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

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Non-erosive Reflux Disease

Treatments: Drug: Control group; Drug: Treatment group

Study type: Interventional

Funder types: Other

Identifiers

NCT02892357

Digestion-04

Details and patient eligibility

About

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).

Full 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.

Enrollment: 204 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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204 participants in 2 patient groups

Treatment group

Experimental group

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.

Treatment:

Drug: Treatment group

Control group

Active Comparator group

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.

Treatment:

Drug: Control group