Non-erosive Reflux Disease/Diarrheal Irritable Bowel SyndromePhase 4NCT04454996
Study on the Rule and Mechanism of Treating Functional Gastrointestinal Diseases From the Perspective of Liver and Spleen
A Phase 4 study testing tong-jiang granules and Chang 'an II Recipe in people with Non-erosive Reflux Disease/Diarrheal Irritable Bowel Syndrome, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
To clarify the changes of intestinal flora - gut - brain axis in FGIDs patients represented by NERD disharmony of liver and stomach and IBS-D disharmony of liver and spleen, and confirm that the imbalance between intestinal flora and host co-metabolism is the key to the pathogenesis of functional gastrointestinal… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-erosive Reflux Disease/Diarrheal Irritable Bowel Syndrome
- What is being tested?
- tong-jiang granules and Chang 'an II Recipe
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2020to 30 Mar 2022
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers with no abnormal clinical manifestations;
- Meet the diagnostic criteria of NERD syndrome of disharmony of liver and stomach and IBS-D syndrome of liver depression and spleen deficiency.
- Aged between 18 and 70.
- Did not take antibiotics, steroids or other hormones, Chinese herbal preparations (including oral and intravenous administration), microecological preparations or probiotics such as yogurt for nearly a week;
- Subjects are informed and sign informed consent voluntarily;
- Have certain reading ability.
Who cannot join
- Patients with severe lesions of the heart, liver, kidney and other major organs, hematopoietic system, nervous system or mental diseases;
- Complicated with other organic diseases of the digestive system (such as peptic ulcer), or systemic diseases that affect the dynamics of the digestive tract (such as hyperthyroidism and diabetes);
- Ongoing or ongoing use of drugs that may affect gastrointestinal function (antidiarrals, antidepressants, anti-anxiety drugs, intestinal microflora regulation drugs, antibiotics, etc.);
- Those with a history of allergy to related drugs or severe food allergy used in the research.
- The body is colonized with metal medical devices. (6) Having a pregnancy plan within three months.
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiyuan Hospital of China Academy of Chinese Medical Science
Beijing, Beijing Municipality, 100091
lin lv, 18811782728, lushangshitou@qq.com
About this study
Official title: Major Achievements in Traditional Chinese Medicine Science and Technology Guidance Projects-Study on the Rule and Mechanism of Treating Functional Gastrointestinal Diseases
To clarify the changes of intestinal flora - gut - brain axis in FGIDs patients represented by NERD disharmony of liver and stomach and IBS-D disharmony of liver and spleen, and confirm that the imbalance between intestinal flora and host co-metabolism is the key to the pathogenesis of functional gastrointestinal disease. To reveal the common mechanism of regulating liver and spleen (stomach) in treating FGIDs dynamic disorder and visceral hypersensitivity by regulating intestinal flora - intestine - brain axis disorder.
- Being tested
- tong-jiang granules, Chang 'an II Recipe, The placebo of tong-jiang granules, The placebo of Chang 'an II Recipe
- 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.
tong-jiang granulesDrug
This is a kind of compound Chinese medicine granules, 1 bag each time, 3 times a day, treatment for 4 weeks.
Chang 'an II RecipeDrug
This is Chang 'an II Prescription granule, 1 bag each time, 3 times a day, treatment for 4 weeks.
The placebo of tong-jiang granulesDrug
This is a granule, containing 5% tongyu granule active drug,1 bag each time, 3 times a day, treatment for 4 weeks.
The placebo of Chang 'an II RecipeDrug
This is a granule containing 5% chang 'an II,1 bag each time, 3 times a day, treatment for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Non-erosive reflux disease test group | Experimental | Not described Receives: Drug: tong-jiang granules |
| Non-erosive reflux disease control group | Placebo comparator | Not described Receives: Drug: The placebo of tong-jiang granules |
| Diarrhea-type irritable bowel syndrome test group | Experimental | Not described Receives: Drug: Chang 'an II Recipe |
| Control group with diarrheal irritable bowel syndrome | Placebo comparator | Not described Receives: Drug: The placebo of Chang 'an II Recipe |
| Healthy control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in 7 point Likert scale scores
The score of patients on the degree of remission of gastroesophageal reflux disease symptoms (acid reflux and heartburn) (1 point for obvious improvement of symptoms, 2 points for improvement of symptoms, 3 points for slight improvement of symptoms, 4 points for no change, 5 points for slight aggravation of symptoms, 6 points for aggravation of symptoms, and 7 points for obvious aggravation of symptoms)
Measured: Baseline, 2 weeks and 4 weeks during treatment period,4 weeks , 8 weeks , 12 weeks and 16 weeks during follow-up period
Changes in irritable bowel syndrome symptom severity scale scores
Irritable bowel syndrome symptom severity scale scores were assessed before and after treatment and during follow-up. The scoring standard is the same as the international standard.
