- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02892357
Efficacy of Traditional Chinese Medicine Combined With Omeprazole in Patients With Non-erosive Reflux Disease
August 20, 2019 updated by: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Efficacy of Traditional Chinese Medicine Jianpi Qinghua Granule Combined With Low Dose Omeprazole in Patients With Non-erosive Reflux Disease (NERD)
This is a double-blind,randomised,placebo-controlled clinical trial.We would like to investigate the safety and efficacy of Jianpi Qinghua granule(a Chinese herbal compound) combined with half-dose omeprazole in treatment of non-erosive reflux disease(NERD).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
This is a double-blind,randomised,placebo-controlled clinical trial.We recruit patients that suffer from non-erosive reflux disease and then divide them into two groups:treatment group and control group.Treatment group take Jianpi Qinghua granule and half-dose omeprazole for 4 weeks,control group take a normal dose of omeprazole for 4 weeks.Finally we investigate the safety of Jianpi Qinghua granule combined with half-dose omeprazole in treatment of non-erosive reflux disease(NERD),and contrast the efficacy of Jianpi Qinghua granule with omeprazole.
Study Type
Interventional
Enrollment (Anticipated)
204
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: fengyun Wang, Ph.D
- Phone Number: +86-10-62835001
- Email: wfy811@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100000
- Recruiting
- Dongfang Hospital
-
Contact:
- Chang Zhang
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Beijing, Beijing, China, 100000
- Recruiting
- Guanganmen Hospital
-
Contact:
- Bing Zhou
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aging between 18 and 75 years, able to read and write Chinese;
- Meet the criteria of diagnosis of NERD
- GERD Q score>=8
- Meet the TCM diagnosis of syndrome of dampness-heat due to spleen deficiency
- Receiving no other treatments during the study;
- Voluntarily agreeing with the study protocol and signing a written informed consent.
Exclusion Criteria:
- Gastro-duodenal ulcer
- Infections, inflammations, or obstruction of the small or large intestine
- History of gastrointestinal cancer, or prior surgery of the stomach or intestine
- Females who are pregnant or those lacking adequate contraception
- Unwilling to sign the informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment group
Participants in this group take the herbal compound of Jianpi Qinghua granules and half-dose omeprazole tablet.Jianpi Qinghua granule:one bag after 1 hour of breakfast and supper(twice a day) for 4 weeks.Half-dose omeprazole tablet:1 tablet of real omeprazole (10mg) and 1 tablet of Sham(10mg),once a day before breakfast for 4 weeks.
|
Jianpi Qinghua granules:twice a day,1 bag a time;10mg omeprazole and 10mg sham ,once a day,all for 4 weeks.
Other Names:
|
Active Comparator: Control group
Participants in this group take the sham herbal granules twice a day as treatment group and two pieces of real omeprazole tablet(10mg each) once a day before breakfast for 4 weeks.
|
sham Jianpi Qinghua granules:twice a day,1 bag a time; 20mg omeprazole once a day ,all for 4 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of GERD Q Scale
Time Frame: 6 weeks
|
GerdQ was developed through the integration of validated questionnaires reflecting psychological problems and the data of diagnoses of GERD in primary and secondary medical institutions.
GerdQ is used for the diagnosis and management of GERD with good authenticity and reliability.
GerdQ has six items: heartburn, regurgitation, abdominal pain, nausea, sleep disorders and use of OTC medications.
The score is evaluated according to the frequency of every item occurred in recent one week.
0 day, 1 day, 2-3 days, 4-7days respectively assessed to the score of 0, 1, 2 and 3 in the items of heartburn, regurgitation, sleep disorders and use of OTC medications.
0 day, 1 day, 2-3 days, 4-7days respectively assessed to the score of 3, 2, 1 and 0 in the items of abdominal pain and nausea.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of TCM Syndrome Questionnaire
Time Frame: 6 weeks
|
The scale is based on the Clinical Guideline of New Drugs for Traditional Chinese Medicine.
It is uesd to evaluate the discomfort of gastrointestinal system based on TCM theory.
It contains 15 items of TCM terminology which used to assess severity of physical discomfort (0 = absent; 1 = mild; 2 = moderate; 3 = severe).
The main concerns of these items include stomach distension, stomachache, appetite decrease, heartburn, acid regurgitation, sputum increase, feeling of obstruction in pharynx, feeling thirsty but not want water, feeling of distention on both sides of the lower abdomen, limbs weakness, short of breath, feeling weak and unwilling to speak, somatosensory heaviness, feeling afraid of the cold and having loose stool.
|
6 weeks
|
Change of 36-Item Short Form Survey Instrument(SF-36)
Time Frame: 6 weeks
|
SF-36 reflects healthy condition.
|
6 weeks
|
Change of Patients Report Clinical Outcomes(PRO)
Time Frame: 6 weeks
|
The PRO was developed by the digestive department of Xiyuan hospital.
Considering the clinical characteristics of patients with chronic gastrointestinal diseases in China, we have spended two years to collect measurement indicators, screen and optimizing items, implement pre-survey of small samples and field survey, and finally formulated this current PRO.
It contains 35 items in six dimensions (regurgitation, dyspepsia, physical status, ability to life, defecation situation and mental state).
Our analysis of 274 questionnaires show that the PRO has good reliability and validity in reflecting the situation of chronic gastrointestinal diseases.
Every item in PRO has five levels of discomfort(never, occasionally, sometimes, often, always) and they respectively represent the score of 0, 1, 2, 3 and 4.
|
6 weeks
|
Change of the Hamilton Depression Scale 17 item (HAMD17)
Time Frame: 6 weeks
|
The scoring criteria of the scale were :(0)none;(1)mild;(2)moderate;(3)severe;(4) extremely heavy.A few items use the 3-grade scoring method with 0-2 points, and the grading standard is :(0) none;(1) mild to moderate;(2) severely.
|
6 weeks
|
Safety outcomes
Time Frame: 6 weeks
|
Safty indexs contain adverse event, general medical examination, blood biochemical examination, urine and stool routine test and electrocardiography.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: fengyun Wang, Ph.D, xi yuan hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2017
Primary Completion (Anticipated)
September 1, 2019
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
September 2, 2016
First Submitted That Met QC Criteria
September 7, 2016
First Posted (Estimate)
September 8, 2016
Study Record Updates
Last Update Posted (Actual)
August 26, 2019
Last Update Submitted That Met QC Criteria
August 20, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Digestion-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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