Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

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.

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

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

3
Prenumerera