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

Dr Niranjan Agarwal0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

•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

发起方

Dr Niranjan Agarwal