Efficacy and safety of Trang Phuc Linh Plus tablets in patients with irritable bowel syndrome-diarrhea
Nội dung chính của bài viết
Tóm tắt
A double-blind, randomized, phase II clinical trial was conducted within a 14-week follow-up including 2 weeks of the non-drug run-in period, 8 weeks of medication, and 4 weeks of follow-up after discontinuation. The objective of the study was to evaluate the efficacy and safety of Trang Phuc Linh Plus in irritable diarrhea syndrome patients. Group I took Trang Phuc Linh Plus 3 tablets/time x 2 times/day for 8 weeks; Group II took placebo 3 tablets/time x 2 times/day for 8 weeks. Patients will be re-examined, tested, and evaluated over the phone for symptom recurrence and adverse events (AEs). This study showed that the Trang Phuc Linh Plus tablets tended to improve symptoms in patients suffering from irritable bowel syndrome with diarrhea, suggesting its safety and tolerability.
Chi tiết bài viết
Từ khóa
IBSS01, Trang Phuc Linh Plus, irritable bowel syndrome
Tài liệu tham khảo
2. Romano C, Comito D, Famiani A, Calamarà S, Loddo I. Partially hydrolyzed guar gum in pediatric functional abdominal pain. World J Gastroenterol. 2013;19(2):235-240.
3. Nguyen Thi Tuyet Van. Study on the diagnostic status of digestive diseases at Bach Mai internal clinic from August 2003 to July 2004. Published online 2004.
4. Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012;10(7):712-721.
5. Canavan C, West J, Card T. The epidemiology of irritable bowel syndrome. Clin Epidemiol. 2014;6:71-80.
6. Circular 29/2018/TT-BYT Circular Regulations on Clinical Trials.
7. U.S. Department of Health and Human Services. Guidance for Industry Irritable Bowel Syndrome - Clinical Evaluation of Drugs for Treatment. Published online 2012.
8. Johannsen L, Wecke J, Obál F, Krueger JM. Macrophages produce somnogenic and pyrogenic muramyl peptides during digestion of staphylococci. Am J Physiol. 1991;260:126-133.
9. West N, Pyne D, Cripps A, et al. Lactobacillus fermentum (PCC) supplementation and gastrointestinal and respiratory-tract illness symptoms: A randomised control trial in athletes. Nutrition journal. 2011;10:30.
10. Zighelboim J, Talley NJ, Phillips SF, Harmsen WS, Zinsmeister AR. Visceral perception in irritable bowel syndrome. Rectal and gastric responses to distension and serotonin type 3 antagonism. Dig Dis Sci. 1995;40(4):819-827.
11. Gershon MD. Serotonin and its implication for the management of irritable bowel syndrome. Rev Gastroenterol Disord. 2003;3 Suppl 2:25-34.
12. Nguyen TT, Dau DT, Nguyen DC, et al. Effects of Trang Phuc Linh Plus-Food Supplement on Irritable Bowel Syndrome Induced by Mustard Oil. J Med Food. 2017;20(4):385-391.
13. Nee J, Zakari M, Lembo AJ. Current and emerging drug options in the treatment of diarrhea predominant irritable bowel syndrome. Expert Opin Pharmacother. 2015;16(18):2781-2792.
14. Zheng H, Jin S, Shen Y-L, et al. Chinese Herbal Medicine for Irritable Bowel Syndrome: A Meta-Analysis and Trial Sequential Analysis of Randomized Controlled Trials. Front Pharmacol. 2021;12:694741.