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Jing Si Herbal Tea for Long-Coronavirus Disease(COVID) Gut-brain Interaction

Primary Purpose

Healthy Subjects, COVID-19 Pneumonia, Irritable Bowel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Jing Si Herbal Tea Liquid Packet
Jing Si Herbal Tea Liquid Packet Placebo
Sponsored by
Buddhist Tzu Chi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Subjects focused on measuring functional dyspepsia, Jing Si Herbal Tea Liquid Packet, psychophysical burden, Gut-brain axis dysregulation

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age between 20-70 years old. Those who meet the definition of functional dyspepsia (FD). (Functional dyspepsia (FD) is chronic (once a week, lasting at least three months, at least six months before the first symptom) upper gastrointestinal symptoms (any of the following): postprandial abdominal distension, easy to feel full, Epigastric pain or burning sensation in the upper abdomen, and no symptoms of gastrointestinal bleeding or significant weight loss, no abnormality after upper gastrointestinal endoscopy). Those who meet the definition of irritable bowel syndrome (IBS). (Irritable bowel syndrome (IBS) is chronic (once a week, lasting for at least three months) lower gastrointestinal symptoms: abdominal pain combined with diarrhea or constipation, and no symptoms of gastrointestinal bleeding or significant weight loss, no abnormalities after colonoscopy) . Be conscious and willing to sign the subject's consent form. Exclusion Criteria: Abnormal liver and kidney function; Abnormal blood tests and thyroid abnormalities; Have received surgery on the digestive tract; Abnormal upper gastrointestinal endoscopy; Abnormal colonoscopy; Antibiotics are being used for infectious diseases; Pregnant or breastfeeding women; Suffering from heart, liver, or kidney failure; Physical weakness, allergies, asthenia and cold constitution and chronic diseases.

Sites / Locations

  • Hualien Tzu Chi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Jing Si Herbal Tea Liquid Packet

Jing Si Herbal Tea Liquid Packet Placebo

Arm Description

Participants received Jing Si Herbal Tea Liquid Packet 15 mg tablet orally twice daily for 28 days.

Participants received Jing Si Herbal Tea Liquid Packet Placebo 15 mg tablet orally twice daily for 28 days.

Outcomes

Primary Outcome Measures

Change from Baseline in Pain on the Visual Analogue Scale (VAS) at day 28
Possible scores range from 0 (No pain) to 10 (Worst possible pain) Change = (day 28 Score - Baseline Score).
Change from Baseline in Pain on the Gastrointestinal symptom rating scale (GSRS) at day 28
Possible scores range from 1 (No pain) to 4 (Worst possible pain) 1=No pain 2=Mild 3=Moderate 4=Worst possible pain Change = (day 28 Score - Baseline Score).
Change from Baseline on the Pittsburgh sleep quality index (PSQI) at day 28
Possible scores range from 0 (Never) to 3 (Occurs three times a week times or more) 0=Never 1=Less than once a week 2=Occurs once or twice a week 3=Occurs three times a week times or more Change = (day 28 Score - Baseline Score).
Change from Baseline on the Taiwanese Depression Scale (TDQ) at day 28
Possible scores range from 0 (Never) to 3 (Always) 0=Never 1=Sometimes 2=Often 3=Always Change = (day 28 Score - Baseline Score).
Change from Baseline on the State-Trait Anxiety Inventory (STAI) at day 28
Possible scores range from 1 (Never) to 4 (Always) 1=Never 2=Sometimes 3=Often 4=Always Change = (day 28 Score - Baseline Score).
Change from Baseline on the Perceived Stress Scale(PSS-10) at day 28
Possible scores range from 0 (Never) to 4 (Always) 0=Never 1=Rarely 2=Sometimes 3=Often 4=Always Change = (day 28 Score - Baseline Score).
Change from Baseline on the Functional Dyspepsia Scale(FD) at day 28
Possible scores range from 0 (Very slightly) to 6 (Very serious) 0=Very slightly 1=Slight 2=A little slightly 3=About medium 4=A bit serious 5=Severe 6=Very serious Change = (day 28 Score - Baseline Score).
Change from Baseline on the Irritable Bowel Syndrome Scale(IBS) at day 28
Possible scores range from 1 (Never) to 5 (Always) 1=Never 2=Sometimes 3=Often4=most of the time 5=Always Change = (day 28 Score - Baseline Score).

