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
- 30
- 试验地点
- 2
- 主要终点
- Healing of Anal Fissure
研究概览
简要总结
Anal fissure is a tear occurring in the anal canal, beginning from the dentate line and
extending up to the anal verge.
They are characterised symptomatically by pain during or after defecation, anal bleeding
and spasms of the anal sphincter.
Anal fissures are equally seen in both males and females. It is most commonly seen in the
middle aged and the young patients, with the mean age of onset being 39.9 years.
The anal fissures have been classified arbitrarily as acute and chronic anal fissures, based
on the duration of the presenting symptoms.
Patients with symptoms for less than 6 weeks in duration are considered to be suffering
from acute anal fissure.
The non-operative treatment options for cases of anal fissures are sitz bath, local
anaesthetics, topical nitrates, oral intake of fibre, laxatives and topical or oral calcium
channel blockers.
Patients of chronic anal fissures with long term symptoms may be taken up for surgery
which carries an important complication of anal incontinence.
Thus, there is a need of new treatment modalities for relief in the patients with anal
fissure with minimum side- effects.
The Study is multi-centric,prospective, phase 4 trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
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.
- •Patients with a composite score of > 4 at baseline visit.
排除标准
- •Patients having anal fistulas or anal fissure of various causes such as Crohn’s disease, anal suppuration, abscesses (Secondary underlying causes).
- •Patients having anal or perianal malignancy.
- •Patients with diagnosis of any illness (other than anal fissure) with presentation of per-anal bleeding
- •Patients with history of > 3 recurrences of anal fissure post medical or surgical intervention.
- •Patients on oral calcium channel blockers or vasodilators like minoxidil, hydralazine or alprostadil.
- •Patients who have a history of topical therapy with nitroglycerine/ lignocaine/ steroids/ calcium channel blockers in the past one month.
- •Patients who are pregnant or lactating.
- •Patients with history of life threatening cardiovascular and /or neurological event in the past one year.
- •Patients with auto-immune disease, uncontrolled hypertension, uncontrolled diabetes mellitus(requiring change in antidiabetic therapy every 3 months) and chronic severe respiratory disease.
- •Patients with documented evidence of renal function tests > 1 and a half times of normal reference range at baseline visit.
- •Patients withdocumented evidence of liver function tests > 2 and a half times of normal reference range at baseline visit.
- •Patients with history of HIV/HBV/HCV infection in the past.
- •Patients on herbaceutical medication since the last 3 months.
- •Patient allergic to any of the ingredients of trial drug or the comparator drug.
- •Patients currently participating in another clinical trial for any indication or has participated in any clinical trial in the last 30 days.
结局指标
主要结局
Healing of Anal Fissure
时间窗: 6 Week
次要结局
- Relive from Constipation and Hard stool(6 weeks)