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Efficacy and Safety of Acupuncture for Functional Constipation

NCT ID: NCT01411501

Last Updated: 2015-12-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

684 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-12-31

Brief Summary

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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

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functional constipation,acupuncture,effects and safety,pragmatic RCT

Conditions

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Constipation

Keywords

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Acupuncture Functional constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Acupuncture at ST25 and BL25

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

Group Type EXPERIMENTAL

acupuncture

Intervention Type OTHER

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.

Acupuncture at LI11 and ST37

the points formula of He-points

Group Type EXPERIMENTAL

acupuncture

Intervention Type OTHER

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.

Acupuncture at ST25, BL25, LI11 and ST37

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

Group Type EXPERIMENTAL

acupuncture

Intervention Type OTHER

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.

medicine

oral use of mosapride citrate

Group Type ACTIVE_COMPARATOR

mosapride citrate

Intervention Type DRUG

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

Interventions

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acupuncture

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 OTHER

mosapride citrate

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

Intervention Type DRUG

Other Intervention Names

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acupuncture and moxibustion mosapride citrate,made in China

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER_GOV

Sponsor Role collaborator

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Liu Zhishun

Dean of Acupuncture Department of Guangan'men Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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LIU Zhishun, phD

Role: STUDY_CHAIR

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

Locations

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No.5 Beixiange Street, Xuanwu District

Beijing, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 22759406 (View on PubMed)

Other Identifiers

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2011CB505202

Identifier Type: -

Identifier Source: org_study_id