CTRI/2020/11/029129已完成4 期
An Open Labelled phase 4 Single Group Proof-of-concept study to evaluate theEfficacy & Safety of Arshkeyt, a 7 day kit in patients suffering from Analfissures.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
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
- •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 Crohn’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
- •11. Patients withdocumented evidence of liver function tests
- •> 2 and a half times of normal reference range at baseline
- •12. Patients with history of HIV/HBV/HCV infection in the
- •13. Patients on herbaceutical medication since the last 3
- •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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