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Dose Escalation Trial of Traditional Chinese Medicine for Irritable Bowel Syndrome (TCM- IBS) (TCM-IBS)

25. februar 2022 opdateret af: Brian Berman, University of Maryland, Baltimore

Dose Escalation Trial Of Traditional Chinese Medicine For Irritable Bowel Syndrome

The purpose of this study is to determine whether a 20- herb formulation, as a well characterised extract, is efficacious in treating irritable bowel syndrome (IBS) and also to identify efficacious and safe dosage of the formulation in treating IBS.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The Specific aims of the project are:

  1. To determine whether a 20- herb formulation improves pain/ discomfort and disturbed bowel frequency in patients with Irritable Bowel Syndrome who have been disappointed with current conventional Western medicine.
  2. To identify an optimal dosage of the 20- herb formulation that is safe and well tolerated for up to 8 weeks of treatment, among 2 dosages. This is determined by relief of symptoms of IBS in a dose escalation, placebo-controlled double- blind randomized clinical trial, in conjunction with indices of safety and tolerability.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

104

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Hong Kong
      • Shatin, Hong Kong
        • Medical Gastroenterelogy Clinic Of the Prince Of Wales, Chinese University of Hong Kong

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 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age 18- 75
  • All IBS patients attending the Gastroenterology Clinic of the Prince Of Wales Hospital of Hong Kong.

  • IBS diagnosed by Rome III criteria:

    • Recurrent abdominal pain or discomfort at least three days per month in the previous three months
    • Symptoms onset at least six months prior to diagnose

    • Pain or discomfort associated with two or more of the following:

      1. Improvement with defecation
      2. Onset associated with change in frequency of stool
      3. Onset associated with a change in form (appearance) of stool
  • Normal colonic evaluation (colonoscopy or barium enema) in past 5 years
  • No "global symptom improvement" as rated by patients (see below) at screening and during the two- week run- in period to baseline

  • Normal full blood count, liver function test and renal function test.

    • Informed written consent for participation into study.
    • Ethical approval will be obtained from the Joint CUHK-NTEC Clinical Research Ethics Committee as well as the IRB of UMB.

Exclusion Criteria:

  • Past or present history of organic disease of gastrointestinal tract (e.g. colorectal cancer, advanced colonic polyp, celiac disease, inflammatory bowel disease, peptic ulcer and previous gastrointestinal surgery). (Note: those with polyps removed during colonoscopy can be included, as long as no known polyps remained.
  • Systemic diseases that cause diarrhea or constipation (e.g. thyroid disease, diabetic neuropathy)
  • Lactose intolerance
  • Severe liver disease (e.g. cirrhosis, chronic active hepatitis)
  • Renal impairment (serum creatinine level > 150mmol/L)
  • Women who are pregnant, lactating or not practicing proper contraception
  • Known hypersensitivity to herbal medicine
  • Concommitant use of prescription antidepressant medication
  • Current alcoholism and drug use
  • Current psychiatric illness or dementia
  • Fever or severe illness at baseline (week 0).

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 20-herb formulation
Active herb
Medicin: 20-herb formulation
Two daily dosages will be investigated. The lowest dosage condition will be 17gm daily, followed by an escalation to 34gm. Participants will be treated for 8 weeks
Placebo komparator: Placebo
Placebo herb formulation
Medicin: Placebo
Placebo herb formulation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Global IBS symptom improvement
Tidsramme: 8 weeks
The primary endpoint for this study is the efficacy at the 8 week followup visit of the herbal formulations, which is defined by the patient's global assessment of the IBS symptoms.
8 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Bowel Symptom Scale (BSS):
Tidsramme: 8 weeks
The Bowel Symptom Scale will be used to assess changes in individual IBS and global IBS symptoms during the course of illness.
8 weeks
SF-36
Tidsramme: 8 weeks
Quality of Life generic (SF-36), will be used for assessment of quality of life in response to treatment.
8 weeks
IBS-QoL
Tidsramme: 8 weeks
Disease-specific (IBS-QoL) will be used for assessment of quality of life in response to treatment.
8 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Maryland, Baltimore

Samarbejdspartnere

Chinese University of Hong Kong
National Center for Complementary and Integrative Health (NCCIH)

Efterforskere

  • Ledende efterforsker: Brian M Berman, MD, University of Maryland

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. maj 2008

Primær færdiggørelse (Faktiske)

1. marts 2011

Studieafslutning (Faktiske)

1. juni 2011

Datoer for studieregistrering

Først indsendt

28. marts 2010

Først indsendt, der opfyldte QC-kriterier

2. oktober 2017

Først opslået (Faktiske)

4. oktober 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. marts 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. februar 2022

Sidst verificeret

1. februar 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HP-00041236
  • 1U19AT003266-01 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Irritabelt tarmsyndrom

Kliniske forsøg med 20-herb formulation

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

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Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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