Skip to main content
OpenTrials
Completed

NCT Number: NCT05668104

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Subjects COVID-19 Pneumonia Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Functional Gastrointestinal Disorders Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hualien Tzu Chi Hospital

Hualien City, 970, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Jing Si Herbal Tea Liquid Packet

Dietary Supplement

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.

Jing Si Herbal Tea Liquid Packet Placebo

Dietary Supplement

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

Primary outcomes

  1. Change from Baseline in Pain on the Visual Analogue Scale (VAS) at day 28

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Buddhist Tzu Chi General Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 29, 2022
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.