Efficacy and Safety of Acupuncture for Functional Constipation

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

acupuncture

mosapride citrate

About this trial

This is an interventional treatment trial for Constipation focused on measuring Acupuncture, Functional constipation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients who has been diagnosed with functional constipation according to Rome Ⅲ criteria
Patients who are aged 18-75 years old
Stop medication or acupuncture (if any) 1 week before randomization and uninvolved in other trials
Sign the informed consent out of one's own will

Exclusion Criteria:

Secondary constipation
Patients with consciousness impairment, psychotic patients or patients unable to express clearly
Patients with malignant tumor in progressive stage, severe wasting disease and liable to be infected and bleed
Patients with severe cardiovascular disease, hepatic injury, renal damage, digestive disease or hematological diseases
Women in pregnancy and lactation period

Sites / Locations

No.5 Beixiange Street, Xuanwu District

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Acupuncture at ST25 and BL25

Acupuncture at LI11 and ST37

Acupuncture at ST25, BL25, LI11 and ST37

medicine

Arm Description

the points formula of back-shu point combination with front-mu point.

the points formula of He-points

the formula of He-point,back-shu point and front-mu point

oral use of mosapride citrate

Outcomes

Primary Outcome Measures

Change of the SBMs From Baseline at Week 4

[average number of spontaneous bowel movements in a week at week 4]-[average number of spontaneous bowel movements in a week at baseline]

Secondary Outcome Measures

Change From Baseline in the Bristol Stool Scale at the 4th Week

Bristol stool scale provides illustration of seven stool types. It ranges from 1 to 7 with the meaning that 1 referring to separate hard lumps and 7 referring to watery, no solid pieces. For patients with constipation, a higher score means a better outcome. This outcome means the Bristol Stool Scale at the 4th week-the Bristol Stool Scale at baseline.

Change From Baseline in Difficulty Degree of Defecation at the 4th Week

This outcome describes how much effort the patients with while defecating.It ranges from 0 to 3. 0-Without difficulty Defecation straining Severe defecation straining Defecation with the help of hands, A 0 is considered better than 3 for outcome. Patients score for themselves according to their own feelings. [the average score of one week at the 4th week]-[the average score of one week at baseline]

Changes of the SBMs From Baseline at Week 8

[average number of spontaneous bowel movements in a week at week 8]-[average number of spontaneous bowel movements in a week at baseline]

Change From Baseline in the Bristol Stool Scale at the 8th Week

Bristol stool scale provides illustration of seven stool types. It ranges from 1 to 7 with the meaning that 1 referring to separate hard lumps and 7 referring to watery, no solid pieces. For patients with constipation, a higher score means a better outcome. This outcome means the Bristol Stool Scale at the 8th week-the Bristol Stool Scale at baseline.

Change From Baseline in Difficulty Degree of Defecation at the 8th Week

This outcome describes how much effort the patients with while defecating. It ranges from 0 to 3. 0-Without difficulty Defecation straining Severe defecation straining Defecation with the help of hands, A 0 is considered better than 3 for outcome. Patients score for themselves according to their own feelings. [the average score of one week at the 8th week]-[the average score of one week at baseline]

Full Information

NCT ID

NCT01411501

First Posted

July 28, 2011

Last Updated

November 8, 2015

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Collaborators

Ministry of Science and Technology of the People´s Republic of China

1. Study Identification

Unique Protocol Identification Number

NCT01411501

Brief Title

Efficacy and Safety of Acupuncture for Functional Constipation

Official Title

Efficacy and Safety of Acupuncture for Functional Constipation: a Multi-center Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Collaborators

Ministry of Science and Technology of the People´s Republic of China

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A multi-center clinical trial done recently by us(NCT00508482) shows that needling on ST25 has the same effect as lactulose in unaided self-defecation frequency of a week and has better effect in symptoms improvement (in press). The object is to evaluate whether acupuncture is effective for functional constipation. As an explanatory research, it took one single point as its intervention and sham acupuncture as its control group (patients were blinded). On the basis of its confirmed effect, we are taking a pragmatic randomized controlled trial to further evaluate whether acupuncture is more effective than routine treatment. Acupuncture prescriptions used in this trial are individually prescribed according to syndrome differentiation, which can improve clinical effect. .

Detailed Description

functional constipation,acupuncture,effects and safety,pragmatic RCT

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation

Keywords

Acupuncture, Functional constipation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

684 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture at ST25 and BL25

Arm Type

Experimental

Arm Description

the points formula of back-shu point combination with front-mu point.

