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Efficacy and Safety of WPQW Granule for Overlap of NERD and IBS-D

NCT05369884 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2022-05-11

No results posted yet for this study

Summary

Non-erosive reflux disease（NERD）and Diarrhea-Predominant Irritable Bowel Syndrome（IBS-D）are both the common refractory gastrointestinal diseases. Patients, who suffered from overlapping symptoms of NERD and IBS-D, present more serious symptom manifestation, anxiety, and worse life quality than those with solely disease. There is lack of effective treatment for overlapping gastrointestinal symptoms. Traditional Chinese Medicine (TCM) syndrome differentiation and treatment has the advantages of overall regulation and individualized treatment, but lack of high-level evidence. The purpose of this study is to evaluate the efficacy and safety of WPQW granule for the treatment of NERD overlapping IBS-D.

Conditions

  • Non-erosive Reflux Disease
  • Diarrhea-Predominant Irritable Bowel Syndrome

Interventions

DRUG

WPQW granule

WPQW granule, 2 sachets / time, 3 times / day.

DRUG

WPQW granule simulant

WPQW granule simulant, 2 sachets / time, 3 times / day.

Sponsors & Collaborators

  • Tianjin Nankai Hospital

    collaborator OTHER

  • Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

    collaborator OTHER

  • The First Affiliated Hospital of Shanxi University of Traditional Chinese Medicine

    collaborator UNKNOWN

  • The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

    collaborator OTHER

  • Yunnan Provinical Hospital of Traditional Chinese Medicine

    collaborator OTHER

  • Xiyuan Hospital of China Academy of Chinese Medical Sciences

    lead OTHER

Principal Investigators

  • Xudong Tang, M.D · China Academy of Chinese Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2023-05-31
Completion
2023-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05369884 on ClinicalTrials.gov