Clinical trial NCT04324138: Efficacy and Safety of Jianpi Qinghua Granules in Patients With Nonerosive Reflux Disease
Official title: Efficacy and Safety of Jianpi Qinghua Granules in Patients With Nonerosive Reflux Disease:a Multicenter,Randomized, Double-blind, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Nonerosive Reflux Disease
Keywords: Nonerosive Reflux Disease
Traditional Chinese Medicine
Randomized placebo controlled trial
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Liaoning University of Traditional Chinese Medicine
name: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
First posted: 2020-03-27
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nonerosive reflux disease (NERD) is a common refractory gastrointestinal disease. Proton pump inhibitors (PPIs), the first choice drug, have the following problems in clinical use: about 50 % of patients have no response to PPIs; the efficacy of simple acid suppression is poor; long-term use of PPIs can lead to indigestion, gastric polyps, atrophic gastritis, intestinal dysbacteriosis. Spleen Deficiency and Damp-heat Syndrome is one of the common clinical syndrome of NERD.TCM syndrome differentiation and treatment has the advantages of overall regulation and individualized treatment, but lack of high-level evidence. The purpose of this study is to evaluate the efficacy and safety of Jianpi Qinghua Granules for treating NERD with spleen deficiency and damp heat syndrome.

Detailed description: Nonerosive reflux disease (NERD), representing about 70% of gastroesophageal reflux disease, is a common refractory gastrointestinal disease. Proton pump inhibitors (PPIs), the first choice drug, have the following problems in clinical use: about 50 % of patients have no response to PPIs; the efficacy of simple acid suppression is poor; long-term use of PPIs can lead to indigestion, gastric polyps, atrophic gastritis, intestinal dysbacteriosis. Spleen Deficiency and Damp-heat Syndrome is one of the common clinical syndrome of NERD.TCM syndrome differentiation and treatment has the advantages of overall regulation and individualized treatment, but lack of high-level evidence. NERD is the result of multifactorial pathogenicity. The reflux symptoms not only related to acid reflux, but also related to alkali, gas, mixed reflux, etc. The theory of Tongjiang put forward by Academician Dong Jianhua.Under the guidance of Academician Dong Jianhua, the research team create a prescription Jianpi Qinghua granule for treating NERD with spleen deficiency and damp-heat syndrome. The purpose of this study is to evaluate the efficacy and safety of Jianpi Qinghua Granules for treating NERD with spleen deficiency and damp heat syndrome based on a a multicenter,randomized, double-blind, placebo-controlled clinical trial.

On the basis of previous work, the project plans to establish sub centers in 3 Chinese hospitals, including78 patients with NERD and spleen deficiency and damp-heat syndrome. The therapeutic effects were evaluated from the following aspects: the VAS score of reflow and heartburn, the rate of discontinuation of antacids, the rate of recurrence of NERD symptoms, the score of TCM syndromes and the improvement of gastrointestinal function.

Eligibility criteria: Inclusion Criteria:

1. Subjects diagnosed with non-erosive reflux disease
2. Subjects who have a medical history of PPI with poor therapeutic effect
3. Subjects aged between 18 and 70 years
4. Subjects diagnosed with spleen deficiency damp-heat syndrome of traditional Chinese medicine
5. Subjects who voluntarily signed written informed consent form

Exclusion Criteria:

1. Subjects who have active peptic ulcer, gastrointestinal hemorrhage, severe dysplasia of gastric mucosa or suspected malignant change, achalasia or postoperative achalasia
2. Subjects who have organic diseases of the digestive system (such as acute and chronic pancreatitis, cirrhosis, etc.), or systemic diseases that affect the gastrointestinal motility, such as hyperthyroidism, diabetes mellitus over 10 years, chronic renal insufficiency, spirit (the score of SAS and SDS shows severe anxiety or depression), nervous system diseases, etc
3. Subjects who have severe organ diseases such as heart, liver and kidney (such as ALT, AST more than 2 times of normal value), hematopoietic system diseases and tumors
4. Pregnant or lactating women
5. Subjects who have a history of nervous system disease and mental disease
6. Subjects who have a history of allergies to all the test drugs
7. Subjects who are participating in other clinical trials or have participated in other clinical trials within 4 weeks

Primary outcomes:
measure: Change of visual analogue (VAS) score of reflux symptoms and heartburn
timeFrame: week 1, week 2，week 3, week 4 during treatment period, week 6 and week 8 during follow-up period
Secondary outcomes:
measure: Change of secondary symptom score
timeFrame: week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
measure: Change of traditional Chinese Medicine syndrome score
timeFrame: week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
measure: Change of gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) scale score
timeFrame: week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
measure: Change of patient ported outcome (PRO) for chronic gastrointestinal disease scale score
timeFrame: week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
measure: Change of self-rating anxiety scale (SAS) score
timeFrame: week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
measure: Change of self-rating depression scale (SDS) score
timeFrame: week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xiyuan Hospital
state: Beijing
Study officials:
affiliation: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: beihua zhang, M.D
role: STUDY_CHAIR
affiliation: Liaoning University of Traditional Chinese Medicine
name: guang bai, M.D
role: STUDY_DIRECTOR
affiliation: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
name: wei wang, M.M
role: STUDY_DIRECTOR
References: