Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010491
Status:
COMPLETED
Last Update Posted:
2008-03-07
First Post:
2001-02-02
Brief Title:
Acupuncture and Moxa A Randomized Clinical Trial for Chronic Diarrhea in HIV Patients
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Acupuncture and Moxa A Randomized Clinical Trial for Chronic Diarrhea in HIV Patients
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to test alternative treatment strategies to reduce the frequency of chronic diarrhea among HIV positive individuals 60 percent of patients with HIV disease in the US will have diarrhea at some point in their illness Although in general many of the opportunistic infections OIs associated with HIV have decreased due to new drug cocktails many of these drugs however have diarrhea as a side effect In Asian countries acupuncture including moxibustion has been widely used for the treatment of various gastrointestinal GI disorders However there are no published studies that test treatment protocols using acupuncture or moxibustion on patients with HIV experiencing chronic diarrhea
Detailed Description:
The subjects in the study will be 144 men and women with HIV infection who report experiencing 3 or more episodes of diarrhea non-pathogen related per 24 hour period for 3 weeks or more Subjects will be randomized to one of four experimental intervention conditions Condition 1 subjects receive true acupuncture and true moxibustion Condition 2 subjects receive true acupuncture and placebo moxibustion Condition 3 subjects receive true moxibustion and sham acupuncture Condition 4 Control Group subjects receive sham acupuncture and placebo moxibustion Subjects in Conditions 123 4 will attend 20 scheduled sessions over 24 weeks Week 1 is a baseline session followed by two sessions per week for weeks 2-8 sessions 2-15 one session per week for weeks 9 10 11 and 12 sessions 16 17 18 19 and a final follow-up session at week 24 All subjects will complete daily bowel movement and medication data collection diaries for the duration of the study Measurement of quality of life and level of functioning will be taken pre-intervention session 1 week 6 session 10 week 12 session 19 and week 24 session 20 All interventions will be implemented by licensed acupuncturists trained in traditional Chinese medicine This study is designed to assess the efficacy of two alternative medicine treatments for chronic diarrhea associated with HIV in a prospective randomized controlled blinded parallel groups study under the intent-to-treat principle True acupuncture moxibustion and combination therapy in which specific meridian points are stimulated according to protocol will be compared to each other and with the control group with one-way ANOVA models for pre-treatment minus post-treatment difference scores for diarrhea frequency and stool consistency as the dependent measures and treatment group assignment Conditions 1 - 4 as the independent variable Average pretreatment diarrhea frequency and stool consistency scores will be entered as covariates into these models Sample size determination for the above analysis based on preliminary data with 80 power and a two-tailed type I error rate of 05 by the method of Holm 1979 and a 20 attrition factor indicates the need for 36 subjects assigned to each condition to detect a 095-standardized difference between the most extreme experimental conditions
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AT000146-02 | NIH | None | httpsreporternihgovquickSearchR01AT000146-02 |
| R01AT000146-01 | NIH | None | None |