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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05668104
• Other study ID #: IRB111-232-A
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2022
• Source: Buddhist Tzu Chi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19 Pneumonia
• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases
• Healthy Subjects
• Irritable Bowel Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Hualien Tzu Chi Hospital	Hualien City

Sponsors (1)

Lead Sponsor	Collaborator
Buddhist Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (16)

Chen Y, Gu S, Chen Y, Lu H, Shi D, Guo J, Wu WR, Yang Y, Li Y, Xu KJ, Ding C, Luo R, Huang C, Yu L, Xu M, Yi P, Liu J, Tao JJ, Zhang H, Lv L, Wang B, Sheng J, Li L. Six-month follow-up of gut microbiota richness in patients with COVID-19. Gut. 2022 Jan;71 — View Citation

Cheung KS, Hung IFN, Chan PPY, Lung KC, Tso E, Liu R, Ng YY, Chu MY, Chung TWH, Tam AR, Yip CCY, Leung KH, Fung AY, Zhang RR, Lin Y, Cheng HM, Zhang AJX, To KKW, Chan KH, Yuen KY, Leung WK. Gastrointestinal Manifestations of SARS-CoV-2 Infection and Virus — View Citation

Drossman DA. Functional Gastrointestinal Disorders: History, Pathophysiology, Clinical Features and Rome IV. Gastroenterology. 2016 Feb 19:S0016-5085(16)00223-7. doi: 10.1053/j.gastro.2016.02.032. Online ahead of print. — View Citation

Fan Y, Pedersen O. Gut microbiota in human metabolic health and disease. Nat Rev Microbiol. 2021 Jan;19(1):55-71. doi: 10.1038/s41579-020-0433-9. Epub 2020 Sep 4. — View Citation

Golla R, Vuyyuru SK, Kante B, Kedia S, Ahuja V. Disorders of gut-brain interaction in post-acute COVID-19 syndrome. Postgrad Med J. 2022 Jul 1:postgradmedj-2022-141749. doi: 10.1136/pmj-2022-141749. Online ahead of print. — View Citation

Hazan S, Stollman N, Bozkurt HS, Dave S, Papoutsis AJ, Daniels J, Barrows BD, Quigley EM, Borody TJ. Lost microbes of COVID-19: Bifidobacterium, Faecalibacterium depletion and decreased microbiome diversity associated with SARS-CoV-2 infection severity. B — View Citation

Hsieh PC, Chao YC, Tsai KW, Li CH, Tzeng IS, Wu YK, Shih CY. Efficacy and Safety of Complementary Therapy With Jing Si Herbal Tea in Patients With Mild-To-Moderate COVID-19: A Prospective Cohort Study. Front Nutr. 2022 Mar 14;9:832321. doi: 10.3389/fnut.2 — View Citation

Mao R, Qiu Y, He JS, Tan JY, Li XH, Liang J, Shen J, Zhu LR, Chen Y, Iacucci M, Ng SC, Ghosh S, Chen MH. Manifestations and prognosis of gastrointestinal and liver involvement in patients with COVID-19: a systematic review and meta-analysis. Lancet Gastro — View Citation

Margolis KG, Cryan JF, Mayer EA. The Microbiota-Gut-Brain Axis: From Motility to Mood. Gastroenterology. 2021 Apr;160(5):1486-1501. doi: 10.1053/j.gastro.2020.10.066. Epub 2021 Jan 22. — View Citation

Mazzawi T. Gut Microbiota Manipulation in Irritable Bowel Syndrome. Microorganisms. 2022 Jun 30;10(7):1332. doi: 10.3390/microorganisms10071332. — View Citation

Schmulson M, Ghoshal UC, Barbara G. Managing the Inevitable Surge of Post-COVID-19 Functional Gastrointestinal Disorders. Am J Gastroenterol. 2021 Jan 1;116(1):4-7. doi: 10.14309/ajg.0000000000001062. No abstract available. — View Citation

Su Q, Lau RI, Liu Q, Chan FKL, Ng SC. Post-acute COVID-19 syndrome and gut dysbiosis linger beyond 1 year after SARS-CoV-2 clearance. Gut. 2023 Jun;72(6):1230-1232. doi: 10.1136/gutjnl-2022-328319. Epub 2022 Aug 8. No abstract available. — View Citation

Tian Y, Sun KY, Meng TQ, Ye Z, Guo SM, Li ZM, Xiong CL, Yin Y, Li HG, Zhou LQ. Gut Microbiota May Not Be Fully Restored in Recovered COVID-19 Patients After 3-Month Recovery. Front Nutr. 2021 May 13;8:638825. doi: 10.3389/fnut.2021.638825. eCollection 202 — View Citation

Wauters L, Ceulemans M, Schol J, Farre R, Tack J, Vanuytsel T. The Role of Leaky Gut in Functional Dyspepsia. Front Neurosci. 2022 Mar 29;16:851012. doi: 10.3389/fnins.2022.851012. eCollection 2022. — View Citation

Zhou L, Zeng Y, Zhang H, Ma Y. The Role of Gastrointestinal Microbiota in Functional Dyspepsia: A Review. Front Physiol. 2022 Jun 8;13:910568. doi: 10.3389/fphys.2022.910568. eCollection 2022. — View Citation

Zuo T, Wu X, Wen W, Lan P. Gut Microbiome Alterations in COVID-19. Genomics Proteomics Bioinformatics. 2021 Oct;19(5):679-688. doi: 10.1016/j.gpb.2021.09.004. Epub 2021 Sep 21. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline and day 28
Primary	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).	Baseline and day 28
Primary	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).	Baseline and day 28
Primary	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).	Baseline and day 28
Primary	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).	Baseline and day 28
Primary	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).	Baseline and day 28
Primary	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).	Baseline and day 28
Primary	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).	Baseline and day 28