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Efficacy of Traditional Chinese Medicine Combined With Omeprazole in Patients With Non-erosive Reflux Disease

Primary Purpose

Non-erosive Reflux Disease

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Treatment group
Control group
Sponsored by
Xiyuan Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-erosive Reflux Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dongfang HospitalRecruiting
  • Guanganmen HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change of GERD Q Scale
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.

Secondary Outcome Measures

Change of TCM Syndrome Questionnaire
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.
Change of 36-Item Short Form Survey Instrument(SF-36)
SF-36 reflects healthy condition.
Change of Patients Report Clinical Outcomes(PRO)
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.
Change of the Hamilton Depression Scale 17 item (HAMD17)
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.
Safety outcomes
Safty indexs contain adverse event, general medical examination, blood biochemical examination, urine and stool routine test and electrocardiography.

Full Information

First Posted
September 2, 2016
Last Updated
August 20, 2019
Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02892357
Brief Title
Efficacy of Traditional Chinese Medicine Combined With Omeprazole in Patients With Non-erosive Reflux Disease
Official Title
Efficacy of Traditional Chinese Medicine Jianpi Qinghua Granule Combined With Low Dose Omeprazole in Patients With Non-erosive Reflux Disease (NERD)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-erosive Reflux Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Treatment group
Other Intervention Name(s)
Experimental group
Intervention Description
Jianpi Qinghua granules:twice a day,1 bag a time;10mg omeprazole and 10mg sham ,once a day,all for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Control group
Other Intervention Name(s)
Omeprazole group
Intervention Description
sham Jianpi Qinghua granules:twice a day,1 bag a time; 20mg omeprazole once a day ,all for 4 weeks.
Primary Outcome Measure Information:
Title
Change of GERD Q Scale
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change of TCM Syndrome Questionnaire
Description
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.
Time Frame
6 weeks
Title
Change of 36-Item Short Form Survey Instrument(SF-36)
Description
SF-36 reflects healthy condition.
Time Frame
6 weeks
Title
Change of Patients Report Clinical Outcomes(PRO)
Description
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.
Time Frame
6 weeks
Title
Change of the Hamilton Depression Scale 17 item (HAMD17)
Description
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.
Time Frame
6 weeks
Title
Safety outcomes
Description
Safty indexs contain adverse event, general medical examination, blood biochemical examination, urine and stool routine test and electrocardiography.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
fengyun Wang, Ph.D
Phone
+86-10-62835001
Email
wfy811@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fengyun Wang, Ph.D
Organizational Affiliation
xi yuan hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Dongfang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Zhang
Facility Name
Guanganmen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bing Zhou

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34119741
Citation
Zhang J, Che H, Zhang B, Zhang C, Zhou B, Ji H, Xie J, Shi X, Li X, Wang F, Tang X. JianpiQinghua granule reduced PPI dosage in patients with nonerosive reflux disease: A multicenter, randomized, double-blind, double-dummy, noninferiority study. Phytomedicine. 2021 Jul 15;88:153584. doi: 10.1016/j.phymed.2021.153584. Epub 2021 May 3.
Results Reference
derived

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Efficacy of Traditional Chinese Medicine Combined With Omeprazole in Patients With Non-erosive Reflux Disease

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