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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jing Si Herbal Tea Liquid Packet | Experimental | Participants received Jing Si Herbal Tea Liquid Packet 15 mg tablet orally once daily for 28 days. |
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| Jing Si Herbal Tea Liquid Packet Placebo | Placebo Comparator | Participants received Jing Si Herbal Tea Liquid Packet Placebo 15 mg tablet orally once daily for 28 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Change from Baseline on the Patient Assessment of Upper Gastrointestinal Symptoms(PAGI-SYM) at 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hualien Tzu Chi Hospital | Hualien City | 970 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32294476 | Result | 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. | |
| 27147122 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 9, 2022 | Jul 13, 2023 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 9, 2022 | Jul 13, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| 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. |
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| Baseline and day 28 |
| Result |
| 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. |
| 26535514 | Result | Talley NJ, Ford AC. Functional Dyspepsia. N Engl J Med. 2015 Nov 5;373(19):1853-63. doi: 10.1056/NEJMra1501505. No abstract available. |
| 31784469 | Result | 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. |
| 33258198 | Result | 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. |
| 30924176 | Result | 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. |
| 32936964 | Result | 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. |
| 25914456 | Result | 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. |
| 24766295 | Result | 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. |
| 27144617 | Result | 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. |