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

NCT05369884 | Unknown Early Phase 1 DMC

• 1 other identifier: ZYYCXTD-C-202010
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change of visual analogue scale (VAS) score of symptoms of reflux and heartburn

  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 the baseline was recorded as response after weekly treatment, and the number of response weeks was considered effective if it was greater than 50% of the weeks of the whole treatment period.

  baseline, 4 weeks during treatment period, 4 weeks during follow-up period

• Change of visual analogue scale (VAS) score of symptoms of abdominal pain and diarrhea

  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 administration as the baseline. It was considered effective when the weekly mean score decrease of at least 30% from baseline and the days of at least once type 6 or type 7 stool Bristol stool form every week decrease of at least 30% from baseline, referring to the efficacy evaluation of the technical guidelines for clinical studies of Chinese medicine for IBS published in 2017.

  baseline, 4 weeks during treatment period, 4 weeks during follow-up period

Secondary Outcomes (4)

• Change of traditional Chinese Medicine syndrome score

  baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period

• Change of 36-item short-form (SF-36) score

  baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period

• Change of FGI-checklist score

  baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period

• Change of Hospital Anxiety and Depression Scale (HAD) score

  baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period

Study Arms (2)

Experimental group

EXPERIMENTAL

Oral administration of WPQW granule with warm water，2 sachets each time, 3 times a day, 1.5-2 hours after a meal. The medication period was 4 weeks.

Drug: WPQW granule

Control group

PLACEBO COMPARATOR

Oral administration of WPQW granule simulant，which containing 5% WPQW granule，with warm water，2 sachets each time, 3 times a day, 1.5-2 hours after a meal. The medication period was 4 weeks.

Drug: WPQW granule simulant

Interventions

WPQW granule DRUG

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

Experimental group

WPQW granule simulant DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with NERD and IBS-D simultaneously
• Patients who present cardinal symptoms like reflux, heartburn, abdominal pain/bloating, diarrhea, etc
• Patients diagnosed with syndrome of intermingled cold and heat of traditional Chinese medicine
• Patients have informed consent and are willing to receive corresponding treatment

You may not qualify if:

• Patients with hiatal hernia
• Patients with upper gastrointestinal bleeding, peptic ulcer, gastrointestinal tumor, chronic atrophic gastritis with dysplasia
• Patients with other serious organic diseases, such as acute cardiovascular disease, acute and chronic pancreatitis, cirrhosis, abnormal liver function (transaminases more than 1.5 times of normal value), abnormal thyroid function, diabetes mellitus with a history of more than 10 years, chronic renal insufficiency, hematologic disorders, and hematologic disorders, etc
• Patients with neurological disease or psychiatric impairment like severe anxiety, depression requiring long-term drug treatment
• Patients who cannot stop taking acid suppressants for a long time
• Alcohol or drug dependency or abuse
• Pregnant or lactating women
• Patients who have a history of allergies to all the test drugs
• Patients who are participating in other clinical trials or have participated in other clinical trials within 3 months
• Patients who, in the opinion of the investigator, are not suitable to participate in clinical trial

Sponsors & Collaborators

• Xiyuan Hospital of China Academy of Chinese Medical Sciences: lead
• Tianjin Nankai Hospital: collaborator
• Affiliated Hospital of Liaoning University of Traditional Chinese Medicine: collaborator
• The First Affiliated Hospital of Shanxi University of Traditional Chinese Medicine: collaborator
• The First Affiliated Hospital of Henan University of Traditional Chinese Medicine: collaborator
• Yunnan Provinical Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100091, China

RECRUITING

MeSH Terms

Conditions

Non-Erosive Reflux Disease

Condition Hierarchy (Ancestors)

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Xudong Tang, M.D

  China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beihua Zhang, M.D

CONTACT

+86(010)62835248; zhangbeihua888@163.com

Fengyun Wang, M.D

CONTACT

+86(010)62835248; wfy811@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and investigators were masked to group assignment. An independent statistician was masked for the data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2022
• First Posted: May 11, 2022
• Study Start: December 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: May 11, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)