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

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Treatments: Omeprazole

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