Nonerosive Reflux DiseaseEarly Phase 1NCT04324138
Efficacy and Safety of Jianpi Qinghua Granules in Patients With Nonerosive Reflux Disease
A Early Phase 1 study testing Jianpi Qinghua granules in people with Nonerosive Reflux Disease, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
Nonerosive reflux disease (NERD) is a common refractory gastrointestinal disease. Proton pump inhibitors (PPIs), the first choice drug, have the following problems in clinical use: about 50 % of patients have no response to PPIs; the efficacy of simple acid suppression is poor; long-term use of PPIs can lead to… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nonerosive Reflux Disease
- What is being tested?
- Jianpi Qinghua granules
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2020to 31 Dec 2021
- 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
- Subjects diagnosed with non-erosive reflux disease
- Subjects who have a medical history of PPI with poor therapeutic effect
- Subjects aged between 18 and 70 years
- Subjects diagnosed with spleen deficiency damp-heat syndrome of traditional Chinese medicine
- Subjects who voluntarily signed written informed consent form
Who cannot join
- Subjects who have active peptic ulcer, gastrointestinal hemorrhage, severe dysplasia of gastric mucosa or suspected malignant change, achalasia or postoperative achalasia
- Subjects who have organic diseases of the digestive system (such as acute and chronic pancreatitis, cirrhosis, etc.), or systemic diseases that affect the gastrointestinal motility, such as hyperthyroidism, diabetes mellitus over 10 years, chronic renal insufficiency, spirit (the score of SAS and SDS shows severe anxiety or depression), nervous system diseases, etc
- Subjects who have severe organ diseases such as heart, liver and kidney (such as ALT, AST more than 2 times of normal value), hematopoietic system diseases and tumors
- Pregnant or lactating women
- Subjects who have a history of nervous system disease and mental disease
- Subjects who have a history of allergies to all the test drugs
- Subjects who are participating in other clinical trials or have participated in other clinical trials within 4 weeks
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiyuan Hospital
Beijing, Beijing Municipality, 100091
Beihua Zhang, doctorate
About this study
Official title: Efficacy and Safety of Jianpi Qinghua Granules in Patients With Nonerosive Reflux Disease:a Multicenter,Randomized, Double-blind, Placebo-controlled Clinical Trial
Nonerosive reflux disease (NERD) is a common refractory gastrointestinal disease. Proton pump inhibitors (PPIs), the first choice drug, have the following problems in clinical use: about 50 % of patients have no response to PPIs; the efficacy of simple acid suppression is poor; long-term use of PPIs can lead to indigestion, gastric polyps, atrophic gastritis, intestinal dysbacteriosis. Spleen Deficiency and Damp-heat Syndrome is one of the common clinical syndrome of NERD.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 Jianpi Qinghua Granules for treating NERD with spleen deficiency and damp heat syndrome.
Read the detailed description
Nonerosive reflux disease (NERD), representing about 70% of gastroesophageal reflux disease, is a common refractory gastrointestinal disease. Proton pump inhibitors (PPIs), the first choice drug, have the following problems in clinical use: about 50 % of patients have no response to PPIs; the efficacy of simple acid suppression is poor; long-term use of PPIs can lead to indigestion, gastric polyps, atrophic gastritis, intestinal dysbacteriosis. Spleen Deficiency and Damp-heat Syndrome is one of the common clinical syndrome of NERD.TCM syndrome differentiation and treatment has the advantages of overall regulation and individualized treatment, but lack of high-level evidence. NERD is the result of multifactorial pathogenicity. The reflux symptoms not only related to acid reflux, but also related to alkali, gas, mixed reflux, etc. The theory of Tongjiang put forward by Academician Dong Jianhua.Under the guidance of Academician Dong Jianhua, the research team create a prescription Jianpi Qinghua granule for treating NERD with spleen deficiency and damp-heat syndrome. The purpose of this study is to evaluate the efficacy and safety of Jianpi Qinghua Granules for treating NERD with spleen deficiency and damp heat syndrome based on a a multicenter,randomized, double-blind, placebo-controlled clinical trial.
On the basis of previous work, the project plans to establish sub centers in 3 Chinese hospitals, including78 patients with NERD and spleen deficiency and damp-heat syndrome. The therapeutic effects were evaluated from the following aspects: the VAS score of reflow and heartburn, the rate of discontinuation of antacids, the rate of recurrence of NERD symptoms, the score of TCM syndromes and the improvement of gastrointestinal function.
- Conditions
- Nonerosive Reflux Disease
- Being tested
- Jianpi Qinghua granules, Jianpi Qinghua placebo granules
- Keywords
- Nonerosive Reflux Disease, Traditional Chinese Medicine, Randomized placebo controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jianpi Qinghua granulesDrug
Also called experimental drugs
3 times a day and 1 hour after a meal, for 4 weeks
Jianpi Qinghua placebo granulesDrug
Also called placebo
3 times a day and 1 hour after a meal, for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Jianpi Qinghua granules, 3 times a day and 1 hour after a meal Receives: Drug: Jianpi Qinghua granules |
| Control group | Sham comparator | Jianpi Qinghua placebo granules(inclued 5% of experimental drug),3 times a day and 1 hour after a meal Receives: Drug: Jianpi Qinghua placebo granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of visual analogue (VAS) score of reflux symptoms and heartburn
During the treatment, the patients recorded the reflux and heartburn attacks (attack times and duration) within 24 hours every day on the symptom diary card, and VAS scores were performed on the reflux and heartburn symptoms. The average score of each symptom in the past week was calculated. The decrease rate of symptom score≥50% from baseline was recorded as response after 1 week of treatment , and the number of response weeks was more than 50% of the whole treatment period, which was considered effective.
