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Completed

NCT Number: NCT01411501

Efficacy and Safety of Acupuncture for Functional Constipation

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. .

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

No.5 Beixiange Street, Xuanwu District

Beijing, 100053, China

About this study

functional constipation,acupuncture,effects and safety,pragmatic RCT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

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.

Other names: acupuncture and moxibustion

Mosapride citrate

Drug

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

Other names: mosapride citrate,made in China

Primary outcomes

  1. Change of the SBMs From Baseline at Week 4

    Time frame: baseline and at 4 weeks

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

Secondary outcomes

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

    Time frame: baseline and at 4 weeks

    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.

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

    Time frame: baseline and at 4 weeks

    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]

  3. Changes of the SBMs From Baseline at Week 8

    Time frame: baseline and at 8 weeks

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

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

    Time frame: baseline and at 8 weeks

    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.

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

    Time frame: baseline and at 8 weeks

    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]

Sponsors and collaborators

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 8, 2011
Registry last updated
Dec 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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