- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00624793
Acupuncture for Nausea in HIV (AcuN)
21 juni 2012 uppdaterad av: NYU Langone Health
Acupuncture for Chronic Nausea in HIV: A Randomized Clinical Trial
The subjects in this research study will be 159 men and women with HIV infection who have a history of chronic nausea for three months or greater and show evidence of two or more episodes of nausea and/or report a duration of two hours or more (per day) in baseline symptom diaries.
Subjects will be randomized (by chance) to one of three conditions: Condition 1, subjects receive Standard acupuncture (active treatment); Condition 2, subjects receive Individualized acupuncture based on Traditional Chinese Medical Diagnosis (active treatment); Condition 3, (Control Group), subjects receive Sham acupuncture.
Subjects in Conditions 1, 2, & 3 will attend scheduled sessions over 24 weeks.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The subjects in the proposed experiment will be 159 men and women with HIV infection who have a history of chronic nausea for three months or greater and show evidence of two or more episodes of nausea and/or report a duration of 2 hours or greater (per day) in prospective baseline symptom diaries.
Subjects will be randomized to one of three experimental intervention conditions: Condition 1, subjects receive Standard acupuncture; Condition 2, subjects receive Individualized acupuncture based on Traditional Chinese Medical Diagnosis; Condition 3, (Control Group), subjects receive Sham acupuncture.
Subjects in Conditions 1, 2, & 3 will attend 16 scheduled sessions over 24 weeks.
All subjects will: be assessed by a diagnostic acupuncturist (blinded to treatment assignments); be administered the same instruments; and submit their symptom diaries for data entry and analysis.
After a screening/intake session, randomization and treatment sessions will follow.
There will be four weeks of twice weekly treatment sessions, four weekly treatment sessions and three follow-up sessions.
All conditions will be identical in duration and be administered by licensed acupuncturists trained in Traditional Chinese Medicine.
This study is a prospective, randomized, controlled, blinded (subject and evaluator), parallel groups clinical trial aimed at reducing chronic nausea and improving quality of life in persons with HIV/AIDS.
Studietyp
Interventionell
Inskrivning (Faktisk)
159
Fas
- Fas 2
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Men and women HIV positive or CDC AIDS diagnosed
- History of chronic nausea for three months or greater
- Experience an average of two or more episodes of nausea and/or who experience an average duration of 2 hours or more (of nausea) per day
- Verification from Primary provider of subject's: HIV status, knowledge of patient's nausea and their agreement that their patient is clinically suitable for the study.
- Individuals able to successfully complete a mini-mental status exam
- Individuals who understand and agree to complete daily symptom diaries for the duration of the study.
- Individuals taking antiretroviral combinations must have completed an initial 8 weeks of a stable regime (same drug(s), dose & frequency) prior to entry into the study.
- Individuals taking anti-emetic medications must be on a stable regime (same drug, dose & frequency) for at least fourteen days prior to entry into the study.
- Individuals on all other medications which may have nausea listed as a side effect must be on a stable regime (same drug(s), dose & frequency) for at least fourteen (14) days prior to entry in the study
Exclusion Criteria:
- Individuals with an acute medical condition, i.e. pneumocystis carinii pneumonia, tuberculosis and or other opportunistic infections or conditions that would require medical attention.
- Pregnant women
- Individuals receiving acupuncture currently and less than 6 months prior to enrollment.
- Individuals currently receiving other types of complementary therapies such as herbs, massage, acupressure wrist bands, reiki etc.
- Individuals with plans for travel, lifestyle change, or other activity that would preclude attending all of the planned study sessions and/or recording daily diary information.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: I. Standard
Standard - Formula Acup Protocol
|
Standard Acup point protocol for treating nausea
|
Experimentell: 2. Individualized
Individualized Acup protocol based on TCM diagnosis
|
Acup
|
Sham Comparator: 3
(Control Group) Sham acupuncture
|
Sham Acup - Non-Active
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
INVR - symptom diary Clinical Global Impression Scales
Tidsram: Baseline, treatment and follow-ups sessions
|
Baseline, treatment and follow-ups sessions
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
QOL scale MOS-SF-36 subscales
Tidsram: Baseline, treatment and follow-up session
|
Baseline, treatment and follow-up session
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2005
Primärt slutförande (Faktisk)
1 november 2011
Avslutad studie (Faktisk)
1 december 2011
Studieregistreringsdatum
Först inskickad
19 februari 2008
Först inskickad som uppfyllde QC-kriterierna
19 februari 2008
Första postat (Uppskatta)
27 februari 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
22 juni 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 juni 2012
Senast verifierad
1 juni 2012
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 09-0339
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på HIV-infektioner
-
Institut PasteurRekrytering
-
Duke UniversityAvslutadCentral Line-associated Bloodstream Infection (CLABSI)Förenta staterna
-
Catholic University of the Sacred HeartAvslutadCentral Line-associated Bloodstream Infection (CLABSI)
-
The University of Texas Health Science Center,...EurofinsAvslutadOdontogen Deep Space Neck InfectionFörenta staterna
-
Princess Maxima Center for Pediatric OncologyUMC Utrecht; Dutch Cancer SocietyRekryteringCentral Line-associated Bloodstream Infection (CLABSI)Nederländerna
-
University of MalayaTeleflexRekryteringCLABSI - Central Line Associated Bloodstream InfectionMalaysia
-
Johns Hopkins UniversityAvslutadCLABSI - Central Line Associated Bloodstream InfectionFörenta staterna
-
National Taiwan University Hospital Hsin-Chu BranchAvslutadCentral Line-associated Bloodstream Infection (CLABSI)
-
National Taiwan University HospitalAvslutadCentral Line-associated Bloodstream Infection (CLABSI)Taiwan
-
University of ZurichHar inte rekryterat ännuCentral Line-associated Bloodstream Infection (CLABSI) | Kateterrelaterad blodomloppsinfektion