Nonerosive Reflux DiseasePhase 3NCT04340297
Tongjiang Series Prescription Combined With PPIs Descending Ladder Withdrawal in Treating Nonerosive Reflux Disease
A Phase 3 study testing Tongjiang series prescription(Tongjiang granules, Jianpi Qinghua granules and Wenpi Qingwei granules) and Acid inhibitors 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 preferred drug, have poor response, single target and poor acid inhibition effect in some patients in clinical application. Long-term use of PPI can lead to many side effects, even dependency. 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?
- Tongjiang series prescription(Tongjiang granules, Jianpi Qinghua granules and Wenpi Qingwei granules) and Acid inhibitors
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2020to 31 Dec 2021
- Phase
- Phase 3
- 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
- 1. It meets the diagnostic criteria of nonerosive reflex disease(NERD)
- 2. Patients with PPIs who are effective for more than 8 weeks and relapse after discontinuation
- 3. Age between 18 and 70 years old
- 4. It meets the diagnostic criteria of liver-stomach depression-heat syndrome, spleen deficiency damp-heat syndrome and cold-heat complicated syndrome of traditional Chinese medicine
- 5. Patients have informed consent and are willing to receive corresponding treatment
Who cannot join
- 1. Patients with active peptic ulcer, gastrointestinal hemorrhage, severe dysplasia of gastric mucosa or suspected malignant change, achalasia or postoperative achalasia
- 2. There are other 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
- 3. Patients with 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
- 4. Pregnant and lactating women
- 5. Patients with history of nervous system disease and mental disease
- 6. People with a history of allergies to all the test drugs
- 7. 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 of China Academy of Chinese Medical Sciences
Beijing
Yingpan Zhao, M.D., +86(010)62835101, zypzyp1984@163.com
About this study
Official title: Randomized Double-Blind Clinical Trial of Tongjiang Theory and Syndrome Differentiation Serial Prescriptions Combined With Proton Pump Inhibitors(PPIs)Descending Ladder Withdrawal for the Treatment of Nonerosive Reflux Disease.
Nonerosive Reflux Disease (NERD) is a common refractory gastrointestinal disease. Proton Pump Inhibitors (PPIs), the preferred drug, have poor response, single target and poor acid inhibition effect in some patients in clinical application. Long-term use of PPI can lead to many side effects, even dependency. The main Traditional Chinese Medicine (TCM)syndrome types of NERD are liver-stomach depression-heat syndrome, spleen deficiency damp-heat syndrome and cold-heat complicated syndrome. TCM syndrome differentiation treatment has the advantages of overall regulation and individualized treatment. The purpose of this study is to evaluate the safety and efficacy advantages of syndrome differentiation series prescription combined with PPIs descending ladder withdrawal in the treatment of patients who use PPIs for a long time that can not stop, and to solve the problems of multiple side effects and dependency caused by long-term use of PPIs.
Read the detailed description
Nonerosive Reflux Disease (NERD) accounts for about 70% of Gastroesophageal Reflux Disease (GERD), which is a common refractory gastrointestinal disease. Proton Pump Inhibitors (PPIs), the preferred treatment, have the following problems in clinical use: about 50% of patients respond to PPIs only partially or not at all; PPIs has a single target, and the effect of acid suppression alone is poor; long term use of PPIs can lead to dyspepsia, fundic gland polyp, atrophic gastritis, intestinal flora disorders, and even dependency. Liver-stomach depression-heat syndrome, spleen deficiency damp-heat syndrome and cold-heat complicated syndrome account for 80%-91% of NERD's Traditional Chinese Medicine (TCM) syndrome. TCM syndrome differentiation treatment has the advantages of overall regulation and individualized treatment, but it lacks high-level evidence-based medicine evidence. On the basis of previous work, the project plans to establish sub centers in 6 Chinese hospitals, including 180 patients with NERD who meet the requirements to carry out a multicenter, randomized, double-blind, placebo-controlled clinical study, in which 90 subjects in the experimental group received the treatment of syndrome differentiation series of prescriptions combined with PPIs descending ladder withdrawal, and 90 subjects in the control group received the treatment of placebo combined with PPIs descending ladder withdrawal. 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. The purpose of this study is to evaluate the efficacy advantage and safety of Tongjiang series prescription combined with PPIs descending ladder withdrawal compared with PPIs descending ladder withdrawal alone for patients who use PPIs for a long time that can not stop, so as to obtain evidence-based medical evidence of high-quality TCM syndrome differentiation treatment of NERD, and form an effective and popularized treatment plan to solve the problems of various side effects and dependency caused by long-term use of PPIs.
- Conditions
- Nonerosive Reflux Disease
- Being tested
- Tongjiang series prescription(Tongjiang granules, Jianpi Qinghua granules and Wenpi Qingwei granules), Acid inhibitors, Placebo
- Keywords
- Traditional Chinese medicine, Tongjiang series prescription, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongjiang series prescription(Tongjiang granules, Jianpi Qinghua granules and Wenpi Qingwei granules)Drug
According to the syndrome differentiation of TCM, Tongjiang granules are taken orally by patients with liver-stomach depression-heat syndrome, Jianpi Qinghua granules are taken orally by patients with spleen deficiency damp-heat syndrome, Wenpi Qingwei granules are taken orally by patients with cold-heat complicated syndrome, 1 bag per time, 3 times a day and 1 hour after a meal.
Acid inhibitorsDrug
In the 1-2 weeks, acid inhibitor (PPI) was reduced from the dose before entering the group to half of the dose, once a day, before going to bed; in the 3-4 weeks, acid inhibitor was changed from PPI to famotidine tablets, 20mg each time, before going to bed; in the 5-6 weeks, all acid inhibitors were stopped.
PlaceboDrug
Tongjiang granules placebo , Jianpi Qinghua granules placebo and Wenpi Qingwei granules placebo. The above three kinds of granulated placebo are respectively made of the simulation containing the low dose original prescription. Taking method is the same as Tongjiang series prescription.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Tongjiang granules are taken orally in liver-stomach depression-heat syndrome, Jianpi Qinghua granules are taken orally in spleen deficiency damp-heat syndrome, Wenpi Qingwei granules are taken orally in cold-heat complicated syndrome, one bag per time, 3 times a day and 1 hour after a meal. At the same time, it was combined with acid inhibitors to reduce the steps of withdrawal treatment: in the 1-2 weeks, acid inhibitor (PPI) was reduced from the dose before entering the group to half of the dose, once a day, before going to bed; in the 3-4 weeks, acid inhibitor was changed from PPI to famotidine tablets, 20mg each time, before going to bed; in the 5-6 weeks, all acid inhibitors were stopped. Receives: Drug: Tongjiang series prescription(Tongjiang granules, Jianpi Qinghua granules and Wenpi Qingwei granules); Drug: Acid inhibitors |
| Control group | Placebo comparator | Tongjiang placebo granules are taken orally by patients with liver-stomach depression-heat syndrome, Jianpi Qinghua placebo granules are taken orally by patients with spleen deficiency damp-heat syndrome, Wenpi Qingwei placebo granules are taken orally by patients with cold-heat complicated syndrome, 1 bag per time, 3 times a day and 1 hour after a meal. At the same time, it was combined with acid inhibitors to reduce the steps of withdrawal treatment: in the 1-2 weeks, acid inhibitor (PPI) was reduced from the dose before entering the group to half of the dose, once a day, before going to bed; in the 3-4 weeks, acid inhibitor was changed from PPI to famotidine tablets, 20mg each time, before going to bed; in the 5-6 weeks, all acid inhibitors were stopped. Receives: Drug: Acid inhibitors; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of visual analogue (VAS) scores of reflow, heartburn and other major symptoms
During the period of taking medicine, the patients recorded the reflow and heartburn attacks (attack times and duration) within 24 hours every day on the symptom diary card, and VAS scores were performed on the reflow and heartburn symptoms. The average score of each symptom in the past week was calculated. The decrease rate of symptom score ≥ 50% after weekly treatment was recorded as response, and the number of response weeks was more than 50% of the whole treatment period, which was considered effective.
Measured: 6 weeks during treatment period, 4 weeks during follow-up period
Discontinuation rate of acid inhibitors
Discontinuation rate of acid inhibitors = Number of drug discontinuation/ Total number of people in each group
Measured: 6 weeks of treatment
The change of recurrence rate of main symptoms in Nonerosive Reflux Disease
The recurrence rate of the main symptoms, such as heartburn and reflux, was evaluated respectively. The recurrence rate = Number of symptom recurrence / Number of drug discontinuation.
Measured: 6 weeks of treatment, 4 weeks during follow-up period
Secondary outcomes (6)
Changes in secondary symptom scores
Secondary symptoms such as non cardiogenic chest pain, epigastric pain, burning sensation of epigastrium, belching, cough, asthma and foreign body sensation in pharynx were recorded and scored. Symptom frequency: none: 0 point; < 1 day / week: 1 point; 1 day / week: 2 points; 2-3 days / week: 3 points; 4-5 days / week: 4 points; 6-7 days / week: 5 points. Symptom degree: the symptom is not obvious, requiring the doctor's warning: 1 point; the symptom is obvious, affecting daily life, occasionally taking medicine: 3 points; the symptom is very obvious, affecting daily life, requiring long-term taking medicine: 5 points; between 1 point and 3 points, 2 points; between 3 points and 5 points, 4 points.
Measured: 6 weeks during treatment period, 4 weeks during follow-up period
Changes of Traditional Chinese Medicine syndrome score
Before and after treatment and during follow-up, TCM syndrome scores were recorded. Symptoms are divided into four grades: asymptomatic; mild: mild, not affecting daily life; moderate: moderate, partially affecting daily life; severe: severe, affecting daily life, hard to stick to work. According to the weight of syndrome main and secondary symptoms, the main symptoms are 0 points, 2 points, 4 points and 6 points respectively, and the secondary symptoms are 0 points, 1 point, 2 points and 3 points respectively.
Measured: Baseline, 2 weeks, 4 weeks and 6 weeks during treatment period, 2 weeks and 4 weeks during follow-up period
Changes of Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) scale scores
The gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) scale score was evaluated before and after treatment and during follow-up. The scoring standard is the same as the international standard.
Measured: Baseline, 2 weeks, 4 weeks and 6 weeks during treatment period, 2 weeks and 4 weeks during follow-up period
The change of the score of chronic gastrointestinal disease patient reported outcome (PRO) scale
Before and after treatment and during the follow-up period, the chronic gastrointestinal disease patient reported outcome (PRO) scale score was evaluated. The scoring standard is the same as the international standard.
Measured: Baseline, 2 weeks, 4 weeks and 6 weeks during treatment period, 2 weeks and 4 weeks during follow-up period
The change of Self-rating anxiety scale (SAS) score
The anxiety was evaluated before and after treatment and during follow-up. The scoring standard is the same as the international standard.
Measured: Baseline, 2 weeks, 4 weeks and 6 weeks during treatment period, 2 weeks and 4 weeks during follow-up period
The change of Self-rating depression scale (SDS) score
The depression was evaluated before and after treatment and during follow-up. The scoring standard is the same as the international standard.
Measured: Baseline, 2 weeks, 4 weeks and 6 weeks during treatment period, 2 weeks and 4 weeks 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 posted9 Apr 2020
- Study start15 Jun 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Provincial Hospital of Traditional Chinese Medicine, Wuhan No.1 Hospital, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Kunshan Hospital of Traditional Chinese Medicine, Liuzhou 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
- NCT04340297
- Sponsor's protocol ID
- 2019YFC1709604
- Status last verified
- Jul 2020
- First submitted
- 1 Apr 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li X, Wu H, Zhang B, Chen T, Shi X, Ma J, Zhang J, Tang X, Wang F. Traditional Chinese medicine based on Tongjiang methodology combined with proton pump inhibitor (PPI) step-down in treating non-erosive reflux disease: a study protocol for a multicentered, randomized controlled clinical trial. Trials. 2022 Oct 18;23(1):879. doi: 10.1186/s13063-022-06811-x.
PubMed 36258217
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-Blind Clinical Trial of Tongjiang Theory and Syndrome Differentiation Serial Prescriptions Combined With Proton Pump Inhibitors(PPIs)Descending Ladder Withdrawal for the Treatment of Nonerosive Reflux Disease.
- ClinicalTrials.gov ID
- NCT04340297
- Acronym / sponsor ID
- 2019YFC1709604
- Conditions
- Nonerosive Reflux Disease
- Keywords
- Traditional Chinese medicine, Tongjiang series prescription, Randomized controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Guangdong Provincial Hospital of Traditional Chinese Medicine, Wuhan No.1 Hospital, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Kunshan Hospital of Traditional Chinese Medicine, Liuzhou Hospital of Traditional Chinese Medicine
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 9 Apr 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 preferred drug, have poor response, single target and poor acid inhibition effect in some patients in clinical application. Long-term use of PPI can lead to many side effects, even dependency. The main Traditional Chinese Medicine (TCM)syndrome types of NERD are liver-stomach depression-heat syndrome, spleen deficiency damp-heat syndrome and cold-heat complicated syndrome. TCM syndrome differentiation treatment has the advantages of overall regulation and individualized treatment. The purpose of this study is to evaluate the safety and efficacy advantages of syndrome differentiation series prescription combined with PPIs descending ladder withdrawal in the treatment of patients who use PPIs for a long time that can not stop, and to solve the problems of multiple side effects and dependency caused by long-term use of PPIs.
Detailed description
Nonerosive Reflux Disease (NERD) accounts for about 70% of Gastroesophageal Reflux Disease (GERD), which is a common refractory gastrointestinal disease. Proton Pump Inhibitors (PPIs), the preferred treatment, have the following problems in clinical use: about 50% of patients respond to PPIs only partially or not at all; PPIs has a single target, and the effect of acid suppression alone is poor; long term use of PPIs can lead to dyspepsia, fundic gland polyp, atrophic gastritis, intestinal flora disorders, and even dependency. Liver-stomach depression-heat syndrome, spleen deficiency damp-heat syndrome and cold-heat complicated syndrome account for 80%-91% of NERD's Traditional Chinese Medicine (TCM) syndrome. TCM syndrome differentiation treatment has the advantages of overall regulation and individualized treatment, but it lacks high-level evidence-based medicine evidence. On the basis of previous work, the project plans to establish sub centers in 6 Chinese hospitals, including 180 patients with NERD who meet the requirements to carry out a multicenter, randomized, double-blind, placebo-controlled clinical study, in which 90 subjects in the experimental group received the treatment of syndrome differentiation series of prescriptions combined with PPIs descending ladder withdrawal, and 90 subjects in the control group received the treatment of placebo combined with PPIs descending ladder withdrawal. 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. The purpose of this study is to evaluate the efficacy advantage and safety of Tongjiang series prescription combined with PPIs descending ladder withdrawal compared with PPIs descending ladder withdrawal alone for patients who use PPIs for a long time that can not stop, so as to obtain evidence-based medical evidence of high-quality TCM syndrome differentiation treatment of NERD, and form an effective and popularized treatment plan to solve the problems of various side effects and dependency caused by long-term use of PPIs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Tongjiang series prescription(Tongjiang granules, Jianpi Qinghua granules and Wenpi Qingwei granules), Drug: Acid inhibitorsTongjiang granules are taken orally in liver-stomach depression-heat syndrome, Jianpi Qinghua granules are taken orally in spleen deficiency damp-heat syndrome, Wenpi Qingwei granules are taken orally in cold-heat complicated syndrome, one bag per time, 3 times a day and 1 hour after a meal. At the same time, it was combined with acid inhibitors to reduce the steps of withdrawal treatment: in the 1-2 weeks, acid inhibitor (PPI) was reduced from the dose before entering the group to half of the dose, once a day, before going to bed; in the 3-4 weeks, acid inhibitor was changed from PPI to famotidine tablets, 20mg each time, before going to bed; in the 5-6 weeks, all acid inhibitors were stopped. |
| Control group | Placebo comparator | Drug: Acid inhibitors, Drug: PlaceboTongjiang placebo granules are taken orally by patients with liver-stomach depression-heat syndrome, Jianpi Qinghua placebo granules are taken orally by patients with spleen deficiency damp-heat syndrome, Wenpi Qingwei placebo granules are taken orally by patients with cold-heat complicated syndrome, 1 bag per time, 3 times a day and 1 hour after a meal. At the same time, it was combined with acid inhibitors to reduce the steps of withdrawal treatment: in the 1-2 weeks, acid inhibitor (PPI) was reduced from the dose before entering the group to half of the dose, once a day, before going to bed; in the 3-4 weeks, acid inhibitor was changed from PPI to famotidine tablets, 20mg each time, before going to bed; in the 5-6 weeks, all acid inhibitors were stopped. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. It meets the diagnostic criteria of nonerosive reflex disease(NERD)
- 2. Patients with PPIs who are effective for more than 8 weeks and relapse after discontinuation
- 3. Age between 18 and 70 years old
- 4. It meets the diagnostic criteria of liver-stomach depression-heat syndrome, spleen deficiency damp-heat syndrome and cold-heat complicated syndrome of traditional Chinese medicine
- 5. Patients have informed consent and are willing to receive corresponding treatment
Key exclusion criteria (7 listed)
- 1. Patients with active peptic ulcer, gastrointestinal hemorrhage, severe dysplasia of gastric mucosa or suspected malignant change, achalasia or postoperative achalasia
- 2. There are other 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
- 3. Patients with 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
- 4. Pregnant and lactating women
- 5. Patients with 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 |
|---|---|---|
| Tongjiang series prescription(Tongjiang granules, Jianpi Qinghua granules and Wenpi Qingwei granules)According to the syndrome differentiation of TCM, Tongjiang granules are taken orally by patients with liver-stomach depression-heat syndrome, Jianpi Qinghua granules are taken orally by patients with spleen deficiency damp-heat syndrome, Wenpi Qingwei granules are taken orally by patients with cold-heat complicated syndrome, 1 bag per time, 3 times a day and 1 hour after a meal. | Drug | Experimental group |
| Acid inhibitorsIn the 1-2 weeks, acid inhibitor (PPI) was reduced from the dose before entering the group to half of the dose, once a day, before going to bed; in the 3-4 weeks, acid inhibitor was changed from PPI to famotidine tablets, 20mg each time, before going to bed; in the 5-6 weeks, all acid inhibitors were stopped. | Drug | Control group, Experimental group |
| PlaceboTongjiang granules placebo , Jianpi Qinghua granules placebo and Wenpi Qingwei granules placebo. The above three kinds of granulated placebo are respectively made of the simulation containing the low dose original prescription. Taking method is the same as Tongjiang series prescription. | Drug | Control group |
Primary outcome
Changes of visual analogue (VAS) scores of reflow, heartburn and other major symptoms
Time frame: 6 weeks during treatment period, 4 weeks during follow-up period
During the period of taking medicine, the patients recorded the reflow and heartburn attacks (attack times and duration) within 24 hours every day on the symptom diary card, and VAS scores were performed on the reflow and heartburn symptoms. The average score of each symptom in the past week was calculated. The decrease rate of symptom score ≥ 50% after weekly treatment was recorded as response, and the number of response weeks was more than 50% of the whole treatment period, which was considered effective.
Discontinuation rate of acid inhibitors
Time frame: 6 weeks of treatment
Discontinuation rate of acid inhibitors = Number of drug discontinuation/ Total number of people in each group
The change of recurrence rate of main symptoms in Nonerosive Reflux Disease
Time frame: 6 weeks of treatment, 4 weeks during follow-up period
The recurrence rate of the main symptoms, such as heartburn and reflux, was evaluated respectively. The recurrence rate = Number of symptom recurrence / Number of drug discontinuation.
6 secondary outcomes
Changes in secondary symptom scores
Time frame: 6 weeks during treatment period, 4 weeks during follow-up period
Changes of Traditional Chinese Medicine syndrome score
Time frame: Baseline, 2 weeks, 4 weeks and 6 weeks during treatment period, 2 weeks and 4 weeks during follow-up period
Changes of Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) scale scores
Time frame: Baseline, 2 weeks, 4 weeks and 6 weeks during treatment period, 2 weeks and 4 weeks during follow-up period
The change of the score of chronic gastrointestinal disease patient reported outcome (PRO) scale
Time frame: Baseline, 2 weeks, 4 weeks and 6 weeks during treatment period, 2 weeks and 4 weeks during follow-up period
The change of Self-rating anxiety scale (SAS) score
Time frame: Baseline, 2 weeks, 4 weeks and 6 weeks during treatment period, 2 weeks and 4 weeks during follow-up period
The change of Self-rating depression scale (SDS) score
Time frame: Baseline, 2 weeks, 4 weeks and 6 weeks during treatment period, 2 weeks and 4 weeks 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 29 Jul 2020.
- Derived from this study: PubMed 36258217Li X, Wu H, Zhang B, Chen T, Shi X, Ma J, Zhang J, Tang X, Wang F. Traditional Chinese medicine based on Tongjiang methodology combined with proton pump inhibitor (PPI) step-down in treating non-erosive reflux disease: a study protocol for a multicentered, randomized controlled clinical trial. Trials. 2022 Oct 18;23(1):879. doi: 10.1186/s13063-022-06811-x.
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.
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 Phase 3 study testing Tongjiang series prescription(Tongjiang granules, Jianpi Qinghua granules and Wenpi Qingwei granules) and Acid inhibitors 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 29 Jul 2020. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yingpan Zhao, M.D. (+86(010)62835101, zypzyp1984@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of visual analogue (VAS) scores of reflow, heartburn and other major symptoms (time frame: 6 weeks during treatment period, 4 weeks during follow-up period). The study lists 3 primary outcomes in all. 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 NCT04340297, 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 29 Jul 2020.