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

Sponsor
Buddhist Tzu Chi General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05668104
Collaborator
(none)
150
1
2
12
12.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Jing Si Herbal Tea Liquid Packet
  • Dietary Supplement: Jing Si Herbal Tea Liquid Packet Placebo
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Jing Si Herbal Tea Liquid Packet

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

Dietary Supplement: Jing Si Herbal Tea Liquid Packet
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.

Placebo Comparator: 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.

Dietary Supplement: Jing Si Herbal Tea Liquid Packet Placebo
Compared with the improvement effect of Jing Si Herbal Tea Liquid Packet, to avoid participants thinking that the improvement is due to psychological effects.
Other Names:
  • Placebo
  • Outcome Measures

    Primary Outcome Measures

    1. 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).

    2. 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).

    3. 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).

    4. 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).

    5. 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).

    6. 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).

    7. 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).

    8. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hualien Tzu Chi Hospital Hualien City Taiwan 970

    Sponsors and Collaborators

    • Buddhist Tzu Chi General Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Buddhist Tzu Chi General Hospital
    ClinicalTrials.gov Identifier:
    NCT05668104
    Other Study ID Numbers:
    • IRB111-232-A
    First Posted:
    Dec 29, 2022
    Last Update Posted:
    Jan 4, 2023
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Buddhist Tzu Chi General Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 4, 2023