Efficacy of Traditional Chinese Medicine Jianpi Qinghua Granule Combined With Low Dose Omeprazole in Patients With Non-erosive Reflux Disease (NERD)
Overview
- Phase
- Phase 1
- Intervention
- Treatment group
- Conditions
- Non-erosive Reflux Disease
- Sponsor
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Enrollment
- 204
- Locations
- 2
- Primary Endpoint
- Change of GERD Q Scale
- Last Updated
- 6 years ago
Overview
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.
Investigators
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
Arms & Interventions
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.
Intervention: Treatment group
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.
Intervention: Control group
Outcomes
Primary Outcomes
Change of GERD Q Scale
Time Frame: 6 weeks
GerdQ was developed through the integration of validated questionnaires reflecting psychological problems and the data of diagnoses of GERD in primary and secondary medical institutions. GerdQ is used for the diagnosis and management of GERD with good authenticity and reliability. GerdQ has six items: heartburn, regurgitation, abdominal pain, nausea, sleep disorders and use of OTC medications. The score is evaluated according to the frequency of every item occurred in recent one week. 0 day, 1 day, 2-3 days, 4-7days respectively assessed to the score of 0, 1, 2 and 3 in the items of heartburn, regurgitation, sleep disorders and use of OTC medications. 0 day, 1 day, 2-3 days, 4-7days respectively assessed to the score of 3, 2, 1 and 0 in the items of abdominal pain and nausea.
Secondary Outcomes
- Safety outcomes(6 weeks)
- Change of Patients Report Clinical Outcomes(PRO)(6 weeks)
- Change of 36-Item Short Form Survey Instrument(SF-36)(6 weeks)
- Change of TCM Syndrome Questionnaire(6 weeks)
- Change of the Hamilton Depression Scale 17 item (HAMD17)(6 weeks)