Functional Gastrointestinal Disorders, Healthy Subjects
Conditions
Keywords
Jing Si Herbal Tea Liquid Packet, psychophysical burden
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 unexplained 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 composed of eight native Taiwanese herbs (wormwood, 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 also has been registered in clinical trials as a complementary treatment for COVID-19. The preliminary data demonstrated that the Jing Si Herbal Tea 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 on psychophysical burden and metabolites of microbiota in patients with FD through a double-blind randomized manner.
Interventions
DIETARY_SUPPLEMENTJing 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.
DIETARY_SUPPLEMENTJing 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.
Sponsors
Buddhist Tzu Chi General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age between 20-79 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. 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. Have gastric pylori infection; 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, coldness, chronic diseases, poor kidney function, infants under three years old, children, Pregnancy, lactation, menstrual period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 Patient Assessment of Upper Gastrointestinal Symptoms(PAGI-SYM) at day 28 | Baseline and day 28 | Possible scores range from 0 (No pain) to 5 (Very serious) 0=No pain 1=Very slightly 2=Slight 3=About medium 4=Serious 5=Very serious Change = (day 28 Score - Baseline Score). |
Countries
Taiwan
Outcome results
None listed