Non-erosive Reflux DiseaseEarly Phase 1NCT05369884
Efficacy and Safety of WPQW Granule for Overlap of NERD and IBS-D
A Early Phase 1 study testing WPQW granule and WPQW granule simulant in people with Non-erosive Reflux Disease and Diarrhea-Predominant Irritable Bowel Syndrome, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-erosive Reflux Disease, Diarrhea-Predominant Irritable Bowel Syndrome
- What is being tested?
- WPQW granule and WPQW granule simulant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to May 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100091
Beihua Zhang, M.D, +86(010)62835248, zhangbeihua888@163.com
Fengyun Wang, M.D, +86(010)62835248, wfy811@163.com
About this study
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)
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.
Read the detailed 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.
- Being tested
- WPQW granule, WPQW granule simulant
- Medical subject headings
- Non-Erosive Reflux Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WPQW granuleDrug
WPQW granule, 2 sachets / time, 3 times / day.
WPQW granule simulantDrug
WPQW granule simulant, 2 sachets / time, 3 times / day.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: WPQW granule simulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline, 4 weeks during treatment period, 4 weeks during follow-up period
Secondary outcomes (4)
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.
Measured: 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
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.
Measured: baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
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.
Measured: 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
Hospital Anxiety and Depression Scale (HAD) score was used to evaluate the efficacy of experimental drug. Reduction in total score represented Improvement
Measured: baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start1 Dec 2021
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-erosive Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Nankai Hospital, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, The First Affiliated Hospital of Shanxi University of Traditional Chinese Medicine, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Yunnan Provinical Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Xudong Tang, M.D, Principal investigator, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369884
- Sponsor's protocol ID
- ZYYCXTD-C-202010
- Status last verified
- Dec 2021
- First submitted
- 8 May 2022
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05369884
- Acronym / sponsor ID
- ZYYCXTD-C-202010
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Tianjin Nankai Hospital, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, The First Affiliated Hospital of Shanxi University of Traditional Chinese Medicine, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Yunnan Provinical Hospital of Traditional Chinese Medicine
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: WPQW granuleOral 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. |
| Control group | Placebo comparator | Drug: WPQW granule simulantOral 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WPQW granuleWPQW granule, 2 sachets / time, 3 times / day. | Drug | Experimental group |
| WPQW granule simulantWPQW granule simulant, 2 sachets / time, 3 times / day. | Drug | Control group |
Primary outcome
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 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.
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 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.
4 secondary outcomes
Change of traditional Chinese Medicine syndrome score
Time frame: 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
Time frame: baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
Change of FGI-checklist score
Time frame: 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
Time frame: baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xudong Tang, M.D principal investigator
China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing WPQW granule and WPQW granule simulant in people with Non-erosive Reflux Disease and Diarrhea-Predominant Irritable Bowel Syndrome, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beihua Zhang, M.D (+86(010)62835248, zhangbeihua888@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.