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Efficacy and Safety of Acupuncture for Functional Constipation

This study has been completed.
Sponsor:
Collaborator:
Ministry of Science and Technology of the People´s Republic of China
Information provided by (Responsible Party):
Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01411501
First received: July 28, 2011
Last updated: November 8, 2015
Last verified: November 2015

July 28, 2011
November 8, 2015
September 2011
October 2014   (final data collection date for primary outcome measure)
Change of the SBMs From Baseline at Week 4 [ Time Frame: baseline and at 4 weeks ] [ Designated as safety issue: Yes ]
[average number of spontaneous bowel movements in a week at week 4]-[average number of spontaneous bowel movements in a week at baseline]
change from baseline in unaided self-defecation frequency of a week at the 4th week [ Time Frame: at the 4th week ] [ Designated as safety issue: Yes ]
based on patient's diary,assess frequencies of defecation of one week without the help of medicines or hands
Complete list of historical versions of study NCT01411501 on ClinicalTrials.gov Archive Site
  • Change From Baseline in the Bristol Stool Scale at the 4th Week [ Time Frame: baseline and at 4 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: baseline and at 4 weeks ] [ Designated as safety issue: No ]

    This outcome describes how much effort the patients with while defecating.It ranges from 0 to 3.

    0—Without difficulty

    1. Defecation straining
    2. Severe defecation straining
    3. 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 [ Time Frame: baseline and at 8 weeks ] [ Designated as safety issue: No ]
    [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 [ Time Frame: baseline and at 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and at 8 weeks ] [ Designated as safety issue: No ]

    This outcome describes how much effort the patients with while defecating. It ranges from 0 to 3.

    0—Without difficulty

    1. Defecation straining
    2. Severe defecation straining
    3. 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]

  • Change From Baseline in the Bristol Stool Scale at the 4th Week [ Time Frame: at the 4th week ] [ Designated as safety issue: Yes ]
    type 1-7 corresponds to score 1-7, assess the average score of one week in the 4th week
  • Change From Baseline in Difficulty Degree of Defecation at the 4th Week [ Time Frame: at the 4th week ] [ Designated as safety issue: No ]

    0—Without difficulty

    1. Defecation straining
    2. Severe defecation straining
    3. Defecation with the help of hands, assess the average score of one week in the 4th week
  • change from baseline in SF-36 at the 4th week [ Time Frame: at the 4th week ] [ Designated as safety issue: No ]
    the MOS item Short From health survey
  • change from baseline in SDS at the 4th week [ Time Frame: at the 4th week ] [ Designated as safety issue: No ]
    Self-rating Depression Scale
  • change from baseline in unaided self-defecation frequency of a week at the 8th week [ Time Frame: at the 8th week ] [ Designated as safety issue: No ]
    frequencies of defecation of one week without the help of medication or hands
  • Change From Baseline in the Bristol Stool Scale at the 8th Week [ Time Frame: at the 8th week ] [ Designated as safety issue: No ]
    type 1-7 corresponds to score 1-7,assess the average score of one week in the 8th week
  • Change From Baseline in Difficulty Degree of Defecation at the 8th Week [ Time Frame: at the 8th week ] [ Designated as safety issue: No ]

    0—Without difficulty

    1. Defecation straining
    2. Severe defecation straining
    3. Defecation with the help of hands, assess the average score of one week in the 8th week
  • change from baseline in SAS at the 4th week [ Time Frame: at the 4th week ] [ Designated as safety issue: No ]
    Self-Rating Anxiety Scale
Not Provided
Not Provided
 
Efficacy and Safety of Acupuncture for Functional Constipation
Efficacy and Safety of Acupuncture for Functional Constipation: a Multi-center Randomized Controlled Trial
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. .
functional constipation,acupuncture,effects and safety,pragmatic RCT
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Constipation
  • Other: 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.

    Other Name: acupuncture and moxibustion
  • Drug: mosapride citrate
    4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal
    Other Name: mosapride citrate,made in China
  • Experimental: Acupuncture at ST25 and BL25
    the points formula of back-shu point combination with front-mu point.
    Intervention: Other: acupuncture
  • Experimental: Acupuncture at LI11 and ST37
    the points formula of He-points
    Intervention: Other: acupuncture
  • Experimental: Acupuncture at ST25, BL25, LI11 and ST37
    the formula of He-point,back-shu point and front-mu point
    Intervention: Other: acupuncture
  • Active Comparator: medicine
    oral use of mosapride citrate
    Intervention: Drug: mosapride citrate
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
684
December 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01411501
2011CB505202
Yes
Not Provided
Not Provided
Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Ministry of Science and Technology of the People´s Republic of China
Study Chair: LIU Zhishun, phD Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP