ORIGINAL RESEARCH ARTICLE - CLINICAL | ||
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Raakhi K Tripathi1, Somesh S Bolegave1, Parvan A Shetty1, Dinesh A Uchil1, Nirmala N Rege1, Mukesh B Chawda2, Sameer A Rege3
1 Department of Clinical Pharmacology and Therapeutics, Seth G.S. Medical College and KEM Hospital, Mumbai, Maharashtra, India
2 Senior Manager, Medical Services, Solumiks Herbaceuticals Limited, Mumbai, Maharashtra, India
3 Department of General Surgery, Seth G.S. Medical College and KEM Hospital, Mumbai, Maharashtra, India
Date of Submission | 30-Jan-2015 |
Date of Decision | 09-Mar-2015 |
Date of Acceptance | 04-Jun-2015 |
Date of Web Publication | 22-Dec-2015 |
Correspondence Address:
Raakhi K Tripathi
Department of Pharmacology and Therapeutics, Seth G.S. Medical College and K.E.M. Hospital, Acharya Donde Marg, Parel (East), Mumbai - 400 012, Maharashtra
India
Raakhi K Tripathi
Department of Pharmacology and Therapeutics, Seth G.S. Medical College and K.E.M. Hospital, Acharya Donde Marg, Parel (East), Mumbai - 400 012, Maharashtra
India
Source of Support: None, Conflict of Interest: None
DOI: 10.4103/0975-9476.172382
Abstract |
Background: The medical management of hemorrhoids should include an integrated approach. This integrated approach can be achieved by polyherbal formulations containing anti-inflammatory, styptics, analgesics, and laxative effect which reduce inflammation, pain, and bleeding, and increase gastro-intestinal motility and soften stools. One such polyherbal kit is "Arshkeyt™, a 7 day kit," which consists of oral tablets and powder along with topical cream. Objective: Efficacy and safety of Arshkeyt™, a 7 day kit, a marketed polyherbal formulation was evaluated in comparison with conventional therapy practiced in surgery outpatient departments. Materials and Methods: Patients (n = 90) with hemorrhoids were randomly allocated to receive either Arshkeyt™ or standard therapy (combination of oral Isabgul powder and 2% lidocaine gel) for 14 days. Assessment on the basis of rectal symptoms and proctoscopic examination was done on day 0, 7, and 14 to derive a "composite score" which ranged from 0 to 25 by a blinded evaluator. The primary endpoint was number of patients achieving composite score 0 at the end of therapy (day 14). Inter-group analysis was done using Chi-square test. Results: On day 14, the composite score of 0 was achieved in 15 patients of Arshkeyt™ group versus 6 patients receiving standard therapy. The symptoms and signs which showed significant improvement in Arshkeyt™ group compared to standard treatment group were the tenesmus (visual analog score) score (P = 0.047), anal sphincter spasm (P = 0.0495) and a decrease in the grade of hemorrhoids (P = 0.0205) on day 14. Arshkeyt™ was also more beneficial in case of bleeding hemorrhoids as compared to nonbleeding hemorrhoids (P < 0.05). The incidence of adverse drug reactions in both groups was comparable and no patient required any treatment for the same. Conclusion: "Arshkeyt™, a 7 day kit," was effective in the treatment of hemorrhoids and had a good safety profile.
Keywords: Anal sphincter spasm, isabgul, rectal bleeding, tenesmus, 2% lidocaine gel
How to cite this article: Tripathi RK, Bolegave SS, Shetty PA, Uchil DA, Rege NN, Chawda MB, Rege SA. Efficacy and safety of a polyherbal formulation in hemorrhoids. J Ayurveda Integr Med 2015;6:225-32 |
How to cite this URL: Tripathi RK, Bolegave SS, Shetty PA, Uchil DA, Rege NN, Chawda MB, Rege SA. Efficacy and safety of a polyherbal formulation in hemorrhoids. J Ayurveda Integr Med [serial online] 2015 [cited 2016 Feb 20];6:225-32. Available from: http://www.jaim.in/text.asp? |