Efficacy and Safety of Acupuncture for Functional Constipation

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01411501
• Other study ID #: 2011CB505202
• Status: Completed
• Phase: Phase 3
• First received: July 28, 2011
• Last updated: November 8, 2015
• Start date: September 2011
• Est. completion date: December 2014

Study information

• Verified date: November 2015
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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. .

Description:

functional constipation,acupuncture,effects and safety,pragmatic RCT

Recruitment information / eligibility

• Status: Completed
• Enrollment: 684
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients who has been diagnosed with functional constipation according to Rome ? 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

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 (f0.30×25mm,f0.30×40mm,f0.30×50mm, 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.

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

Locations

Country	Name	City	State
China	No.5 Beixiange Street, Xuanwu District	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences	Ministry of Science and Technology of the People´s Republic of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]	baseline and at 4 weeks	Yes
Secondary	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.	baseline and at 4 weeks	Yes
Secondary	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]	baseline and at 4 weeks	No
Secondary	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]	baseline and at 8 weeks	No
Secondary	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.	baseline and at 8 weeks	No
Secondary	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]	baseline and at 8 weeks	No