Arm Title

Acupuncture at LI11 and ST37

Arm Type

Experimental

Arm Description

the points formula of He-points

Arm Title

Acupuncture at ST25, BL25, LI11 and ST37

Arm Type

Experimental

Arm Description

the formula of He-point,back-shu point and front-mu point

Arm Title

medicine

Arm Type

Active Comparator

Arm Description

oral use of mosapride citrate

Intervention Type

Other

Intervention Name(s)

acupuncture

Other Intervention Name(s)

acupuncture and moxibustion

Intervention Description

Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA). Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used. Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks.

Intervention Type

Drug

Intervention Name(s)

mosapride citrate

Other Intervention Name(s)

mosapride citrate,made in China

Intervention Description

4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal

Primary Outcome Measure Information:

Title

Change of the SBMs From Baseline at Week 4

Description

[average number of spontaneous bowel movements in a week at week 4]-[average number of spontaneous bowel movements in a week at baseline]

Time Frame

baseline and at 4 weeks

Secondary Outcome Measure Information:

Title

Change From Baseline in the Bristol Stool Scale at the 4th Week

Description

Bristol stool scale provides illustration of seven stool types. It ranges from 1 to 7 with the meaning that 1 referring to separate hard lumps and 7 referring to watery, no solid pieces. For patients with constipation, a higher score means a better outcome. This outcome means the Bristol Stool Scale at the 4th week-the Bristol Stool Scale at baseline.

Time Frame

baseline and at 4 weeks

Title

Change From Baseline in Difficulty Degree of Defecation at the 4th Week

Description

This outcome describes how much effort the patients with while defecating.It ranges from 0 to 3. 0-Without difficulty Defecation straining Severe defecation straining Defecation with the help of hands, A 0 is considered better than 3 for outcome. Patients score for themselves according to their own feelings. [the average score of one week at the 4th week]-[the average score of one week at baseline]

Time Frame

baseline and at 4 weeks

Title

Changes of the SBMs From Baseline at Week 8

Description

[average number of spontaneous bowel movements in a week at week 8]-[average number of spontaneous bowel movements in a week at baseline]

Time Frame

baseline and at 8 weeks

Title

Change From Baseline in the Bristol Stool Scale at the 8th Week

Description

Bristol stool scale provides illustration of seven stool types. It ranges from 1 to 7 with the meaning that 1 referring to separate hard lumps and 7 referring to watery, no solid pieces. For patients with constipation, a higher score means a better outcome. This outcome means the Bristol Stool Scale at the 8th week-the Bristol Stool Scale at baseline.

Time Frame

baseline and at 8 weeks

Title

Change From Baseline in Difficulty Degree of Defecation at the 8th Week

Description

This outcome describes how much effort the patients with while defecating. It ranges from 0 to 3. 0-Without difficulty Defecation straining Severe defecation straining Defecation with the help of hands, A 0 is considered better than 3 for outcome. Patients score for themselves according to their own feelings. [the average score of one week at the 8th week]-[the average score of one week at baseline]

Time Frame

baseline and at 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Patients who has been diagnosed with functional constipation according to Rome Ⅲ criteria Patients who are aged 18-75 years old Stop medication or acupuncture (if any) 1 week before randomization and uninvolved in other trials Sign the informed consent out of one's own will Exclusion Criteria: Secondary constipation Patients with consciousness impairment, psychotic patients or patients unable to express clearly Patients with malignant tumor in progressive stage, severe wasting disease and liable to be infected and bleed Patients with severe cardiovascular disease, hepatic injury, renal damage, digestive disease or hematological diseases Women in pregnancy and lactation period

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

LIU Zhishun, phD

Organizational Affiliation

Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences

Official's Role

Study Chair

Facility Information:

Facility Name

No.5 Beixiange Street, Xuanwu District

City

Beijing

ZIP/Postal Code

100053

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

22759406

Citation

Li Y, Zheng H, Zeng F, Zhou SY, Zhong F, Zheng HB, Chen M, Jing XH, Cai YY, Jia BH, Zhu B, Liu ZS. Use acupuncture to treat functional constipation: study protocol for a randomized controlled trial. Trials. 2012 Jul 3;13:104. doi: 10.1186/1745-6215-13-104.

Results Reference

derived

Constipation

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial