Gastroesophageal RefluxPhase 1/2NCT05312463
Assessment on Effects of Tongjiang Granule in Treating Nonerosive Reflux Disease Overlapping Epigastric Pain Syndrome
A Phase 1/2 study testing Tongjiang granule and Tongjiang granule simulant in people with Gastroesophageal Reflux and Functional Dysphonia, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
Overlapping gastrointestinal symptoms of functional gastrointestinal diseases (FGIDs) is an internationally recognized problem in modern medical diagnosis and treatment. Such patients show more physical symptoms and worse quality of life, resulting in a huge economic burden. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroesophageal Reflux, Functional Dysphonia
- What is being tested?
- Tongjiang granule and Tongjiang granule simulant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2022to Oct 2024
- Phase
- Phase 1/2
- 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
- It meets the diagnostic criteria of nonerosive reflex disease(NERD)and epigastric pain syndrome(EPS)
- It meets the diagnostic criteria of liver-stomach depression-heat syndrome of traditional Chinese medicine
- Age between 18 and 70 years old
- Patients have informed consent and are willing to receive corresponding treatment
Who cannot join
- Patients with active peptic ulcer, gastrointestinal hemorrhage, severe dysplasia of gastric mucosa or suspected malignant change, achalasia or postoperative achalasia
- 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
- 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
- HP infection was positive (bacterial culture, histological examination, urea breath test, rapid urease test and fecal antigen test were positive);
- People with a history of gastric / abdominal surgery (excluding appendectomy);
- Pregnant and lactating women;
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- People with 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
- Other situations that reduce the possibility of enrollment or complicate enrollment according to the judgment of the researcher, such as frequent changes in working environment and other situations that are easy to cause loss of follow-up.
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
Fengyun Wang, professor, +86(010)62835610, wfy811@163.com
About this study
Official title: Randomized Double-Blind Clinical Trial of Tongjiang Granule in the Treatment of Patients With Overlapping Gastrointestinal Symptoms of Nonerosive Reflux Disease(NERD) and Epigastric Pain Syndrome(EPS)
Overlapping gastrointestinal symptoms of functional gastrointestinal diseases (FGIDs) is an internationally recognized problem in modern medical diagnosis and treatment. Such patients show more physical symptoms and worse quality of life, resulting in a huge economic burden. At present, FGIDs gastrointestinal symptoms overlap, lack of effective and systematic treatment, and the treatment goal is to improve symptoms.The study plans to carry out a multi center and large sample RCT clinical study of Tongjiang granule in the treatment of overlapping gastrointestinal symptoms of non erosive reflux disease(NERD)and epigastric pain syndrome（EPS, so as to provide high-level evidence-based evidence for the treatment of overlapping symptoms of FGIDs and form a diagnosis and treatment scheme that can be popularized.
Read the detailed description
Overlapping gastrointestinal symptoms of functional gastrointestinal diseases (FGIDs) is an internationally recognized modern medical treatment problem. More than 40.7% of people worldwide suffer from more than one FGIDs.Gastroesophageal reflux disease (GERD) and functional dyspepsia (FD) are common FGIDs. Clinically, the symptom overlap between GERD and FD is very common. Some studies show that 31.32% of FD and 41.15% of FD overlap GERD overlaps with FD, and the presence of FD reduces the response of GERD patients to proton pump inhibitors (PPIs).At present, the pathogenesis of gastrointestinal symptoms overlap in FGIDs is not clear, and there is a lack of effective and systematic treatment. Non erosive reflux disease (NERD) and epigastric pain syndrome (EPS) are common subtypes of GERD and FD. Nerd accounts for about 70% of GERD patients and EPS accounts for more than 50% of FD patients. Long-term use of PPI can lead to many side effects, even dependency. The treatment of traditional Chinese medicine compound has the characteristics of individualized syndrome differentiation and the advantage of "treating different diseases at the same time". It has a significant effect on the overlap of gastrointestinal symptoms in clinic.
- Conditions
- Gastroesophageal Reflux, Functional Dysphonia
- Being tested
- Tongjiang granule, Tongjiang granule simulant
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongjiang granuleDrug
Tongjiang granules, 1 bag / time, 3 times / day.
Tongjiang granule simulantDrug
Tongjiang granule simulant,1 bag / time, 3 times / day.
| Study group | Role | What they receive |
|---|---|---|
| Tongjiang granule group | Experimental | Experiment group: oral administration of Tongjiang granule with warm water after meal for 1 bag each time for three times a day. The medication period was 4 weeks. Receives: Drug: Tongjiang granule |
| Tongjiang granule simulant group | Placebo comparator | Control group:oral administration of Tongjiang granule simulant with warm water after meal for 1 bag each time for three times a day. The medication period was 4 weeks. Receives: Drug: Tongjiang granule simulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale（VAS）scores of main symptoms （heartburn, reflux, epigastric pain, epigastric burning sensation）
Observe the changes of VAS scores of main symptoms（heartburn, reflux, epigastric pain, epigastric burning sensation） at baseline and after 2, 4 weeks of medication and 2, 4 and 6 weeks of withdrawal，If the score descends, it indicates that the patient's condition has improved.
Measured: 10 weeks
Secondary outcomes (5)
Visual Analogue Scale（VAS）scores of Atypical symptoms and other symptom scores （chest pain, pharyngeal foreign body sensation, cough, etc）
Observe the changes of VAS scores of Atypical symptoms and other symptom scores（chest pain, pharyngeal foreign body sensation, cough, etc） at baseline and after 2, 4 weeks of medication and 2, 4 and 6 weeks of withdrawal,If the score descends, it indicates that the patient's condition has improved.
Measured: 10 weeks
the MOS item short from health survey (SF-36 scale)
Observe the changes of SF-36 scale at baseline and after 2, 4 weeks of medication and 2, 4 and 6 weeks of withdrawal,if the score descends, it indicates that the patient's condition has improved.
Measured: 10 weeks
Patient-Reported Outcome (Pro scale)
Observe the changes of Pro scale at baseline and after 2, 4 weeks of medication and 2, 4 and 6 weeks of withdrawal,if the score descends, it indicates that the patient's condition has improved.
Measured: 10 weeks
Hospital Anxiety and Depression Scale (HAD)
Observe the changes of Hospital Anxiety and Depression Scale (had) at baseline and after 2, 4 weeks of medication and 2, 4 and 6 weeks of withdrawal,if the score descends, it indicates that the patient's condition has improved.
Measured: 10 weeks
Visceral Sensitivity Scale (VSI)
Observe the changes of Visceral Sensitivity Scale (VSI) at baseline and after 2, 4 weeks of medication and 2, 4 and 6 weeks of withdrawal,if the score descends, it indicates that the patient's condition has improved.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start26 Mar 2022
- Primary completionOct 2023 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Heilongjiang Chinese Medicine University, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Liuzhou Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312463
- Sponsor's protocol ID
- 2021XLA117-3
- Status last verified
- Apr 2022
- First submitted
- 3 Mar 2022
- Last updated
- 5 Apr 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 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-Blind Clinical Trial of Tongjiang Granule in the Treatment of Patients With Overlapping Gastrointestinal Symptoms of Nonerosive Reflux Disease(NERD) and Epigastric Pain Syndrome(EPS)
- ClinicalTrials.gov ID
- NCT05312463
- Acronym / sponsor ID
- 2021XLA117-3
- Conditions
- Gastroesophageal Reflux, Functional Dysphonia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Heilongjiang Chinese Medicine University, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Liuzhou Hospital of Traditional Chinese Medicine
- Study start
- 26 Mar 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 5 Apr 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.
Overlapping gastrointestinal symptoms of functional gastrointestinal diseases (FGIDs) is an internationally recognized problem in modern medical diagnosis and treatment. Such patients show more physical symptoms and worse quality of life, resulting in a huge economic burden. At present, FGIDs gastrointestinal symptoms overlap, lack of effective and systematic treatment, and the treatment goal is to improve symptoms.The study plans to carry out a multi center and large sample RCT clinical study of Tongjiang granule in the treatment of overlapping gastrointestinal symptoms of non erosive reflux disease(NERD)and epigastric pain syndrome（EPS, so as to provide high-level evidence-based evidence for the treatment of overlapping symptoms of FGIDs and form a diagnosis and treatment scheme that can be popularized.