Secondary Outcome Measures

Full Information

First Posted
December 26, 2022
Last Updated
June 28, 2023
Sponsor
Buddhist Tzu Chi General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05668104
Brief Title
Jing Si Herbal Tea for Long-Coronavirus Disease(COVID) Gut-brain Interaction
Official Title
Jing Si Herbal Tea Liquid Packet in the Treatment of Dyspeptic Symptoms and Psychophysical Burden in Patients With Disorders of Long-Coronavirus Disease(COVID) Gut-brain Interaction --a Double-blind, Randomized, Placebo Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Buddhist Tzu Chi General Hospital

4. Oversight

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

5. Study Description

Brief Summary
Dyspepsia refers to chronic or recurrent upper gastrointestinal symptoms. According to the Rome IV criteria, functional dyspepsia (FD) symptoms included meal related fullness, early satiation, epigastric pain or burning which are unexpl ained after routine investigation. FD causes substantial psychophysical burden because of its unknown etiology and high prevalence. Although FD is currently associated with local inflammation of the gastrointestinal tract and microbiota alteration, current available treatments for FD are of limited effectiveness. In view of this, many studies have applied Chinese herbal medicine in FD and achieved some therapeutic benefit. The Jing Si Herbal Tea Liquid Packet composed of eight native Taiwanese herbs (wormwo od, hickory grass, Ophiopogon japonicus, houttuynia cordata, platycodon,licorice, perilla leaves, chrysanthemum) has obtained a special export license from the Ministry of Health and Welfare. The Jing Si Herbal Tea Liquid Packet also has been registered i n clinical trials as a complementary treatment for Coronavirus disease 2019(COVID-19). The preliminary data demonstrated that the Jing Si Herbal Tea Liquid Packet may improve gastrointestinal symptoms and anxiety in patients with COVID-19. Therefore,this study aims to investigate the impact of the Jing Si Herbal Tea Liquid Packet on psychophysical burden and metabolites of microbiota in patients with FD through a double blind randomized manner.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects, COVID-19 Pneumonia, Irritable Bowel Syndrome, Functional Gastrointestinal Disorders
Keywords
functional dyspepsia, Jing Si Herbal Tea Liquid Packet, psychophysical burden, Gut-brain axis dysregulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Jing Si Herbal Tea Liquid Packet
Arm Type
Experimental
Arm Description
Participants received Jing Si Herbal Tea Liquid Packet 15 mg tablet orally twice daily for 28 days.
Arm Title
Jing Si Herbal Tea Liquid Packet Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received Jing Si Herbal Tea Liquid Packet Placebo 15 mg tablet orally twice daily for 28 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Jing Si Herbal Tea Liquid Packet
Intervention Description
The preliminary data demonstrated that the Jing Si Herbal Tea Liquid Packet may improve gastrointestinal symptoms and anxiety in patients with Coronavirus disease 2019(COVID-19). Therefore,this study aims to investigate the impact of the Jing Si Herbal Tea Liquid Packet on psychophysical burden and metabolites of microbiota in patients with FD through a double-blind randomized manner.
Intervention Type
Dietary Supplement
Intervention Name(s)
Jing Si Herbal Tea Liquid Packet Placebo
Other Intervention Name(s)
Placebo
Intervention Description
Compared with the improvement effect of Jing Si Herbal Tea Liquid Packet, to avoid participants thinking that the improvement is due to psychological effects.
Primary Outcome Measure Information:
Title
Change from Baseline in Pain on the Visual Analogue Scale (VAS) at day 28
Description
Possible scores range from 0 (No pain) to 10 (Worst possible pain) Change = (day 28 Score - Baseline Score).
Time Frame
Baseline and day 28
Title
