Assessment on Effects of Tongjiang Granule in Treating Nonerosive Reflux Disease Overlapping Epigastric Pain Syndrome
Randomized Double-Blind Clinical Trial of Tongjiang Granule in the Treatment of Patients With Overlapping Gastrointestinal Symptoms of Nonerosive Reflux Disease(NERD) and Epigastric Pain Syndrome(EPS)
1 other identifier
interventional
228
1 country
1
Brief Summary
Overlapping gastrointestinal symptoms of functional gastrointestinal diseases (FGIDs) is an internationally recognized problem in modern medical diagnosis and treatment. Such patients show more physical symptoms and worse quality of life, resulting in a huge economic burden. At present, FGIDs gastrointestinal symptoms overlap, lack of effective and systematic treatment, and the treatment goal is to improve symptoms.The study plans to carry out a multi center and large sample RCT clinical study of Tongjiang granule in the treatment of overlapping gastrointestinal symptoms of non erosive reflux disease(NERD)and epigastric pain syndrome（EPS, so as to provide high-level evidence-based evidence for the treatment of overlapping symptoms of FGIDs and form a diagnosis and treatment scheme that can be popularized.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2022
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2022
CompletedStudy Start
First participant enrolled
March 26, 2022
CompletedFirst Posted
Study publicly available on registry
April 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedApril 5, 2022
April 1, 2022
1.5 years
March 3, 2022
April 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Visual Analogue Scale（VAS）scores of main symptoms （heartburn, reflux, epigastric pain, epigastric burning sensation）
Observe the changes of VAS scores of main symptoms（heartburn, reflux, epigastric pain, epigastric burning sensation） at baseline and after 2, 4 weeks of medication and 2, 4 and 6 weeks of withdrawal，If the score descends, it indicates that the patient's condition has improved.
10 weeks
Secondary Outcomes (5)
Visual Analogue Scale（VAS）scores of Atypical symptoms and other symptom scores （chest pain, pharyngeal foreign body sensation, cough, etc）
10 weeks
the MOS item short from health survey (SF-36 scale)
10 weeks
Patient-Reported Outcome (Pro scale)
10 weeks
Hospital Anxiety and Depression Scale (HAD)
10 weeks
Visceral Sensitivity Scale (VSI)
10 weeks
Study Arms (2)
Tongjiang granule group
EXPERIMENTALExperiment group: oral administration of Tongjiang granule with warm water after meal for 1 bag each time for three times a day. The medication period was 4 weeks.
Tongjiang granule simulant group
PLACEBO COMPARATORControl group:oral administration of Tongjiang granule simulant with warm water after meal for 1 bag each time for three times a day. The medication period was 4 weeks.
Interventions
Tongjiang granule simulant,1 bag / time, 3 times / day.
Eligibility Criteria
You may qualify if:
- It meets the diagnostic criteria of nonerosive reflex disease(NERD)and epigastric pain syndrome(EPS)
- It meets the diagnostic criteria of liver-stomach depression-heat syndrome of traditional Chinese medicine
- Age between 18 and 70 years old
- Patients have informed consent and are willing to receive corresponding treatment
You may not qualify if:
- Patients with active peptic ulcer, gastrointestinal hemorrhage, severe dysplasia of gastric mucosa or suspected malignant change, achalasia or postoperative achalasia
- There are other 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
- Patients with 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
- HP infection was positive (bacterial culture, histological examination, urea breath test, rapid urease test and fecal antigen test were positive);
- People with a history of gastric / abdominal surgery (excluding appendectomy);
- Pregnant and lactating women;
- People with a history of allergies to all the test drugs
- Subjects who are participating in other clinical trials or have participated in other clinical trials within 4 weeks
- Other situations that reduce the possibility of enrollment or complicate enrollment according to the judgment of the researcher, such as frequent changes in working environment and other situations that are easy to cause loss of follow-up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100091, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2022
First Posted
April 5, 2022
Study Start
March 26, 2022
Primary Completion
October 1, 2023
Study Completion
October 1, 2024
Last Updated
April 5, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share