- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02822118
Therapeutic Effect of Chang'an I Recipe on Irritable Bowel Syndrome With Diarrhea
2. september 2016 opdateret af: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Therapeutic Effect of Chang'an I Recipe on Irritable Bowel Syndrome With Diarrhea: A Multicenter Randomized Double-Blind Placebo-Controlled Clinical Trial
To evaluate the efficacy and safety of TCM decoction Chang'an I Recipe in the treatment of IBS-D.
A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed.
Patients were applied for central random number and were given corresponding treatment according to inclusion sequences.The treatment group was administered the Chang'an I Recipe, 150ml/bag, 3 times/day; while the control group was administered the placebo, 150ml/bag, 3 times/day.
Both courses of treatment were 8 weeks.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
216
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Beijing
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Beijing, Beijing, Kina, 100700
- Dongzhimen Hospital
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Beijing, Beijing, Kina, 100091
- Xiyuan Hospital
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Beijing, Beijing, Kina, 100102
- Wangjing Hospital
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Shanghai
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Shanghai, Shanghai, Kina, 200032
- Longhua Hospital
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310006
- Zhejiang Provincial Hospital of TCM
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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 til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients meeting the diagnostic criteria of Western medicine for IBS-D;
- aged 18-70 years old; with a baseline IBS-SSS score over 75 points;
- voluntarily signed the informed consent;
- local resident who could ensure follow-ups, with basic reading ability.
Exclusion Criteria:
- Patients with IBS-C, -M, and uncertain forms;
- accompanied with serious lesions in major organs including heart, liver, and kidney, hematopoietic system diseases, and tumors;
- gastrointestinal organic disease (e.g., chronic pancreatitis), or systemic diseases affecting the digestive tract motion (e.g., hyperthyroidism, diabetes, chronic renal insufficiency, and nervous system diseases);
- undergoing or requiring constant use of drugs that may affect gastrointestinal functions (e.g., anti-cholinergic drugs, calcium channel blockers, 5-HT3 receptor antagonist, antidiarrheal agents, antacids, prokinetic agents, antidepressants, anxiolytics, and intestinal flora regulating drugs);
- with history of abdominal surgery (e.g., cholecystectomy);
- with an allergy history of tested drugs or severe allergy history of food;
- pregnant and lactating female;
- with a history of neurological or psychiatric disorders;
- or participating in other clinical trial.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Chang'an I Recipe
Patients in this group were administered the Chang'an I Recipe for 8 weeks.
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Patients in this group were administered the Chang'an I Recipe, 150ml/bag, 3 times/day for 8 weeks.
Andre navne:
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Placebo komparator: Placebo
Patients in this group were administered the placebo for 8 weeks.
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Patients in this group were administered the placebo, 150ml/bag, times/day for 8 weeks.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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change of Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
Tidsramme: IBS-SSS was evaluated by patients at 0, 2, 4 ,6 and 8 weeks.
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Score less than 75 points was considered as in remission, 75~175 as mild, 175~300 as moderate, and over 300 as severe.
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IBS-SSS was evaluated by patients at 0, 2, 4 ,6 and 8 weeks.
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Serum markers regarding liver and kidney function
Tidsramme: at baseline and 8 weeks.
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at baseline and 8 weeks.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studiestol: xudong Tang, Ph.D, XiYuan Hospital of China Academy of Traditional Chinese Medicine
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
1. januar 2013
Primær færdiggørelse (Faktiske)
1. december 2015
Studieafslutning (Faktiske)
1. maj 2016
Datoer for studieregistrering
Først indsendt
27. juni 2016
Først indsendt, der opfyldte QC-kriterier
1. juli 2016
Først opslået (Skøn)
4. juli 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
5. september 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. september 2016
Sidst verificeret
1. juni 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Digestion-03
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
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Kliniske forsøg med Irritabel tyktarm med diarré
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Seoul National University HospitalUkendtSund og rask | Kronisk forstoppelse | Constipated Irritable Bowel Syndrome