expected by August 2025, journal not yet determined.

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