Change from Baseline in Pain on the Gastrointestinal symptom rating scale (GSRS) at day 28
Description
Possible scores range from 1 (No pain) to 4 (Worst possible pain) 1=No pain 2=Mild 3=Moderate 4=Worst possible pain Change = (day 28 Score - Baseline Score).
Time Frame
Baseline and day 28
Title
Change from Baseline on the Pittsburgh sleep quality index (PSQI) at day 28
Description
Possible scores range from 0 (Never) to 3 (Occurs three times a week times or more) 0=Never 1=Less than once a week 2=Occurs once or twice a week 3=Occurs three times a week times or more Change = (day 28 Score - Baseline Score).
Time Frame
Baseline and day 28
Title
Change from Baseline on the Taiwanese Depression Scale (TDQ) at day 28
Description
Possible scores range from 0 (Never) to 3 (Always) 0=Never 1=Sometimes 2=Often 3=Always Change = (day 28 Score - Baseline Score).
Time Frame
Baseline and day 28
Title
Change from Baseline on the State-Trait Anxiety Inventory (STAI) at day 28
Description
Possible scores range from 1 (Never) to 4 (Always) 1=Never 2=Sometimes 3=Often 4=Always Change = (day 28 Score - Baseline Score).
Time Frame
Baseline and day 28
Title
Change from Baseline on the Perceived Stress Scale(PSS-10) at day 28
Description
Possible scores range from 0 (Never) to 4 (Always) 0=Never 1=Rarely 2=Sometimes 3=Often 4=Always Change = (day 28 Score - Baseline Score).
Time Frame
Baseline and day 28
Title
Change from Baseline on the Functional Dyspepsia Scale(FD) at day 28
Description
Possible scores range from 0 (Very slightly) to 6 (Very serious) 0=Very slightly 1=Slight 2=A little slightly 3=About medium 4=A bit serious 5=Severe 6=Very serious Change = (day 28 Score - Baseline Score).
Time Frame
Baseline and day 28
Title
Change from Baseline on the Irritable Bowel Syndrome Scale(IBS) at day 28
Description
Possible scores range from 1 (Never) to 5 (Always) 1=Never 2=Sometimes 3=Often4=most of the time 5=Always Change = (day 28 Score - Baseline Score).
Time Frame
Baseline and day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age between 20-70 years old. Those who meet the definition of functional dyspepsia (FD). (Functional dyspepsia (FD) is chronic (once a week, lasting at least three months, at least six months before the first symptom) upper gastrointestinal symptoms (any of the following): postprandial abdominal distension, easy to feel full, Epigastric pain or burning sensation in the upper abdomen, and no symptoms of gastrointestinal bleeding or significant weight loss, no abnormality after upper gastrointestinal endoscopy). Those who meet the definition of irritable bowel syndrome (IBS). (Irritable bowel syndrome (IBS) is chronic (once a week, lasting for at least three months) lower gastrointestinal symptoms: abdominal pain combined with diarrhea or constipation, and no symptoms of gastrointestinal bleeding or significant weight loss, no abnormalities after colonoscopy) . Be conscious and willing to sign the subject's consent form. Exclusion Criteria: Abnormal liver and kidney function; Abnormal blood tests and thyroid abnormalities; Have received surgery on the digestive tract; Abnormal upper gastrointestinal endoscopy; Abnormal colonoscopy; Antibiotics are being used for infectious diseases; Pregnant or breastfeeding women; Suffering from heart, liver, or kidney failure; Physical weakness, allergies, asthenia and cold constitution and chronic diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-Wun Wong
Phone
+886 8561825
Ext
13224
Email
hypertr42@gmail.com
Facility Information:
Facility Name
Hualien Tzu Chi Hospital
City
Hualien City
ZIP/Postal Code
970
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming-Wun Wong
Phone
+886 8561825
Ext
13224
Email
hypertr42@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Jing Si Herbal Tea for Long-Coronavirus Disease(COVID) Gut-brain Interaction

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