A Randomized Controlled Clinical study to evaluate the efficacy of Durvadi Tailam Suppository in the management of Anal Pain in Parikartika in Young adults with special reference to Anal Fissure. - NI

Dr SHATTARKA G MAHADIK0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年10月16日

试验速览

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•1.Patients presenting with anal pain and two or more other complaints like bleeding per rectum, painful defecation, constipation and pruritis for a duration of = 6 months.
•2.Patients clinically diagnosed of having Acute and Chronic Anal Fissure for a duration of = 6 months presenting with anal pain and two or more other complaints like bleeding per rectum, painful defecation, constipation and pruritis.
•3.Patients of either sex will be included.
•4.Age 18-60 years old patients included.
•5.Patients ready to give informed written consent.
•6.Patients ready to abide by the trail procedures meant for this study.

•1.Known cases or suspected cases Irritable Bowel Diseases- Ulcerative diseases and Chron’s diseases.
•2.Patients below 18 years and above 60 years of age.
•3.Patients with known cases of other Anal conditions like Inflamed or infected Sentinel pile (External tag), Hemorrhoids, Fistula in Ano, Abscess, Proctitis, Malignancy, etc.
•4. Patients with following medical conditions requiring stringent medications like
•o Hematological conditions- Anemia, thrombocytopenia and bleeding disorders. Poorly controlled hypertension ( >160/100 mm Hg)
•o Uncontrolled diabetes mellitus having hemoglobin A1c (HbA1c) > 8%
•o With concurrent serious hepatic disorders (defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2 times upper normal limit)
•o With Renal disorders (defined as serum creatinine > 1.2 mg/dL),
•o With severe pulmonary dysfunction (uncontrolled bronchial asthma and/or chronic obstructive pulmonary disease (COPD))
•o Acute and generalized spreading infections
•o With Immunocompromised status.
•5. Patients on medication with corticosteroids, phototherapy, radiotherapy, chemotherapy, biologics, antidepressants, and any other drugs that may have an influence on the outcome of the study.
•6. Pregnant females.
•7.History of hypersensitivity to any of the trial drugs or their ingredients.

发起方

Dr SHATTARKA G MAHADIK