NCT05369884

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of WPQW Granule for Overlap of Non-Erosive Reflux Disease(NERD) and Diarrhea Predominant Diarrhea Irritable Bowel Syndrome(IBS-D)

Status unknown EARLY_PHASE1 Last updated 10 May 2022

What this trial tests

EARLY_PHASE1 trial testing WPQW granule in Non-erosive Reflux Disease in 216 participants. Status unknown.

Timeline

1 December 2021

Primary endpoint
1 May 2023

1 May 2023

Quick facts

Lead sponsor	Xiyuan Hospital of China Academy of Chinese Medical Sciences
Phase	EARLY_PHASE1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	216
Start date	1 December 2021
Primary completion	1 May 2023
Estimated completion	1 May 2023
Sites	1 location across China

Drugs / interventions tested

• WPQW granule — full drug profile →
• WPQW granule simulant — full drug profile →

Conditions studied

• Non-erosive Reflux Disease — all drugs for Non-erosive Reflux Disease →
• Diarrhea-Predominant Irritable Bowel Syndrome — all drugs for Diarrhea-Predominant Irritable Bowel Syndrome →

Sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Who can join

Adults 18 to 70, any sex, with Non-erosive Reflux Disease or Diarrhea-Predominant Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change of visual analogue scale (VAS) score of symptoms of reflux and heartburn
  Time frame: baseline, 4 weeks during treatment period, 4 weeks during follow-up period
  During the medication period, the patients recorded the reflux and heartburn episodes (frequency and duration) within 24 hours per day on the symptom diary card, and VAS scores for reflux and heartburn symptoms was calculated as the mean score of each symptom in the past week. The episodes in the week before medication were used as the baseline, the mean score of any symptom decreased ≥50% from th
• Change of visual analogue scale (VAS) score of symptoms of abdominal pain and diarrhea
  Time frame: baseline, 4 weeks during treatment period, 4 weeks during follow-up period
  During the medication period, the patients recorded the of abdominal pain (pain severity and frequency) and diarrhea (stool consistency and frequency based on Bristol stool form scale) within 24 hours per day on the symptom diary card. VAS score was conducted for the most severe abdominal pain, and the mean score was calculated for each week, with the week of episodes prior to medication administr

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.