Clinical trial NCT02892357: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Non-erosive Reflux Disease
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of GERD Q Scale
timeFrame: 6 weeks
Secondary outcomes:
measure: Change of TCM Syndrome Questionnaire
timeFrame: 6 weeks
measure: Change of 36-Item Short Form Survey Instrument(SF-36)
timeFrame: 6 weeks
measure: Change of Patients Report Clinical Outcomes(PRO)
timeFrame: 6 weeks
measure: Change of the Hamilton Depression Scale 17 item (HAMD17)
timeFrame: 6 weeks
measure: Safety outcomes
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongfang Hospital
state: Beijing
city: Beijing
country: China
facility: Guanganmen Hospital
state: Beijing
Study officials:
affiliation: xi yuan hospital
name: fengyun Wang, Ph.D
role: STUDY_CHAIR
References:
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.