Clinical trial NCT05668104: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Buddhist Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2022-12-29
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Age between 20-70 years old.
2. 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).
3. 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) .
4. Be conscious and willing to sign the subject's consent form.

Exclusion Criteria:

1. Abnormal liver and kidney function;
2. Abnormal blood tests and thyroid abnormalities;
3. Have received surgery on the digestive tract;
4. Abnormal upper gastrointestinal endoscopy;
5. Abnormal colonoscopy;
6. Antibiotics are being used for infectious diseases;
7. Pregnant or breastfeeding women;
8. Suffering from heart, liver, or kidney failure;
9. Physical weakness, allergies, asthenia and cold constitution and chronic diseases.

Primary outcomes:
measure: Change from Baseline in Pain on the Visual Analogue Scale (VAS) at day 28
timeFrame: Baseline and day 28
measure: Change from Baseline in Pain on the Gastrointestinal symptom rating scale (GSRS) at day 28
timeFrame: Baseline and day 28
measure: Change from Baseline on the Pittsburgh sleep quality index (PSQI) at day 28
timeFrame: Baseline and day 28
measure: Change from Baseline on the Taiwanese Depression Scale (TDQ) at day 28
timeFrame: Baseline and day 28
measure: Change from Baseline on the State-Trait Anxiety Inventory (STAI) at day 28
timeFrame: Baseline and day 28
measure: Change from Baseline on the Perceived Stress Scale(PSS-10) at day 28
timeFrame: Baseline and day 28
measure: Change from Baseline on the Functional Dyspepsia Scale(FD) at day 28
timeFrame: Baseline and day 28
measure: Change from Baseline on the Irritable Bowel Syndrome Scale(IBS) at day 28
timeFrame: Baseline and day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Hualien City
country: Taiwan
facility: Hualien Tzu Chi Hospital
Study officials:
References:
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