Efficacy of Traditional Chinese Medicine Combined With Omeprazole in Patients With Non-erosive Reflux Disease
1 other identifier
interventional
204
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2017
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2016
CompletedFirst Posted
Study publicly available on registry
September 8, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedAugust 26, 2019
February 1, 2019
2.7 years
September 2, 2016
August 20, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
6 weeks
Secondary Outcomes (5)
Change of TCM Syndrome Questionnaire
6 weeks
Change of 36-Item Short Form Survey Instrument(SF-36)
6 weeks
Change of Patients Report Clinical Outcomes(PRO)
6 weeks
Change of the Hamilton Depression Scale 17 item (HAMD17)
6 weeks
Safety outcomes
6 weeks
Study Arms (2)
Treatment group
EXPERIMENTALParticipants 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.
Control group
ACTIVE COMPARATORParticipants 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.
Interventions
Jianpi Qinghua granules:twice a day,1 bag a time;10mg omeprazole and 10mg sham ,once a day,all for 4 weeks.
sham Jianpi Qinghua granules:twice a day,1 bag a time; 20mg omeprazole once a day ,all for 4 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Dongfang Hospital
Beijing, Beijing Municipality, 100000, China
Guanganmen Hospital
Beijing, Beijing Municipality, 100000, China
Related Publications (1)
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.
PMID: 34119741DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
fengyun Wang, Ph.D
xi yuan hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2016
First Posted
September 8, 2016
Study Start
January 1, 2017
Primary Completion
September 1, 2019
Study Completion
December 1, 2019
Last Updated
August 26, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share