A Prospective, Open Label, Single Center Clinical Study to Evaluate the Effectiveness and Safety of Fixed Dose Combination of Sucralfate 7% w/w, Metronidazole 1% w/w, and Lignocaine Hydrochloride 4% w/w in the Management of Postoperative Symptoms in Patients who Underwent Surgical Treatment for Anorectal Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.Proportion of patients with minimal clinically important difference (MCID) at 3 and 6 weeks after surgery where MCID is defined as reduction in 10 points on 100 mm VAS scale at 3 and 6 weeks after surgery from the baseline score
研究概览
简要总结
Various studies havereported the effectiveness and safety of Sucralfate, Metronidazole and Lignocainewhen used alone in the treatment of anorectal disorders. However, thecombination of these 3 drugs (Sucralfate, Metronidazole with LignocaineHydrochloride) would be a viable option to provide the additive effects interms of improvement in postoperative pain relief and wound healing. Hence, the current study isdesigned to evaluate the effectiveness and safety of FDC of Sucralfate 7% w/w,Metronidazole 1% w/w, and Lignocaine Hydrochloride 4% w/w (CremaGel-H byAbbott India Ltd) in terms of wound healing, postoperative pain, itching,bleeding, and burning after surgery of hemorrhoids, fistulae and anal fissures.This FDC has been approved by Drug Controller General of India for thetreatment of bedsore, hemorrhoids, fistulae, and anal fissure on 23 August 2004.
Croissance Clinical Research Pvt Ltd Hyderabad is providing Data Management support to this study.
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
- 18.00 Year(s) 至 64.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female patients above 18 up to 64 years (both inclusive) 2.Patients who are undergoing surgery of hemorrhoids, fistulae, and / or anal fissures and are willing to take CremaGel-H for their postoperative symptoms 3.Patients willing to comply with study procedures and requirements 4.Patients willing to sign and date written informed consent form (ICF) to participate in the study.
排除标准
- •1.History of inflammatory bowel disease, multiple fistulas, perianal dermatitis, proctitis, pulmonary or cardiovascular complications, or poorly controlled diabetes mellitus 2.Anal fistulas or anal fissure due to other causes such as Crohn disease, anal suppuration, and abscesses 3.Recent history (< 2 weeks) of chemotherapy 4.Diagnosis of active cancer, severe anemia, hypoalbuminemia, or immunocompromise 5.Past history of hypersensitivity to any of the ingredients of the study product, including Metronidazole, Lignocaine Hydrochloride, Sucralfate, or any other ingredient in the formulation 6.Patients on Class I anti-arrhythmic drugs or anticoagulant treatment as the toxic effects are additive and generally synergistic 7.Any past or present conditions / diseases that Investigator considers inappropriate for a patient to participate in the study 8.Patients who are unwilling to have an examination of anal wounds 9.Pregnant and lactating females.
结局指标
主要结局
1.Proportion of patients with minimal clinically important difference (MCID) at 3 and 6 weeks after surgery where MCID is defined as reduction in 10 points on 100 mm VAS scale at 3 and 6 weeks after surgery from the baseline score
时间窗: at baseline, Week 3 and Week 6
2. 2.Mean reduction in anal pain (on 100 mm VAS score) from baseline
时间窗: at baseline, Week 3 and Week 6
次要结局
- Proportion of patients with complete wound healing(at 3 and 6 weeks after surgery)
- Mean reduction in •Itching on a 5-point scale ranging from score 1 (not present) to score 5 (unbearable)(from baseline to 3 and 6 weeks after surgery)
- Mean reduction in Bleeding score on a 5 point scale ranging from 1 episode per 2 weeks to 5 bleeding episodes per week(from baseline to 3 and 6 weeks after surgery)
- Mean reduction in •Burning on a 4 point scale ranging from score 0 (no symptoms) to score 3 (severe intensity symptoms)(from baseline to 3 and 6 weeks after surgery)