A Prospective, Randomized, Active-Controlled, Two-Arm,Parallel Group, Assessor-Blind Study To Compare The Efficacy And Safety Of Arsha Hita In The Treatment Of Anal Fissure

Shree Dhootapapeshwar Limited1 个研究点分布在 1 个国家目标入组 72 人开始时间: 2020年2月14日最近更新: 2020年7月2日

试验速览

阶段: 2/3 期
状态: 尚未招募
发起方: Shree Dhootapapeshwar Limited
入组人数: 72
试验地点: 1
主要终点: Arsha Hitagroup as compared with the standard treatment

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The use of topical agents in analfissures like lignocaine, nitrates, diltiazem as well as the use ofconservative treatment like sitz bath, isabgol and high fiber diet has not beenfound to completely relieve the patients from the signs and symptoms. Thetopical treatment like nitrates and diltiazem are associated with variousside-effects. 20% of the patients on nitrates suffer from headaches while 15%of the patients on diltiazem complain of itching. Many of the patients of acuteanal fissure progress to chronic anal fissure. Also, the surgical treatment ofanal fissures is associated with complications like anal incontinence, withpost-surgical recurrences of anal fissures also reported. Arsha Hita, a polyherbal formulation kit, is beingmarketed from 10 years and is indicated in bleeding, pain, anal discomfort andinflammation associated with haemorrhoids. However, no validation study hasbeen conducted to check its efficacy in the treatment of anal fissures. Thus, asingle centre, prospective, randomized, active-controlled, two-arm, parallelgroup, assessor blind study is planned to validate the efficacy of Arsha Hita in patients of anal fissures.

研究设计

研究类型: Interventional
分配方式: Adaptive randomization, such as minimization
盲法: Outcome Assessor Blinded

入排标准

年龄范围: 18.00 Year(s) 至 60.00 Year(s)（—）
性别: All

入选标准

•1.Adult patients aged between
•60 years of either sex.
•Patients with a confirmed diagnosis of anal fissure
•Patients with previous history of no treatment or only conservative treatment, consisting of sitz bath and/or Isabgol powder and/or high fibre diet in the last 1 month.
•Patients with a composite score of > 4 at baseline visit.

排除标准

•1.Patients having anal fistulas or anal fissure of various causes such as Crohnâ€™s disease, anal suppuration, abscesses (Secondary underlying causes).
•2.Patients having anal or perianal malignancy.
•3.Patients with diagnosis of any illness (other than anal fissure) with presentation of per-anal bleeding 4.Patients with history of > 3 recurrences of anal fissure post medical or surgical intervention.
•5.Patients on oral calcium channel blockers or vasodilators like minoxidil, hydralazine or alprostadil.
•6.Patients who have a history of topical therapy with nitroglycerine/ lignocaine/ steroids/ calcium channel blockers in the past one month.
•7.Patients who are pregnant or lactating.
•8.Patients with history of life threatening cardiovascular and /or neurological event in the past one year.
•9.Patients with auto-immune disease, uncontrolled hypertension, uncontrolled diabetes mellitus(requiring change in antidiabetic therapy every 3 months) and chronic severe respiratory disease.
•10.Patients with documented evidence of renal function tests > 1 and a half times of normal reference range at baseline visit 11.Patients withdocumented evidence of liver function tests > 2 and a half times of normal reference rangeat baseline visit 12.Patients with history of HIV/HBV/HCV infection in the past.
•13.Patients on herbaceutical medication since the last 3 months.
•14.Patient allergic to any of the ingredients of trial drug or the comparator drug 15.Patients currently participating in another clinical trial for any indication or has participated in any clinical trial in the last 30 days.
•16.Patient not willing to sign on the informed consent document or not willing to come for follow-up visits.