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

Phase 1/2 Unknown 204 enrolled Xiyuan Hospital of China Academy of Chinese Medical Sciences

RandomizedParallel-groupTriple-blindTreatment

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).

Timeline

Start: 2017-01
Primary completion: 2019-09
Completion: 2019-12

Outcome

Mixed primary results

paper The primary endpoints were the rate of sufficient relief and complete resolution of GERD Q at week 4. PMID 34119741 ↗

paper Complete resolution was observed in 40.8% of patients in the combination group and 26.8% of patients in the PPI group after 4 weeks PMID 34119741 ↗

paper p = 0.039 PMID 34119741 ↗

paper Sufficient relief was observed in 50% of patients in the combination group and 43.30% of patients in the PPI group after 4 weeks PMID 34119741 ↗

paper p = 0.35 PMID 34119741 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Jianpi Qinghua granules	Traditional medicine (herbal / TCM)	34.8 g	Oral
Subject	Omeprazole	Other / unclassified	10 mg	Oral
Subject	Omeprazole	Other / unclassified	20 mg	Oral