A comparative study to evaluate the efficacy and safety of Diltiazem hydrochloride 2 percent w/w plus Lidocaine hydrochloride 2 percent w/w Gel with Lignocaine Hydrochloride Gel 2 percent w/w in anal fissure patients A Prospective Randomized Open-Label Single Centre Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To compare the efficacy of Diltiazem hydrochloride 2% w/w +Lidocaine hydrochloride 2% w/w Gel with Lignocaine Hydrochloride Gel 2% w/w
研究概览
简要总结
Anal fissure is a superficial tear in the anoderm distal to the dentate line. Anal fissures are common in those with a history of constipation or hard stools, low fibre diet, trauma, and previous anal surgery. It has been postulated that, lidocaine can provide additional benefits if added to anal dilators like diltiazem, nifedipine, GTN and minoxidil for the treatment of anal fissures. Although, there is data generated for the efficacy and safety of the Diltiazem hydrochloride 2% w/w + Lidocaine hydrochloride 2% w/w Gel with Lignocaine Hydrochloride Gel 2% w/w individually in anal fissure patients. However, it has not been compared with each other. Also, the change in mean anal resting pressure, which is the primary treatment goal in anal fissure management, after the use of the FDC has not been established. Due to the lack of this data, it is essential to understand the efficacy of the Diltiazem hydrochloride 2% w/w + Lidocaine hydrochloride 2% w/w Gel with Lignocaine Hydrochloride Gel 2% w/w
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 64.00 Year(s)（—）
- 性别
- All
入选标准
- •Males and females with age 18 to 64 years (both inclusive) with a diagnosis of anal fissure Willing to stop all other concomitant topical preparations applied peri-anally prior to commencing study treatment and throughout the study Subjects who understand the requirement of the study and is willing to sign and date written informed consent to participate in the study.
排除标准
- •Subjects unwilling to have an examination of anal fissure Subjects having anal fistulas or anal fissure of various causes such as Crohn disease anal suppuration abscesses Subjects who have or have undergone the following gastrointestinal disorders or procedures Inflammatory bowel disease chronic fecal incontinence anal abscess a history of radiation therapy to the pelvis fixed anal stenosis/fibrosis Subjects with a history of neoplastic disease within 5 years Subjects with associated acute hemorrhoidal attacks Subjects having anal or perianal cancer Subjects who have had lateral sphincterotomy or anal stretch or other previous surgery involving the anal canal or perianal region Subjects with a clinically significant history of renal hepatic neurological dermatological immunological major psychiatric (including drug or alcohol abusers) or hematological illness Subjects of hypertension / ischemic heart disease on oral calcium channel blockers Subjects with atrial fibrillation associated with other conditions Subjects with cardiovascular disease Subjects who have previously received therapy with diltiazem hydrochloride cream nitrates vasodilator or other topical calcium channel blockers Subjects with hypersensitivity to any of the ingredients in the study drug Females of childbearing potential must have a negative pregnancy test and be non-lactating Subjects who are unsuitable for any other reason to participate in the study in the opinion of the investigator.
结局指标
主要结局
To compare the efficacy of Diltiazem hydrochloride 2% w/w +Lidocaine hydrochloride 2% w/w Gel with Lignocaine Hydrochloride Gel 2% w/w
时间窗: Baseline Day 10 Day 21
次要结局
- To compare the change in Mean Resting Anal Pressure of Anal Fissure(Patients after applying Diltiazem hydrochloride 2% w/w + Lidocaine)
研究者
Dr Jaya Maheshwari
Jyoti Nursing Home