Constipation Clinical Trial
Official title:
A Clinical Standardization Study of the Preferred Acupuncture Treatment Protocol to Treat Functional Constipation
The purpose of this study is to re-evaluate the therapeutic superiority and safety of acupuncture treatment using high quality and large sampled clinical research. The investigators want to provide a preferred treatment protocol, which is effective, safe, and easy to use in clinical practice. This research also clarifies that the insertion depth is a key factor in the therapeutic effect of acupuncture. The results of the study will help promote the development of the standardization of acupuncture.
Status | Completed |
Enrollment | 475 |
Est. completion date | November 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - meeting the diagnosis of Rome III criteria; - aged from 18 to 75 years old; - no use of medicine for constipation about 2 weeks before the enrollment, no acupuncture treatment for constipation in the previous 3 months, and never joined any other trial in progress in the previous 3 months; - volunteered to join this trial and signed the informed consent form Exclusion Criteria: - irritable bowel syndrome, organic constipation or secondary constipation caused by endocrine, metabolic, nervous, postoperative diseases, or by drugs; - constipation with serious cardiovascular, hepatic or renal diseases, cognitive dysfunction, aphasia, mental disorders, or illness which affects the cooperation for examination and treatment; - women in gestation or lactation period; - abdominal aortic aneurysm or hepatosplenomegaly, etc.; - blood coagulation disorders or using anticoagulants regularly such as Warfarin and Heparin; - cardiac pacemaker carrier. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences | Beijing | 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 Mean Weekly Spontaneous Bowel Movements | Spontaneous bowel movements per week were assessed every week during 4 weeks of treatment according to patients' diaries. Weekly spontaneous bowel movements were also assessed at the 4th and 12th week of follow-up according to patients' diaries. | over 4-week treatment, at the 4th week of follow-up, at the 12th week of follow-up | No |
Secondary | Change of Mean Value of Straining During Defecating | Score of straining during defecating was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of straining during defecating over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. We corrected the mean value of straining during defecating by covariance because the data had significant difference among three groups at baseline. | over 4 weeks of treatment | No |
Secondary | Change of Mean Value of Incomplete Evacuation | Score of incomplete evacuation was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of incomplete evacuation over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. | over 4 weeks of treatment | No |
Secondary | Change of Mean Value of Stool Consistency | Score of stool consistency was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of stool consistency over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. We corrected the mean value of stool consistency by covariance because the data had significant difference among three groups at baseline. | over 4 weeks of treatment | No |
Secondary | Change of Mean Value of Abdominal Distention | Score of abdominal distention was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of abdominal distention over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. We corrected the mean value of abdominal distention by covariance because the data had significant difference among three groups at baseline. | over 4 weeks of treatment | No |
Secondary | Change of Mean Value of Cleveland Clinic Score | Cleveland Clinic Score was assessed by doctors which contains eight items about constipation-related symptoms. Score ranges from '0' to '30'. '0' means none of symptoms and '30' means very severe symptoms. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. | over 4 weeks of treatment | No |
Secondary | Time to the First Spontaneous Bowel Movement After the First Treatment | counting by hours | No | |
Secondary | Percentage of the Usage of Emergency Drugs | over 4 weeks of treatment | No | |
Secondary | Percentage of the Usage of Emergency Drugs | at the 4th week of follow-up | No | |
Secondary | Percentage of the Usage of Emergency Drugs | at the 12th week of follow-up | No |
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