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

Not Applicable

Completed

• Conditions: COVID-19 Pneumonia; Irritable Bowel Syndrome; Healthy Subjects; Functional Gastrointestinal Disorders
• Interventions: Dietary Supplement: Jing Si Herbal Tea Liquid Packet Placebo; Dietary Supplement: Jing Si Herbal Tea Liquid Packet

• Registration Number: NCT05668104
• Lead Sponsor: Buddhist Tzu Chi General Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-26
• Study First Submitted QC: 2022-12-26
• Study First Posted: 2022-12-29
• Study Start: 2023-01-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change from Baseline on the Taiwanese Depression Scale (TDQ) at day 28	Baseline and 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 Irritable Bowel Syndrome Scale(IBS) at day 28	Baseline and 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).
Change from Baseline in Pain on the Visual Analogue Scale (VAS) at day 28	Baseline and 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	Baseline and 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 State-Trait Anxiety Inventory (STAI) at day 28	Baseline and 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 Pittsburgh sleep quality index (PSQI) at day 28	Baseline and 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 Perceived Stress Scale(PSS-10) at day 28	Baseline and 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	Baseline and 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).

Trial Locations

Locations (1)

Hualien Tzu Chi Hospital; 🇨🇳 Hualien City, Taiwan