Measured: week 1, week 2，week 3, week 4 during treatment period, week 6 and week 8 during follow-up period
Secondary outcomes (6)
Change of secondary symptom score
The secondary symptoms of Non-cardiogenic chest pain, epigastric pain, upper abdominal burning sensation, belching, cough, asthma, Pharyngeal different feeling were recorded. Each symptom was scored for frequency (score, 0-5) and severity (score, 0-5). A higher score represented more frequency and severity. Change of total symptom score from baseline was compared between treatment group and control group at different time windows . Reduction in total symptom score represented Improvement
Measured: week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
Change of traditional Chinese Medicine syndrome score
The symptoms related to spleen deficiency damp-heat syndrome 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. Change of the syndrome score from baseline was compared between treatment group and control group at different time windows. Reduction in syndrome score represented Improvement
Measured: week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
Change of gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) scale score
Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) scale was used to evaluate the quality of life of patients with non-erosive reflux disease. Change of GERD-HRQL scale total score (0-55) from baseline was compared between treatment group and control group at different time windows. Reduction in total score represented Improvement
Measured: week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
Change of patient ported outcome (PRO) for chronic gastrointestinal disease scale score
Patient ported outcome (PRO) for chronic gastrointestinal disease scale was used to evaluate the efficacy of experimental drug. Change of PRO scale total score (0-152) from baseline was compared between treatment group and control group at different time windows. Reduction in total score represented Improvement
Measured: week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
Change of self-rating anxiety scale (SAS) score
Self-rating anxiety scale (SAS) was used to evaluate the efficacy of experimental drug. Change of SAS total score (20-80) from baseline was compared between treatment group and control group at different time windows. Reduction in total score represented Improvement
Measured: week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
Change of self-rating depression scale (SDS) score
Self-rating depression scale (SDS) was used to evaluate the efficacy of experimental drug. Change of SAS total score (20-80) from baseline was compared between treatment group and control group at different time windows. Reduction in total score represented Improvement
Measured: 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 posted27 Mar 2020
- Study start15 Jul 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nonerosive 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
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Liaoning University of Traditional Chinese Medicine, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- beihua zhang, M.D, Study chair, Xiyuan Hospital of China Academy of Chinese Medical Sciencesguang bai, M.D, Study director, Liaoning University of Traditional Chinese Medicinewei wang, M.M, Study director, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324138
- Sponsor's protocol ID
- 2019YFC1709602-
- Status last verified
- Apr 2021
- First submitted
- 25 Mar 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang T, Bai G, Wang W, Liu L, Zhou Z, Ji H, Zhang B, Tang X. Efficacy and safety of Jianpi Qinghua granules for non-erosive reflux disease with spleen deficiency and damp-heat syndrome: a multicenter, randomized, double-blind, placebo-controlled clinical trial. Front Nutr. 2025 Jan 7;11:1509931. doi: 10.3389/fnut.2024.1509931. eCollection 2024.
PubMed 39839278
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Jianpi Qinghua Granules in Patients With Nonerosive Reflux Disease:a Multicenter,Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04324138
- Acronym / sponsor ID
- 2019YFC1709602-
- Conditions
- Nonerosive Reflux Disease
- Keywords
- Nonerosive Reflux Disease, Traditional Chinese Medicine, Randomized placebo controlled trial
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Liaoning University of Traditional Chinese Medicine, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 27 Mar 2020 (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.
Nonerosive reflux disease (NERD) is a common refractory gastrointestinal disease. Proton pump inhibitors (PPIs), the first choice drug, have the following problems in clinical use: about 50 % of patients have no response to PPIs; the efficacy of simple acid suppression is poor; long-term use of PPIs can lead to indigestion, gastric polyps, atrophic gastritis, intestinal dysbacteriosis. Spleen Deficiency and Damp-heat Syndrome is one of the common clinical syndrome of NERD.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 Jianpi Qinghua Granules for treating NERD with spleen deficiency and damp heat syndrome.
Detailed description
Nonerosive reflux disease (NERD), representing about 70% of gastroesophageal reflux disease, is a common refractory gastrointestinal disease. Proton pump inhibitors (PPIs), the first choice drug, have the following problems in clinical use: about 50 % of patients have no response to PPIs; the efficacy of simple acid suppression is poor; long-term use of PPIs can lead to indigestion, gastric polyps, atrophic gastritis, intestinal dysbacteriosis. Spleen Deficiency and Damp-heat Syndrome is one of the common clinical syndrome of NERD.TCM syndrome differentiation and treatment has the advantages of overall regulation and individualized treatment, but lack of high-level evidence. NERD is the result of multifactorial pathogenicity. The reflux symptoms not only related to acid reflux, but also related to alkali, gas, mixed reflux, etc. The theory of Tongjiang put forward by Academician Dong Jianhua.Under the guidance of Academician Dong Jianhua, the research team create a prescription Jianpi Qinghua granule for treating NERD with spleen deficiency and damp-heat syndrome. The purpose of this study is to evaluate the efficacy and safety of Jianpi Qinghua Granules for treating NERD with spleen deficiency and damp heat syndrome based on a a multicenter,randomized, double-blind, placebo-controlled clinical trial.
