An interventional study of Jing Si Herbal Tea Liquid Packet and Jing Si Herbal Tea Liquid Packet Placebo in Healthy Subjects, COVID-19 Pneumonia and Irritable Bowel Syndrome, sponsored by Buddhist Tzu Chi General Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-09.
Sponsored by Buddhist Tzu Chi General Hospital · Not applicable, Interventional, and Treatment
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.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 32 is below the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Buddhist Tzu Chi General Hospital is the lead sponsor of 84 studies on the registry; 21 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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
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
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.
Compared with the improvement effect of Jing Si Herbal Tea Liquid Packet, to avoid participants thinking that the improvement is due to psychological effects.
Also known as: Placebo
Change from Baseline in Pain on the Visual Analogue Scale (VAS) at day 28
Possible scores range from 0 (No pain) to 10 (Worst possible pain) Change = (day 28 Score - Baseline Score).
Time frame: Baseline and day 28
Change from Baseline in Pain on the Gastrointestinal symptom rating scale (GSRS) at 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).
Time frame: Baseline and day 28
Change from Baseline on the Pittsburgh sleep quality index (PSQI) at 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).
Time frame: Baseline and day 28
Change from Baseline on the Taiwanese Depression Scale (TDQ) at 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).
Time frame: Baseline and day 28
Change from Baseline on the State-Trait Anxiety Inventory (STAI) at 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).
Time frame: Baseline and day 28
Change from Baseline on the Perceived Stress Scale(PSS-10) at 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).
Time frame: Baseline and day 28
Change from Baseline on the Functional Dyspepsia Scale(FD) at 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).
Time frame: Baseline and day 28
Change from Baseline on the Irritable Bowel Syndrome Scale(IBS) at 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).
Time frame: Baseline and day 28
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Plan to share: No
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Buddhist Tzu Chi General Hospital