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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Non-erosive Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Treatment group

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.

Group Type EXPERIMENTAL

Treatment group

Intervention Type DRUG

Jianpi Qinghua granules:twice a day,1 bag a time;10mg omeprazole and 10mg sham ,once a day,all for 4 weeks.

Control group

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.

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type DRUG

sham Jianpi Qinghua granules:twice a day,1 bag a time; 20mg omeprazole once a day ,all for 4 weeks.

Interventions

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Treatment group

Jianpi Qinghua granules:twice a day,1 bag a time;10mg omeprazole and 10mg sham ,once a day,all for 4 weeks.

Intervention Type DRUG

Control group

sham Jianpi Qinghua granules:twice a day,1 bag a time; 20mg omeprazole once a day ,all for 4 weeks.

Intervention Type DRUG

Other Intervention Names

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Experimental group Omeprazole group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No