20. Assesing the effect of Tri Thien Duoc capsule on stage II hemorrhaging internal hemorrhoids patients: A phase II randomized control, double blind clinical trial

Pham Duc Huan, Le Thanh Xuan, Le Thi Minh Phuong

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Abstract

The study was designed to evaluate the treatment effect and the safety of Tri Thien Duoc capsule on stage II internal hemorrhoids patients. This is a randomized clinical trial double blind, placebo-controlled group . 75 bleeding stage II internal hemorrhoids patients were divided into two groups with a rate of 2:1. Tri Thien Duoc group included 50 patients with a dose of 8 capsules/day for 14 days. Placebo group included 25 patients with placebo 8 capsules/day for 14 days. Results in 58 patient of two similar characteristics groups suggested that Tri Thien Duoc may improved symptoms of bleeding on stage II internal hemorrhoids patients through decreased days of bleeding (2.1 ± 1.8 days in Tri Thien Duoc group) in comparison with the placebo group (5 ± 5 day) (p <0.05); reduced degree of bleeding with 82.2% of patients stopped of bleeding; reduced Wexner score, VAS score and congestion degree of hemorrhoids, in comparison with baseline (p > 0.05). There was no adverse side effects observed in all patients.

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References

1. Migaly J Sun Z. Review of Hemorrhoid Disease: Presentation and Management. Clin Colon Rectal Surg. 2016; 29(1), 22-9. doi: 10.1055/s-0035-1568144.
2. Lohsiriwat V. Hemorrhoids: from basic pathophysiology to clinical management. World journal of gastroenterology. 2012; 18(17), doi:10.3748/wjg.v18.i17.
3. Nguyễn Mạnh Nhâm, và cộng sự. Nghiên cứu bệnh trĩ ở các tỉnh miền Bắc Việt Nam, các biện pháp phòng bệnh, điều trị, Tạp chí Hậu môn trực tràng. 2014; 6, 7.
4. Olumayokun A. Olajide, Babatunde R. Ogunleye & Temitope O. Erinle. Anti-inflammatory Properties of Amaranthus spinosus Leaf Extract. Pharmaceutical Biology. 2004; 42(7), 521-525, DOI: 10.3109/13880200490893285.
5. Hashempur MH, Khademi F, Rahmanifard M, Zarshenas MM. An Evidence-Based Study on Medicinal Plants for Hemorrhoids in Medieval Persia. J Evid Based Complementary Altern Med. 2017; 22(4), 969-981. doi:10.1177/2156587216688597.
6. Rao J, Jayasree T, Mallikarjuna Rao B, et al. Evaluation of the anti-nociceptive and anti-inflammatory activities of the pet:ether extract of Portulaca oleracea (Linn.). J Clin Diagn Res. 2012; 6, 226–230.
7. Phạm Thị Vân Anh, Nguyễn Ngọc Trâm, và cộng sự. Nghiên cứu tác dụng điều trị trĩ của viên Trĩ Thiên Dươc trên thực nghiệm, Báo cáo Chuyên đề thực nghiệm đề tài khoa học công nghệ nhánh cấp Nhà nước. 2018.
8. Phạm Đức Huấn, Lê Thành Xuân, Lê Thị Minh Phương, và cs. Thử nghiệm lâm sàng giai đoạn I đánh giá tính an toàn của viên Trĩ Thiên Dược. Báo cáo chuyên đề đề tài Khoa học công nghệ nhánh cấp Nhà nước. 2019.
9. American Gastroenterological Association, American Gastroenterological Association medical position statement: Diagnosis and treatment of hemorrhoids. Gastroenterology. 2004; 126, 1461 - 1462.
10. Gan T, Liu YD, Wang Y, Yang J. (2010), Traditional Chinese Medicine herbs for stopping bleeding from haemorrhoids. Cochrane Database of Systematic Reviews 2010. Issue 10. Art. No.: CD006791.
11. Dworkin RH., Turk DC., Wywrich KW., et al. (2008). Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials. IMMPACT recommendations. J Pain 2008, 9, 105 - 21.
12. Wexner S. D, Jorge J. M. N. Etiology and management of fecal incontinence. Diseases of the Colon & Rectum. 1993; 36(1), 77-97.