- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05524675
The Effect of Multiple Medications on the Incidence of Organic Dyspepsia
30. august 2022 opdateret af: Yanglin Pan, Air Force Military Medical University, China
The Effect of Multiple Medications on the Incidence of Organic Dyspepsia:a Prospective Observational Cohort
Dyspepsia is a very common gastrointestinal disease, presented as predominant symptom of upper abdominal pain.
Underlying causes for dyspepsia can classified as organic or functional dyspepsia.
Some medications (eg.
non-steroid anti-inflammatory drugs (NSAIDs)) were associated with higher frequent incidences of organic lesions.
Multiple medications showed an increased trend with aging of the population and multimorbidity.
Multiple medications were suggested to be strongly relate to adverse drug events (ADEs), adverse drug reactions (ADRs), drug-drug interactions, and drug-disease interactions, which had been reported to lead to higher incidences of some diseases, including fractures, cognitive impairment and malnutrition.
However, it was unknown if multiple medications was associated with more incidences of organic dyspepsia.
Studieoversigt
Status
Rekruttering
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Forventet)
500
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Yanglin Pan
- Telefonnummer: 13991811225
- E-mail: yanglinpan@hotmail.com
Studiesteder
-
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Gansu
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Lanzhou, Gansu, Kina
- Ikke rekrutterer endnu
- Lanzhou University Second Hospital
-
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Shaanxi
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Xi'an, Shaanxi, Kina, 710032
- Rekruttering
- Xijing Hospital of Digestive Diseases
-
Kontakt:
- Yanglin Pan
- Telefonnummer: 13991811225
- E-mail: yanglinpan@hotmail.com
-
Xi'an, Shaanxi, Kina, 710032
- Ikke rekrutterer endnu
- The Second Affiliated Hospital of Xi'an Jiaotong University
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Xi'an, Shaanxi, Kina, 710032
- Ikke rekrutterer endnu
- Xijing 986 Hospital
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Patients aged ≥ 18 years old who met broad criteria of dyspepsia with upper endoscopy and abdominal ultrasonography within one year were eligible for our study.
Beskrivelse
Inclusion Criteria:
- aged ≥18 years old
- patients who met broad criteria of dyspepsia
- undergoing upper endoscopy and abdominal ultrasonography within one year.
Exclusion Criteria:
- organ failure defined by Marshall standard
- severe psychiatric illnesses
- suspected or identified bowel obstruction
- known malignancy
- pregnancy or lactation
- unable to provide consent
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
the rate of patients diagnosed with organic upper gastrointestinal (GI) diseases.
Tidsramme: 1 day
|
All included patients underwent upper GI endoscopy and abdominal ultrasound and H. Pylori test.
Barrett's esophagus, esophageal candidiasis, esophageal cancer, gastric ulcer, gastric erosion, gastric cancer, duodenal ulcer, duodenal erosion, cholecystitis, pancreatitis and biliary stones were classified as organic upper GI diseases.
|
1 day
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Short Form of Nepean Dyspepsia Index (SF-NDI)
Tidsramme: 1 dag
|
SF-NDI består af 10 spørgsmål vedrørende virkningerne af dyspepsisymptomer ("maveproblemer") på forskellige aspekter af livet (spændinger, forstyrrelse af daglige aktiviteter, spisning/drikning, viden/kontrol og arbejde/studie).
Hvert svar kan være fra 1 (slet ikke påvirket) til 5 (ekstremt påvirket) eller 0 (ikke relevant), for en samlet summeret score ud af 50.
|
1 dag
|
Functional dyspepsia
Tidsramme: 6 months
|
Functional dyspepsia was defined by Rome IV criteria, which was based on symptom and duration rather than scores.
Patients diagnosed as Rome IV criteria met one or more of following criteria: postprandial fullness, early satiation, epigastric pain, and epigastric burning that are unexplained after a routine clinical evaluation, Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.
the above symptoms and durations were included in the questionaire.
Physiological parameter was not required for Rome IV criteria.
|
6 months
|
Number of participants with different subtypes of functional dyspepsia
Tidsramme: 6 months
|
Functional dyspepsia was based on Rome IV criteria, which was based on symptom and duration rather than scores.
Functional dyspepsia was classified into three subgroups:(1) Postprandial Distress Syndrome, Must include one or both of the following at least 3 days per week: 1. Bothersome postprandial fullness (ie, severe enough to impact on usual activities) 2. Bothersome early satiation (ie, severe enough to prevent finishing a regular-size meal) (2) Bothersome epigastric pain, Must include at least 1 of the following symptoms at least 1 day a week: 1. Bothersome epigastric pain (ie, severe enough to impact on usual activities) AND/OR 2. Bothersome epigastric burning (ie, severe enough to impact on usual activities).
(3) mixed syndrome, defined when postprandial distress syndrome and epigastric pain syndrome presented simultaneously
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6 months
|
Hospital anxiety scale
Tidsramme: 1 day
|
Anxiety of patients are assessed by using Hospital Anxiety Scale.It contains 7 items, which assess symptoms experienced during the past week on a 0-3 scale.
A subscore of > 8 for anxiety would indicate a clinical case.
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1 day
|
Hospital depression scale
Tidsramme: 1 day
|
Depression of patients are assessed by using Hospital Depression Scale.
It contains 7 items, which assess symptoms experienced during the past week on a 0-3 scale.
A score of > 8 for depression would indicate a clinical case.
|
1 day
|
Quality of Life scores
Tidsramme: 1 day
|
Quality of Life scores assessed by Patient-reported outcomes measurement information system (PROMIS) Global-10 questionnaire.PROMIS Global-10 is a newly validated 10-question survey used to assess health care-related quality of life measures for the general population.
It's a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales.
These scores are then standardized to the general population, using the "T-Score".
The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points.
Higher scores indicate a healthier patient and a better quality of life.
|
1 day
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Severity of functional dyspepsia judged by patients
Tidsramme: 1 day
|
Patients rated the severity of functional dyspepsia as mild, moderate, and severe by themselves.
|
1 day
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Number of participants with other functional gastrointestinal diseases
Tidsramme: 1 day
|
Other functional gastrointestinal diseases#such as irritable bowel syndrome(IBS) or functional heartburn#etc.
|
1 day
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juni 2022
Primær færdiggørelse (Forventet)
31. december 2023
Studieafslutning (Forventet)
1. juni 2024
Datoer for studieregistrering
Først indsendt
20. august 2022
Først indsendt, der opfyldte QC-kriterier
30. august 2022
Først opslået (Faktiske)
1. september 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. september 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. august 2022
Sidst verificeret
1. august 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KY20222180-F-2
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