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

Buddhist Tzu Chi General Hospital

Status: Completed

Conditions: Irritable Bowel Syndrome; COVID-19 Pneumonia; Functional Gastrointestinal Disorders; Healthy Subjects

Treatments: Dietary Supplement: Jing Si Herbal Tea Liquid Packet; Dietary Supplement: Jing Si Herbal Tea Liquid Packet Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05668104

IRB111-232-A

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

Jing Si Herbal Tea Liquid Packet

Experimental group

Description:

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

Treatment:

Dietary Supplement: Jing Si Herbal Tea Liquid Packet

Jing Si Herbal Tea Liquid Packet Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Jing Si Herbal Tea Liquid Packet Placebo