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Stigma and Efficacy of Zhizhu Kuanzhong Capsules

8. august 2022 opdateret af: Shengliang Chen, RenJi Hospital

Stigma and Efficacy of Zhizhu Kuanzhong Capsules Versus Doxepin in the Treatment of Refractory Functional Dyspepsia: a Randomized Controlled Trial

Antidepressants are effective in patients with functional dyspepsia (FD), however, the stigma related with FD and antidepressants could affect treatment adherence and efficacy. Zhi Zhu Kuan Zhong capsules (ZZKZ), a traditional Chinese medicine fomula, showed therapeutic potential for FD. The study was designed to investigate whether ZZKZ could alleviate stigma in FD and obtain identical effects in patients with refractory FD.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Patients with dyspepsia have poor quality of life and emotional distress. The pathophysiology of FD is complex and multifactorial, including factors related to central nervous system and peripheral sensory system. Abundant drugs have been trialed to treat FD patients, but the treatment options remain limited and far from optimal. Antidepressants were beneficial in the treatment of FD. But the antidepressant prescriptions often aggravate the stigma of patients with FD, hinder doctor-patient communication, and reduce treatment compliance. Some patients with strong stigmatized feelings towards antidepressants refused to take the medications, and stigma related with antidepressants could ultimately affect the efficacy of FD. Zhizhu Kuanzhong capsules (ZZKZ), a commonly used traditional Chinese medicine (TCM) formula, had shown effectiveness in relieving dyspeptic symptoms. It has a long culture and history in promoting the function of brain and GI tract in whole, which is widely accepted by populations who were familiar with TCM. The study was designed to observe whether ZZKZ could alleviate stigma of patients and obtain identical effects in patients with FD, therefore provide a new insight in the treatment of FD.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

76

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Kina
    • Shanghai
      • Shanghai, Shanghai, Kina
        • Rekruttering
        • Renji Hospital
        • Kontakt:
          • Chen, PhD

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:

  • The inclusion criteria includes:
  • 18-70 years old;
  • education level higher than middle school;
  • met the Rome IV criteria for FD;
  • absence of abnormalities on physical examination, laboratory tests (including a routine blood test, blood glucose, and liver function examination), and abdominal imaging and GI endoscopy within 6 months;
  • absence of Helicobacter pylori infection;
  • signed written informed consent for participation in the study.

Exclusion Criteria:

  • The exclusion criteria includes:
  • evidence of organic digestive diseases;
  • diabetes, cancer and other diseases might affect GI function;
  • pregnancy, lactation or breastfeeding;
  • a history of allergic reaction to any of the drugs used in the study;
  • participation in other clinical trials in the previous 3 months.

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Zhizhu Kuanzhong（ZZKZ） group
Patients in ZZKZ group were given ZZKZ (2 capsules tid) plus omeprazole (20 mg bid). ZZKZ was applied after each meal. Omeprazole was applied twice daily, before breakfast and supper.
Medicin: Zhizhu Kuanzhong capsules (ZZKZ)
FD patients were treated with ZZKZ and omeprazole for 4 weeks.
Andre navne:
  • Traditionel kinesisk medicin
Aktiv komparator: Doxepin group
Patients in doxepin group were given doxepin (25 mg tid) plus omeprazole (20 mg bid). Doxepin was applied after each meal. Omeprazole was applied twice daily, before breakfast and supper.
Medicin: Doxepin Hydrochloride (Doxepin)
FD patients were treated with doxepin and omeprazole for 4 weeks.
Andre navne:
  • Antidepressiva
  • Neuromodulators

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes of Leeds Dyspepsia Questionnaire (LDQ) scores at 4 weeks from baseline were obtained to assess the dyspepsia condition after treatment.
Tidsramme: 4 weeks
The LDQ scores of 0-4 were classified as very mild dyspepsia, 5-8 as mild dyspepsia, 9-15 as moderate dyspepsia, and >15 as severe or very severe dyspepsia.
4 weeks
Changes of Patient Health Questionnaire-9 (PHQ-9) scores at 4 weeks from baseline were obtained to assess the depression condition after treatment.
Tidsramme: 4 weeks
The PHQ-9 scores of 0-4 were classified as none or minimal depression, 5-9 as mild, 10-14 as moderate, 15-19 as moderately severe, and ≥20 as severe depression.
4 weeks
Changes of Generalized Anxiety Questionnaire-7 (GAD-7) scores at 4 weeks from baseline were obtained to assess the anxiety condition after treatment.
Tidsramme: 4 weeks
The GAD-7 scores of 0-4 were classified as the absence of anxiety, 5-9 as mild, 10-14 as moderate, and ≥15 as severe.
4 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes of Internalized stigma scale (ISS) scores at 4 weeks from baseline were obtained to assess the internalized stigma of patients after treatment.
Tidsramme: 4 weeks
The Internalized stigma scale (ISS) is a 24-item self-report questionnaire with items ranked on a 4-point Likert scale (strongly disagree = 1 to strongly agree = 4 points). The ISS scores are calculated by summing the values for each item and dividing by the number of questions answered for each scale. Higher scores indicate higher levels of ISS. The ISS scores of 1-2 were classifies as minimal, 2-2.5 as mild, 2.5-3 as moderate, 3-4 as severe.
4 weeks
Changes of Perceived stigma scale (PSS) scores at 4 weeks from baseline were obtained to assess the perceived stigma of patients after treatment.
Tidsramme: 4 weeks
The Perceived stigma scale (PSS) is a 10-item questionnaire with items ranked on a 5-point Likert scale (seldom = 1 to always = 5 points). The scores are calculated by summing the values for each item and dividing by the number of questions answered for each scale. Minimum to maximum score is 1 to 5 points. Higher scores indicate higher levels of PSS. The PSS scores of 1-2 were classifies as minimal, 2-3 as mild, 3-4 as moderate, 4-5 as severe.
4 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

RenJi Hospital

Efterforskere

  • Ledende efterforsker: Sheng-Liang Chen, PhD, Division of Gastroenterology and Hepatology, Renji Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. februar 2021

Primær færdiggørelse (Forventet)

1. august 2022

Studieafslutning (Forventet)

1. september 2022

Datoer for studieregistrering

Først indsendt

26. september 2021

Først indsendt, der opfyldte QC-kriterier

23. oktober 2021

Først opslået (Faktiske)

4. november 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. august 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. august 2022

Sidst verificeret

1. august 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RJYYTCM

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