Detailed description
Overlapping gastrointestinal symptoms of functional gastrointestinal diseases (FGIDs) is an internationally recognized modern medical treatment problem. More than 40.7% of people worldwide suffer from more than one FGIDs.Gastroesophageal reflux disease (GERD) and functional dyspepsia (FD) are common FGIDs. Clinically, the symptom overlap between GERD and FD is very common. Some studies show that 31.32% of FD and 41.15% of FD overlap GERD overlaps with FD, and the presence of FD reduces the response of GERD patients to proton pump inhibitors (PPIs).At present, the pathogenesis of gastrointestinal symptoms overlap in FGIDs is not clear, and there is a lack of effective and systematic treatment. Non erosive reflux disease (NERD) and epigastric pain syndrome (EPS) are common subtypes of GERD and FD. Nerd accounts for about 70% of GERD patients and EPS accounts for more than 50% of FD patients. Long-term use of PPI can lead to many side effects, even dependency. The treatment of traditional Chinese medicine compound has the characteristics of individualized syndrome differentiation and the advantage of "treating different diseases at the same time". It has a significant effect on the overlap of gastrointestinal symptoms in clinic.
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 |
|---|---|---|
| Tongjiang granule group | Experimental | Drug: Tongjiang granuleExperiment group: oral administration of Tongjiang granule with warm water after meal for 1 bag each time for three times a day. The medication period was 4 weeks. |
| Tongjiang granule simulant group | Placebo comparator | Drug: Tongjiang granule simulantControl group:oral administration of Tongjiang granule simulant with warm water after meal for 1 bag each time for three times a day. 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)
- It meets the diagnostic criteria of nonerosive reflex disease(NERD)and epigastric pain syndrome(EPS)
- It meets the diagnostic criteria of liver-stomach depression-heat syndrome of traditional Chinese medicine
- Age between 18 and 70 years old
- Patients have informed consent and are willing to receive corresponding treatment
Key exclusion criteria (9 listed)
- Patients with active peptic ulcer, gastrointestinal hemorrhage, severe dysplasia of gastric mucosa or suspected malignant change, achalasia or postoperative achalasia
- 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
- 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
- HP infection was positive (bacterial culture, histological examination, urea breath test, rapid urease test and fecal antigen test were positive);
- People with a history of gastric / abdominal surgery (excluding appendectomy);
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 granuleTongjiang granules, 1 bag / time, 3 times / day. | Drug | Tongjiang granule group |
| Tongjiang granule simulantTongjiang granule simulant,1 bag / time, 3 times / day. | Drug | Tongjiang granule simulant group |
Primary outcome
Visual Analogue Scale（VAS）scores of main symptoms （heartburn, reflux, epigastric pain, epigastric burning sensation）
Time frame: 10 weeks
Observe the changes of VAS scores of main symptoms（heartburn, reflux, epigastric pain, epigastric burning sensation） at baseline and after 2, 4 weeks of medication and 2, 4 and 6 weeks of withdrawal，If the score descends, it indicates that the patient's condition has improved.
5 secondary outcomes
Visual Analogue Scale（VAS）scores of Atypical symptoms and other symptom scores （chest pain, pharyngeal foreign body sensation, cough, etc）
Time frame: 10 weeks
the MOS item short from health survey (SF-36 scale)
Time frame: 10 weeks
Patient-Reported Outcome (Pro scale)
Time frame: 10 weeks
Hospital Anxiety and Depression Scale (HAD)
Time frame: 10 weeks
Visceral Sensitivity Scale (VSI)
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tongjiang granule and Tongjiang granule simulant in people with Gastroesophageal Reflux and Functional Dysphonia, 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 9 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 5 Apr 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Fengyun Wang, professor (010-62835610, wfy811@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale（VAS）scores of main symptoms （heartburn, reflux, epigastric pain, epigastric burning sensation） (time frame: 10 weeks). 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 5 Apr 2022.