Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00219505
Status:
TERMINATED
Last Update Posted:
2017-11-24
First Post:
2005-09-14
Brief Title:
Effect of Acupuncture on Symptoms of Diarrhea and Pain in IBS
Sponsor:
Penn State University
Organization:
Penn State University
Study Overview
Official Title:
Effect of Acupuncture on Symptoms of Diarrhea and Pain in Diarrhea Predominant Irritable Bowel Syndrome IBS and Effect on Plasma Beta-endorphin and Serotonin Levels
Status:
TERMINATED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no eligible subjects identified during recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acupuncture has been used for centuries in China in the treatment of diarrhea Our hypothesis is that acupuncture is effective in the treatment of abdominal pain and diarrhea in patients with diarrhea-predominant IBS
Detailed Description:
Patients will complete a diary to determine if they qualify for the study Patients will be randomized to receive either acupuncture or sham acupuncture needle insertion 1 cm away from acupuncture site Patients will be blinded to whether they are receiving acupuncture or sham acupuncture The acupuncturist is blinded as to the patient response The patients will undergo venupuncture to draw blood to determine sertotonin and beta-endorphin levels They will receive treatment in 12 sessions over 4 weeks They will maintain a diary during this time period to document level of pain and frequency of bowel movements Blood will be drawn at week 2 and 4 and 6 weeks after cessation of treatment subjects will again record abdominal symptoms and frequency of bowel movements for 2 weeks Blood will be drawn for hormone levels at 8 weeks after completion of study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None