Constipation Clinical Trial
Official title:
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. .
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | No.5 Beixiange Street, Xuanwu District | Beijing |
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 |
China,
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 |
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