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Assessment on Effects of Tongjiang Granule in Treating Nonerosive Reflux Disease Overlapping Epigastric Pain Syndrome

Primary Purpose

Gastroesophageal Reflux, Functional Dysphonia

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Tongjiang granule
Tongjiang granule simulant
Sponsored by
Xiyuan Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. It meets the diagnostic criteria of nonerosive reflex disease(NERD)and epigastric pain syndrome(EPS)
  2. It meets the diagnostic criteria of liver-stomach depression-heat syndrome of traditional Chinese medicine
  3. Age between 18 and 70 years old
  4. Patients have informed consent and are willing to receive corresponding treatment

Exclusion Criteria:

  1. Patients with active peptic ulcer, gastrointestinal hemorrhage, severe dysplasia of gastric mucosa or suspected malignant change, achalasia or postoperative achalasia
  2. 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
  3. 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
  4. HP infection was positive (bacterial culture, histological examination, urea breath test, rapid urease test and fecal antigen test were positive);
  5. People with a history of gastric / abdominal surgery (excluding appendectomy);
  6. Pregnant and lactating women;
  7. People with a history of allergies to all the test drugs
  8. Subjects who are participating in other clinical trials or have participated in other clinical trials within 4 weeks
  9. 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.

Sites / Locations

  • Xiyuan Hospital of China Academy of Chinese Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tongjiang granule group

Tongjiang granule simulant group

Arm Description

Experiment 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.

Control 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Visual Analogue Scale(VAS)scores of Atypical symptoms and other symptom scores (chest pain, pharyngeal foreign body sensation, cough, etc)
Observe the changes of VAS scores of Atypical symptoms and other symptom scores(chest pain, pharyngeal foreign body sensation, cough, etc) 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.
the MOS item short from health survey (SF-36 scale)
Observe the changes of SF-36 scale 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.
Patient-Reported Outcome (Pro scale)
Observe the changes of Pro scale 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.
Hospital Anxiety and Depression Scale (HAD)
Observe the changes of Hospital Anxiety and Depression Scale (had) 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.
Visceral Sensitivity Scale (VSI)
Observe the changes of Visceral Sensitivity Scale (VSI) 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.

Full Information

First Posted
March 3, 2022
Last Updated
April 1, 2022
Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Collaborators
First Affiliated Hospital of Heilongjiang Chinese Medicine University, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Liuzhou Hospital of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05312463
Brief Title
Assessment on Effects of Tongjiang Granule in Treating Nonerosive Reflux Disease Overlapping Epigastric Pain Syndrome
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 26, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Collaborators
First Affiliated Hospital of Heilongjiang Chinese Medicine University, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Liuzhou Hospital of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Overlapping gastrointestinal symptoms of functional gastrointestinal diseases (FGIDs) is an internationally recognized modern medical treatment problem. More than 40.7% of people worldwide suffer from more than one FGIDs.Gastroesophageal reflux disease (GERD) and functional dyspepsia (FD) are common FGIDs. Clinically, the symptom overlap between GERD and FD is very common. Some studies show that 31.32% of FD and 41.15% of FD overlap GERD overlaps with FD, and the presence of FD reduces the response of GERD patients to proton pump inhibitors (PPIs).At present, the pathogenesis of gastrointestinal symptoms overlap in FGIDs is not clear, and there is a lack of effective and systematic treatment. Non erosive reflux disease (NERD) and epigastric pain syndrome (EPS) are common subtypes of GERD and FD. Nerd accounts for about 70% of GERD patients and EPS accounts for more than 50% of FD patients. Long-term use of PPI can lead to many side effects, even dependency. The treatment of traditional Chinese medicine compound has the characteristics of individualized syndrome differentiation and the advantage of "treating different diseases at the same time". It has a significant effect on the overlap of gastrointestinal symptoms in clinic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux, Functional Dysphonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
228 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tongjiang granule group
Arm Type
Experimental
Arm Description
Experiment 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.
Arm Title
Tongjiang granule simulant group
Arm Type
Placebo Comparator
Arm Description
Control 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.
Intervention Type
Drug
Intervention Name(s)
Tongjiang granule
Intervention Description
Tongjiang granules, 1 bag / time, 3 times / day.
Intervention Type
Drug
Intervention Name(s)
Tongjiang granule simulant
Intervention Description
Tongjiang granule simulant,1 bag / time, 3 times / day.
Primary Outcome Measure Information:
Title
Visual Analogue Scale(VAS)scores of main symptoms (heartburn, reflux, epigastric pain, epigastric burning sensation)
Description
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.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Visual Analogue Scale(VAS)scores of Atypical symptoms and other symptom scores (chest pain, pharyngeal foreign body sensation, cough, etc)
Description
Observe the changes of VAS scores of Atypical symptoms and other symptom scores(chest pain, pharyngeal foreign body sensation, cough, etc) 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.
Time Frame
10 weeks
Title
the MOS item short from health survey (SF-36 scale)
Description
Observe the changes of SF-36 scale 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.
Time Frame
10 weeks
Title
Patient-Reported Outcome (Pro scale)
Description
Observe the changes of Pro scale 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.
Time Frame
10 weeks
Title
Hospital Anxiety and Depression Scale (HAD)
Description
Observe the changes of Hospital Anxiety and Depression Scale (had) 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.
Time Frame
10 weeks
Title
Visceral Sensitivity Scale (VSI)
Description
Observe the changes of Visceral Sensitivity Scale (VSI) 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.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fengyun Wang, professor
Phone
010-62835610
Email
wfy811@163.com
Facility Information:
Facility Name
Xiyuan Hospital of China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100091
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fengyun Wang, professor
Phone
+86(010)62835610
Email
wfy811@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessment on Effects of Tongjiang Granule in Treating Nonerosive Reflux Disease Overlapping Epigastric Pain Syndrome

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