CTRI/2020/02/023229尚未招募2 期
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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Adult patients aged between 18 - 60 years of either sex.
- •2. Patients with a confirmed diagnosis of anal fissure
- •3. 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.
- •4. 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
研究者
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