CTRI/2024/08/072002尚未招募Unknown
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 - NI
试验速览
- 阶段
- Unknown
- 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
- •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
研究者
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