- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05948215
Jing Si Herbal Tea in the Treatment of Dyspeptic Symptoms
July 13, 2023 updated by: Buddhist Tzu Chi General Hospital
Jing Si Herbal Tea in the Treatment of Dyspeptic Symptoms and Psychophysical Burden in Patients With Functional dyspepsia--a Double-blind, Randomized, Placebo-controlled Study
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.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hualien City, Taiwan, 970
- Hualien Tzu Chi Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age between 20-79 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).
- 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;
- Have gastric pylori infection;
- Antibiotics are being used for infectious diseases;
- Pregnant or breastfeeding women;
- Suffering from heart, liver, or kidney failure;
- Physical weakness, allergies, coldness, chronic diseases, poor kidney function, infants under three years old, children, Pregnancy, lactation, menstrual period.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Jing Si Herbal Tea Liquid Packet
Participants received Jing Si Herbal Tea Liquid Packet 15 mg tablet orally once daily for 28 days.
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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.
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Placebo Comparator: Jing Si Herbal Tea Liquid Packet Placebo
Participants received Jing Si Herbal Tea Liquid Packet Placebo 15 mg tablet orally once daily for 28 days.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Pain on the Visual Analogue Scale (VAS) at day 28
Time Frame: Baseline and day 28
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Possible scores range from 0 (No pain) to 10 (Worst possible pain) Change = (day 28 Score - Baseline Score).
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Baseline and day 28
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Change from Baseline on the Pittsburgh sleep quality index (PSQI) at day 28
Time Frame: Baseline and day 28
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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).
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Baseline and day 28
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Change from Baseline on the Taiwanese Depression Scale (TDQ) at day 28
Time Frame: Baseline and day 28
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Possible scores range from 0 (Never) to 3 (Always) 0=Never 1=Sometimes 2=Often 3=Always Change = (day 28 Score - Baseline Score).
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Baseline and day 28
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Change from Baseline on the State-Trait Anxiety Inventory (STAI) at day 28
Time Frame: Baseline and day 28
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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
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Change from Baseline on the Perceived Stress Scale(PSS-10) at day 28
Time Frame: Baseline and day 28
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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).
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Baseline and day 28
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Change from Baseline on the Patient Assessment of Upper Gastrointestinal Symptoms(PAGI-SYM) at day 28
Time Frame: Baseline and day 28
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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).
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Baseline and day 28
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Gwee KA, Holtmann G, Tack J, Suzuki H, Liu J, Xiao Y, Chen MH, Hou X, Wu DC, Toh C, Lu F, Tang XD. Herbal medicines in functional dyspepsia-Untapped opportunities not without risks. Neurogastroenterol Motil. 2021 Feb;33(2):e14044. doi: 10.1111/nmo.14044. Epub 2020 Nov 30.
- Sperber AD, Bangdiwala SI, Drossman DA, Ghoshal UC, Simren M, Tack J, Whitehead WE, Dumitrascu DL, Fang X, Fukudo S, Kellow J, Okeke E, Quigley EMM, Schmulson M, Whorwell P, Archampong T, Adibi P, Andresen V, Benninga MA, Bonaz B, Bor S, Fernandez LB, Choi SC, Corazziari ES, Francisconi C, Hani A, Lazebnik L, Lee YY, Mulak A, Rahman MM, Santos J, Setshedi M, Syam AF, Vanner S, Wong RK, Lopez-Colombo A, Costa V, Dickman R, Kanazawa M, Keshteli AH, Khatun R, Maleki I, Poitras P, Pratap N, Stefanyuk O, Thomson S, Zeevenhooven J, Palsson OS. Worldwide Prevalence and Burden of Functional Gastrointestinal Disorders, Results of Rome Foundation Global Study. Gastroenterology. 2021 Jan;160(1):99-114.e3. doi: 10.1053/j.gastro.2020.04.014. Epub 2020 Apr 12.
- Stanghellini V, Chan FK, Hasler WL, Malagelada JR, Suzuki H, Tack J, Talley NJ. Gastroduodenal Disorders. Gastroenterology. 2016 May;150(6):1380-92. doi: 10.1053/j.gastro.2016.02.011.
- Talley NJ, Ford AC. Functional Dyspepsia. N Engl J Med. 2015 Nov 5;373(19):1853-63. doi: 10.1056/NEJMra1501505. No abstract available.
- Wauters L, Talley NJ, Walker MM, Tack J, Vanuytsel T. Novel concepts in the pathophysiology and treatment of functional dyspepsia. Gut. 2020 Mar;69(3):591-600. doi: 10.1136/gutjnl-2019-318536. Epub 2019 Nov 29.
- Masuy I, Van Oudenhove L, Tack J. Review article: treatment options for functional dyspepsia. Aliment Pharmacol Ther. 2019 May;49(9):1134-1172. doi: 10.1111/apt.15191. Epub 2019 Mar 28.
- Ford AC, Moayyedi P, Black CJ, Yuan Y, Veettil SK, Mahadeva S, Kengkla K, Chaiyakunapruk N, Lee YY. Systematic review and network meta-analysis: efficacy of drugs for functional dyspepsia. Aliment Pharmacol Ther. 2021 Jan;53(1):8-21. doi: 10.1111/apt.16072. Epub 2020 Sep 16.
- Teschke R, Wolff A, Frenzel C, Eickhoff A, Schulze J. Herbal traditional Chinese medicine and its evidence base in gastrointestinal disorders. World J Gastroenterol. 2015 Apr 21;21(15):4466-90. doi: 10.3748/wjg.v21.i15.4466.
- Suzuki H, Matsuzaki J, Fukushima Y, Suzaki F, Kasugai K, Nishizawa T, Naito Y, Hayakawa T, Kamiya T, Andoh T, Yoshida H, Tokura Y, Nagata H, Kobayakawa M, Mori M, Kato K, Hosoda H, Takebayashi T, Miura S, Uemura N, Joh T, Hibi T, Tack J; Rikkunshito study group. Randomized clinical trial: rikkunshito in the treatment of functional dyspepsia--a multicenter, double-blind, randomized, placebo-controlled study. Neurogastroenterol Motil. 2014 Jul;26(7):950-61. doi: 10.1111/nmo.12348. Epub 2014 Apr 28.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
July 5, 2023
First Submitted That Met QC Criteria
July 13, 2023
First Posted (Actual)
July 17, 2023
Study Record Updates
Last Update Posted (Actual)
July 17, 2023
Last Update Submitted That Met QC Criteria
July 13, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB110-232-A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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