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

Non-erosive Reflux Disease Clinical Trial

Official title:

Efficacy of Traditional Chinese Medicine Jianpi Qinghua Granule Combined With Low Dose Omeprazole in Patients With Non-erosive Reflux Disease (NERD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02892357
• Other study ID #: Digestion-04
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 2017
• Est. completion date: December 2019

Study information

• Verified date: February 2019
• Source: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Contact: fengyun Wang, Ph.D
• Phone: +86-10-62835001
• Email: wfy811[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: December 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Non-erosive Reflux Disease

Intervention

Drug:
• Treatment group
Jianpi Qinghua granules:twice a day,1 bag a time;10mg omeprazole and 10mg sham ,once a day,all for 4 weeks.
• Control group
sham Jianpi Qinghua granules:twice a day,1 bag a time; 20mg omeprazole once a day ,all for 4 weeks.

Locations

Country	Name	City	State
China	Dongfang Hospital	Beijing	Beijing
China	Guanganmen Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xiyuan Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of GERD Q Scale	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.	6 weeks
Secondary	Change of TCM Syndrome Questionnaire	The scale is based on the Clinical Guideline of New Drugs for Traditional Chinese Medicine. It is uesd to evaluate the discomfort of gastrointestinal system based on TCM theory. It contains 15 items of TCM terminology which used to assess severity of physical discomfort (0 = absent; 1 = mild; 2 = moderate; 3 = severe). The main concerns of these items include stomach distension, stomachache, appetite decrease, heartburn, acid regurgitation, sputum increase, feeling of obstruction in pharynx, feeling thirsty but not want water, feeling of distention on both sides of the lower abdomen, limbs weakness, short of breath, feeling weak and unwilling to speak, somatosensory heaviness, feeling afraid of the cold and having loose stool.	6 weeks
Secondary	Change of 36-Item Short Form Survey Instrument(SF-36)	SF-36 reflects healthy condition.	6 weeks
Secondary	Change of Patients Report Clinical Outcomes(PRO)	The PRO was developed by the digestive department of Xiyuan hospital. Considering the clinical characteristics of patients with chronic gastrointestinal diseases in China, we have spended two years to collect measurement indicators, screen and optimizing items, implement pre-survey of small samples and field survey, and finally formulated this current PRO. It contains 35 items in six dimensions (regurgitation, dyspepsia, physical status, ability to life, defecation situation and mental state). Our analysis of 274 questionnaires show that the PRO has good reliability and validity in reflecting the situation of chronic gastrointestinal diseases. Every item in PRO has five levels of discomfort(never, occasionally, sometimes, often, always) and they respectively represent the score of 0, 1, 2, 3 and 4.	6 weeks
Secondary	Change of the Hamilton Depression Scale 17 item (HAMD17)	The scoring criteria of the scale were :(0)none;(1)mild;(2)moderate;(3)severe;(4) extremely heavy.A few items use the 3-grade scoring method with 0-2 points, and the grading standard is :(0) none;(1) mild to moderate;(2) severely.	6 weeks
Secondary	Safety outcomes	Safty indexs contain adverse event, general medical examination, blood biochemical examination, urine and stool routine test and electrocardiography.	6 weeks