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

Non-erosive Reflux Disease Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05369884
• Other study ID #: ZYYCXTD-C-202010
• Status: Recruiting
• Phase: Early Phase 1
• Start date: December 1, 2021
• Est. completion date: May 2023

Study information

• Verified date: December 2021
• Source: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Contact: Beihua Zhang, M.D
• Phone: +86(010)62835248
• Email: zhangbeihua888[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Gastroesophageal reflux disease (GERD) is a chronic relapsing acid-peptic disorder that is caused by the reflux of gastric or duodenum content. Non-erosive reflux disease（NERD）, which account for 70%, is the most common type of GERD in the Asian population. Diarrhea-Predominant Irritable Bowel Syndrome（IBS-D）is the mainly subtype of IBS, and the prevalence was found to be 46% in IBS. Both diseases aforementioned are common and frequent chronic diseases in the world, and the pathogenesis of which has not been fully defined. Current studies have shown that GERD can present in patients with IBS, vice versa. Up to 79% of patients with IBS co-exist with GERD-like symptoms, and 71% of patients with GERD co-exist with IBS-like symptoms. For those patients, they suffer from more serious symptom manifestation, anxiety, and worse life quality those with solely disease. The diagnosis and treatment of Functional gastrointestinal disorders (FGIDs) mostly based on the idea of segmental diagnosis and single-target therapy in modern medicine, and there is lack of effective treatment for overlapping gastrointestinal symptoms. The advantages of holistic diagnosis therapy and individualized treatment in Traditional Chinese Medicine（TCM）have attracted international attention, but there is still lack of high-level evidence-based medical evidence for the treatment of symptom overlap in FGIDs in TCM. In this study, we propose to conduct a multicenter, randomized, double-blind, placebo-controlled clinical study of WPQW granule for the treatment of NERD overlapping IBS-D to evaluate the efficacy and safety of WPQW granule with the aim of obtaining high-level evidence-based medical evidence.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Patients diagnosed with NERD and IBS-D simultaneously

2. Patients who present cardinal symptoms like reflux, heartburn, abdominal pain/bloating, diarrhea, etc

3. Patients diagnosed with syndrome of intermingled cold and heat of traditional Chinese medicine

4. Patients have informed consent and are willing to receive corresponding treatment

Exclusion Criteria:

1. Patients with hiatal hernia

2. Patients with upper gastrointestinal bleeding, peptic ulcer, gastrointestinal tumor, chronic atrophic gastritis with dysplasia

3. 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

4. Patients with neurological disease or psychiatric impairment like severe anxiety, depression requiring long-term drug treatment

5. Patients who cannot stop taking acid suppressants for a long time

6. Alcohol or drug dependency or abuse

7. Pregnant or lactating women

8. Patients who have a history of allergies to all the test drugs

9. Patients who are participating in other clinical trials or have participated in other clinical trials within 3 months

10. Patients who, in the opinion of the investigator, are not suitable to participate in clinical trial

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	Xiyuan Hospital of China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (6)

Lead Sponsor	Collaborator
Xiyuan Hospital of China Academy of Chinese Medical Sciences	The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, the first affiliated hospital of Liaoning university of traditional Chinese medicine, The First Affiliated Hospital of Shanxi University of Traditional Chinese Medicine, Tianjin Nankai Hospital, Yunnan Provinical Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change of traditional Chinese Medicine syndrome score	The symptoms related to syndrome of intermingled cold and heat were scored. The cardinal symptom was scored 0, 2, 4, 6 and the secondary symptom scored 0, 1, 2, 3 respectively according to severity of each symptom. Total symptom score represented the syndrome score. Reduction in syndrome score represented Improvement.	baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
Secondary	Change of 36-item short-form (SF-36) score	Health status was evaluated by a 36-item short-form (SF-36) containing eight health concepts. If the score descends, it indicates that the patient's condition has improved.	baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
Secondary	Change of FGI-checklist score	A 20-item FGI-checklist was used to evaluate comprehensive symptom severity of Functional Gastrointestinal Disorder (FGID), which covering esophageal, dyspeptic and bowel symptoms. If the score descends, it indicates that the patient's condition has improved.	baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
Secondary	Change of Hospital Anxiety and Depression Scale (HAD) score	Hospital Anxiety and Depression Scale (HAD) score was used to evaluate the efficacy of experimental drug. Reduction in total score represented Improvement	baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period