Non erosive reflux disease
Conditions
Interventions
Placebo group:Placebo group: Huoxue Tongjiang Granule Simulator, mainly composed of dextrin, 1 bag per time, once in the morning and once in the evening. Before taking, the granules were fully dissolv
Traditional Chinese Medicine Group:Traditional Chinese Medicine Group: Huoxue Tongjiang Formula Granules, 1 bag each time, once in the morning and once in the evening. Before taking, dissolve the gran
Sponsors
Tianjin Integrated Traditional Chinese and Western Medicine Hospital (Tianjin Nankai Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Confirmed non erosive reflux disease, meeting the diagnostic criteria of Western medicine; (2) Age range from 18 to 65 years old (including boundary values), regardless of gender; (3) Meets the diagnostic criteria for traditional Chinese medicine Qi stagnation and blood stasis syndrome; (4) The weekly average VAS score for reflux or heartburn is = 3.0; (5) Gastroesophageal reflux disease questionnaire (Gerd Q) score = 8 points; (6) Patient's informed consent and willingness to receive corresponding treatment
Exclusion criteria
Exclusion criteria: (1) Within the past year, gastroscopy suggests a diagnosis of reflux esophagitis or other serious esophageal complications, such as esophageal ulcers, hiatal hernia, Barrett's esophagus, early esophageal cancer, or esophageal cancer; (2) Previous surgeries that may affect esophageal or gastric function or gastric acid secretion; Or during the research period, plan to undergo surgical procedures that may affect esophageal and gastric motility, as well as gastric acid secretion, such as abdominal surgery and vagotomy; (3) Individuals with rheumatic and immune diseases that may have previously affected esophageal motility, such as scleroderma and Behcet's disease; Individuals with a history of esophageal radiation therapy or esophageal cryotherapy; (4) Individuals who have previously been diagnosed with organic diseases of the digestive system, such as achalasia, Zhuo Ai syndrome, inflammatory bowel disease, intestinal tuberculosis, intestinal ulcers, acute and chronic pancreatitis, liver cirrhosis, gallbladder stones with acute cholecystitis, other digestive system tumors, or those who have developed peptic ulcers in the past three months; (5) 13C breath test before random enrollment indicates current infection of Helicobacter pylori; (6) Other people who have been diagnosed with systemic diseases that affect the function of the digestive tract, such as hyperthyroidism or hypothyroidism, chronic renal insufficiency, autoimmune diseases, diabetes, etc; (7) Individuals with a history of severe diseases in the heart, brain, liver, kidney, immune, hematopoietic systems, as well as tumors, neurological or psychiatric disorders (such as severe depression/anxiety/bipolar disorder); (8) During the experiment, concomitant medications that affect gastrointestinal motility and function, such as acid suppressants, antacids, prokinetic drugs, anticholinergics, calcium channel blockers (excluding antihypertensive drugs), 5-HT3 receptor antagonists, antidepressants, anti anxiety drugs, etc., cannot be discontinued; (9) Individuals taking prohibited medications during the import period; (10) Pregnant or lactating women, patients who have a fertility plan within one month after enrollment and the end of the trial; (11) Individuals who are allergic to the investigational drug and its components; (12) Those who suspect or have a history of alcohol or drug abuse; (13) Patients who have participated in other clinical trials within the first month prior to enrollment; (14) Researchers believe that other individuals who are not suitable for clinical trials, such as those with severe conditions requiring emergency treatment, or those with insufficient compliance to complete this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The overall clinical symptom relief rate of NERD after 2 weeks of treatment, 4 weeks of treatment, and 2 weeks of follow-up by researchers;The effective rate of NERD after 2 weeks of treatment, 4 weeks of treatment, and 2 weeks of follow-up; | — |
Secondary
| Measure | Time frame |
|---|---|
| The improvement rate of the frequency and severity of single symptoms (heartburn, reflux) of NERD after 2 weeks of treatment, 4 weeks of treatment, and 2 weeks of follow-up by researchers after treatment;Researcher Gerd Q Scale Evaluation;Evaluation of Traditional Chinese Medicine Syndrome Points by Researchers; | — |
Countries
China
Contacts
Public Contactyanping tang
Tianjin Integrated Traditional Chinese and Western Medicine Hospital (Tianjin Nankai Hospital)
Outcome results
None listed