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Efficacy and Safety of Acupuncture for Functional Constipation

This study is currently recruiting participants.
Verified May 2013 by Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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: May 5, 2013
Last verified: May 2013
History of Changes
  Purpose

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. .


Condition Intervention Phase
Constipation
 Other: acupuncture
Drug: mosapride citrate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Acupuncture for Functional Constipation: a Multi-center Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:

Primary Outcome Measures:
  • change from baseline in unaided complete self-defecation frequencies 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 complete defecation of one week without the help of medicines or hands


Secondary Outcome Measures:
  • 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 complete self-defecation frequency of a week at the 8th week [ Time Frame: at the 8th week ] [ Designated as safety issue: No ]
    frequencies of complete 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


Estimated Enrollment: 700
Study Start Date: September 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture at ST25 and BL25
the points formula of back-shu point combination with front-mu point.
 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
Experimental: Acupuncture at LI11 and ST37
the points formula of He-points
 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
Experimental: Acupuncture at ST25, BL25, LI11 and ST37
the formula of He-point,back-shu point and front-mu point
 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
Active Comparator: medicine
oral use of mosapride citrate
 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

Detailed Description:

functional constipation,acupuncture,effects and safety,pragmatic RCT

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411501

Contacts
Contact: LIU Zhishun, phD 8610-010-88001124 liuzhishun@aliyun.com

Locations
China
No.5 Beixiange Street, Xuanwu District Recruiting
Beijing, China, 100053
Contact: LIU Zhishun, phD     8610-010-88001124     liuzhishun@aliyun.com    
Principal Investigator: LIU Zhishun, phD            
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Ministry of Science and Technology of the People´s Republic of China
Investigators
Study Chair: LIU Zhishun, phD Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences
  More Information

No publications provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Liu Zhishun, Dean of Acupuncture Department of Guangan'men Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01411501     History of Changes
Other Study ID Numbers: 2011CB505202
Study First Received: July 28, 2011
Last Updated: May 5, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
Acupuncture
Functional constipation

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Citric Acid
Mosapride
Anticoagulants
Hematologic Agents
Therapeutic Uses
 Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 22, 2013