Measured: Baseline, 2 weeks and 4 weeks during treatment period,4 weeks , 8 weeks , 12 weeks and 16 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 posted2 Jul 2020
- Study start25 Jun 2020 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Mar 2022 (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 Disease/Diarrheal Irritable Bowel SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454996
- Sponsor's protocol ID
- ZZ13-ZD-02
- Status last verified
- Jun 2020
- First submitted
- 20 Jun 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Major Achievements in Traditional Chinese Medicine Science and Technology Guidance Projects-Study on the Rule and Mechanism of Treating Functional Gastrointestinal Diseases
- ClinicalTrials.gov ID
- NCT04454996
- Acronym / sponsor ID
- ZZ13-ZD-02
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 25 Jun 2020 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 2 Jul 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.
To clarify the changes of intestinal flora - gut - brain axis in FGIDs patients represented by NERD disharmony of liver and stomach and IBS-D disharmony of liver and spleen, and confirm that the imbalance between intestinal flora and host co-metabolism is the key to the pathogenesis of functional gastrointestinal disease. To reveal the common mechanism of regulating liver and spleen (stomach) in treating FGIDs dynamic disorder and visceral hypersensitivity by regulating intestinal flora - intestine - brain axis disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Non-erosive reflux disease test group | Experimental | Drug: tong-jiang granules |
| Non-erosive reflux disease control group | Placebo comparator | Drug: The placebo of tong-jiang granules |
| Diarrhea-type irritable bowel syndrome test group | Experimental | Drug: Chang 'an II Recipe |
| Control group with diarrheal irritable bowel syndrome | Placebo comparator | Drug: The placebo of Chang 'an II Recipe |
| Healthy control group | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy volunteers with no abnormal clinical manifestations;
- Meet the diagnostic criteria of NERD syndrome of disharmony of liver and stomach and IBS-D syndrome of liver depression and spleen deficiency.
- Aged between 18 and 70.
- Did not take antibiotics, steroids or other hormones, Chinese herbal preparations (including oral and intravenous administration), microecological preparations or probiotics such as yogurt for nearly a week;
- Subjects are informed and sign informed consent voluntarily;
Key exclusion criteria (6 listed)
- Patients with severe lesions of the heart, liver, kidney and other major organs, hematopoietic system, nervous system or mental diseases;
- Complicated with other organic diseases of the digestive system (such as peptic ulcer), or systemic diseases that affect the dynamics of the digestive tract (such as hyperthyroidism and diabetes);
- Ongoing or ongoing use of drugs that may affect gastrointestinal function (antidiarrals, antidepressants, anti-anxiety drugs, intestinal microflora regulation drugs, antibiotics, etc.);
- Those with a history of allergy to related drugs or severe food allergy used in the research.
- The body is colonized with metal medical devices. (6) Having a pregnancy plan within three months.
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 |
|---|---|---|
| tong-jiang granulesThis is a kind of compound Chinese medicine granules, 1 bag each time, 3 times a day, treatment for 4 weeks. | Drug | Non-erosive reflux disease test group |
| Chang 'an II RecipeThis is Chang 'an II Prescription granule, 1 bag each time, 3 times a day, treatment for 4 weeks. | Drug | Diarrhea-type irritable bowel syndrome test group |
| The placebo of tong-jiang granulesThis is a granule, containing 5% tongyu granule active drug,1 bag each time, 3 times a day, treatment for 4 weeks. | Drug | Non-erosive reflux disease control group |
| The placebo of Chang 'an II RecipeThis is a granule containing 5% chang 'an II,1 bag each time, 3 times a day, treatment for 4 weeks. | Drug | Control group with diarrheal irritable bowel syndrome |
Primary outcome
Changes in 7 point Likert scale scores
Time frame: Baseline, 2 weeks and 4 weeks during treatment period,4 weeks , 8 weeks , 12 weeks and 16 weeks during follow-up period
The score of patients on the degree of remission of gastroesophageal reflux disease symptoms (acid reflux and heartburn) (1 point for obvious improvement of symptoms, 2 points for improvement of symptoms, 3 points for slight improvement of symptoms, 4 points for no change, 5 points for slight aggravation of symptoms, 6 points for aggravation of symptoms, and 7 points for obvious aggravation of symptoms)
Changes in irritable bowel syndrome symptom severity scale scores
Time frame: Baseline, 2 weeks and 4 weeks during treatment period,4 weeks , 8 weeks , 12 weeks and 16 weeks during follow-up period
Irritable bowel syndrome symptom severity scale scores were assessed before and after treatment and during follow-up. The scoring standard is the same as the international standard.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
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 4 study testing tong-jiang granules and Chang 'an II Recipe in people with Non-erosive Reflux Disease/Diarrheal 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 6 inclusion and 6 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 2 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 lin lv (18811782728, lushangshitou@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in 7 point Likert scale scores (time frame: Baseline, 2 weeks and 4 weeks during treatment period,4 weeks , 8 weeks , 12 weeks and 16 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 2 Jul 2020.