An Open Labeled, Single Centre, Prospective, Clinical Study to Evaluate Efficacy and Safety of ARWL12 Capsule in Patients suffering from Internal Hemorrhoids
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- 1. Proportion of subjects achieving cessation of per rectal bleeding at the end of the treatment
研究概览
简要总结
This is an open labeled,single centre, prospective, clinical study to evaluate efficacy and safety ofARWL12 capsule in patients suffering from Internal Hemorrhoids. Subjects willbe advised to take 2 capsules twice daily after meals for 60 days. The studywill be carried out in Government Ayurved College and Hospital, Vazirabad,Nanded, India. The study will be carried out in 38 patients of InternalHemorrhoids. Primary objectives will be to observe proportion of subjectsachieving cessation of per rectal bleeding at the end of the treatment and posttreatment reduction in severity of bleeding per rectum. Secondary objectiveswill be to observe post treatment reduction in pile mass, post treatmentreduction in other symptoms of hemorrhoids, improvement in Quality of Life atthe end of the treatment, Global assessment for overall improvement by patientat the end of the treatment, Global assessment for overall improvement byphysician at the end of the treatment and assessment of pre and post treatmentchanges in laboratory investigations like Liver function tests (LFT), Renalfunction tests (RFT), Lipid profile, Complete Blood Count (CBC), ESR, UrineExamination, Stool Examination and ECG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Literate males or non-pregnant females, aged 20 to 60 years (both inclusive).
- •2.Symptomatic internal hemorrhoids, Grades I & II by direct proctoscopic visualization 3.Bleeding from hemorrhoids for at least two days prior to randomization 4.Body mass index of ≥ 18.5 to ≤ 36 kg/m
- •5.Subjects of female gender or non-pregnant, non-lactating females, at least six weeks postpartum.
- •A urine pregnancy test is required for all female subjects unless subject has had a hysterectomy, tubal ligation, or is > 2 years postmenopausal.
- •6.Females of child bearing potential who agree to use contraception.
- •7.Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
排除标准
- •1.Patients with protruding or irreducible hemorrhoids (grade IV).
- •2.Patients with anal fistulas, periproctitis or hemorrhagic diathesis 3.Patients with current history of Type I or Type II diabetes mellitus.
- •4.Patients with severe hepatic, renal or cardiovascular disorders.
- •5.Patients with any type of infectious disease.
- •6.Patients who have been involved with another experimental drug trial within the past 30 days.
- •7.Patients presently diagnosed with cancer.
- •8.Patients who have known alcohol and drug abuse.
- •9.Patients who require the use of suppositories.
- •10.Use of anticoagulants within 30 days prior to Day
- •11.Patients on anti-platelet agents or low dose aspirin 12.Use of over the counter or prescription anti-hemorrhoid agents (allopathic, herbal, homeopathic, Unani, Siddha medicines) within 14 days prior to Day
- •13.Patients with blood or urine laboratory values outside the normal limits or those with values considered abnormal in the opinion of the investigator.
- •14.Known hypersensitivity to ingredients used in study drug 15.Pregnant and Lactating females.
结局指标
主要结局
1. Proportion of subjects achieving cessation of per rectal bleeding at the end of the treatment
时间窗: 2 months
2. Post treatment reduction in severity of bleeding per rectum
时间窗: 2 months
次要结局
- 1.Post treatment reduction in pile mass(2.Post treatment reduction in other symptoms of hemorrhoids)