On the basis of previous work, the project plans to establish sub centers in 3 Chinese hospitals, including78 patients with NERD and spleen deficiency and damp-heat syndrome. The therapeutic effects were evaluated from the following aspects: the VAS score of reflow and heartburn, the rate of discontinuation of antacids, the rate of recurrence of NERD symptoms, the score of TCM syndromes and the improvement of gastrointestinal function.
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: Jianpi Qinghua granulesJianpi Qinghua granules, 3 times a day and 1 hour after a meal |
| Control group | Sham comparator | Drug: Jianpi Qinghua placebo granulesJianpi Qinghua placebo granules(inclued 5% of experimental drug),3 times a day and 1 hour after a meal |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects diagnosed with non-erosive reflux disease
- Subjects who have a medical history of PPI with poor therapeutic effect
- Subjects aged between 18 and 70 years
- Subjects diagnosed with spleen deficiency damp-heat syndrome of traditional Chinese medicine
- Subjects who voluntarily signed written informed consent form
Key exclusion criteria (7 listed)
- Subjects who have active peptic ulcer, gastrointestinal hemorrhage, severe dysplasia of gastric mucosa or suspected malignant change, achalasia or postoperative achalasia
- Subjects who have organic diseases of the digestive system (such as acute and chronic pancreatitis, cirrhosis, etc.), or systemic diseases that affect the gastrointestinal motility, such as hyperthyroidism, diabetes mellitus over 10 years, chronic renal insufficiency, spirit (the score of SAS and SDS shows severe anxiety or depression), nervous system diseases, etc
- Subjects who have severe organ diseases such as heart, liver and kidney (such as ALT, AST more than 2 times of normal value), hematopoietic system diseases and tumors
- Pregnant or lactating women
- Subjects who have a history of nervous system disease and mental disease
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 |
|---|---|---|
| Jianpi Qinghua granulesAlso: experimental drugs3 times a day and 1 hour after a meal, for 4 weeks | Drug | Experimental group |
| Jianpi Qinghua placebo granulesAlso: placebo3 times a day and 1 hour after a meal, for 4 weeks | Drug | Control group |
Primary outcome
Change of visual analogue (VAS) score of reflux symptoms and heartburn
Time frame: week 1, week 2，week 3, week 4 during treatment period, week 6 and week 8 during follow-up period
During the treatment, the patients recorded the reflux and heartburn attacks (attack times and duration) within 24 hours every day on the symptom diary card, and VAS scores were performed on the reflux and heartburn symptoms. The average score of each symptom in the past week was calculated. The decrease rate of symptom score≥50% from baseline was recorded as response after 1 week of treatment , and the number of response weeks was more than 50% of the whole treatment period, which was considered effective.
6 secondary outcomes
Change of secondary symptom score
Time frame: week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
Change of traditional Chinese Medicine syndrome score
Time frame: week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
Change of gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) scale score
Time frame: week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
Change of patient ported outcome (PRO) for chronic gastrointestinal disease scale score
Time frame: week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
Change of self-rating anxiety scale (SAS) score
Time frame: week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
Change of self-rating depression scale (SDS) score
Time frame: 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 8 Apr 2021.
- Derived from this study: PubMed 39839278Zhang T, Bai G, Wang W, Liu L, Zhou Z, Ji H, Zhang B, Tang X. Efficacy and safety of Jianpi Qinghua granules for non-erosive reflux disease with spleen deficiency and damp-heat syndrome: a multicenter, randomized, double-blind, placebo-controlled clinical trial. Front Nutr. 2025 Jan 7;11:1509931. doi: 10.3389/fnut.2024.1509931. eCollection 2024.
- Individual participant dataSharing planned: No
Related trials for Nonerosive Reflux Disease
Recruiting
New Topical tReatment Options for Symptomatic patiEnts With Nonerosive gastroesophageaL Reflux dIsease (The RELIEF Trial)
GERD (Gastroesophageal Reflux Disease), NERD
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.
beihua zhang, M.D study chair
Xiyuan Hospital of China Academy of Chinese Medical Sciences
guang bai, M.D study director
Liaoning University of Traditional Chinese Medicine
wei wang, M.M study director
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
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 Jianpi Qinghua granules in people with Nonerosive Reflux Disease, 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 5 inclusion and 7 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 8 Apr 2021. 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 (VAS) score of reflux symptoms and heartburn (time frame: week 1, week 2，week 3, week 4 during treatment period, week 6 and week 8 during follow-up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04324138, which also lists 1 linked publication.
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 8 Apr 2021.