Health Condition 1: K928- Other specified diseases of the digestive system
Conditions
Interventions
None listed
Sponsors
CCRAS
Eligibility
Inclusion criteria
Inclusion criteria: A patient diagnosed with first and second degree according to Goligher Classification haemorrhoids presenting with rectal bleeding confirmed by Proctoscopy at least 2 weeks but not exceeding 12 months duration. Active rectal bleeding with or without associated symptoms such as pain or itching at least 2 weeks but not exceeding 12 months. Willing to provide a written informed consent agreement to comply with the follow-up schedule and treatment protocol.
Exclusion criteria
Exclusion criteria: Patients with comorbidities such as Fistula in Ano Perianal abscess clinically evident fecal incontinence and anal stenosis or fibrosis Known case of inflammatory bowel disease tuberculosis and thrombosed and strangulated pile mass or hemorrhoids Known case of bleeding diathesis Patients with evidence of malignancy Patients with uncontrolled hypertension clinically evident renal disease hepatic disease cardiovascular disease and psychiatric disorders Patients with estimated glomerular filtration rate less than eighty nine milliliters per minute per one point seven three square meters as calculated using the twenty twenty one CKD EPI creatinine equation Male patients with SGOT or AST levels greater than or equal to seventy Units per Liter and female patients with SGOT or AST levels greater than or equal to sixty two Units per Liter which are more than two times the Upper Limit of Normal ULN Male patients with SGPT or ALT levels greater than or equal to ninety Units per Liter and female patients with SGPT or ALT levels greater than or equal to sixty eight Units per Liter which are more than two times the Upper Limit of Normal ULN Patients on prolonged more than six weeks medication with corticosteroid antidepressant anticholinergic immunosuppressant estrogen replacement therapy antiplatelet therapy such as aspirin and other drugs that may influence the study outcome Patient hemodynamically unstable or significant anaemia Symptomatic patient with clinical evidence of heart failure or on blood thinner medication Patients suffering from major systemic illness necessitating long term drugs Patients having uncontrolled Diabetes Mellitus HbA1c more than eight percent Pregnant or lactating females Alcoholics and drug abusers History of hypersensitivity to any of the trial drugs or their ingredients Patients who have completed participation in any other clinical trial during the past six months Any other condition that the Investigator thinks may jeopardize the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes are Proportion of participants achieving cessation of active bleeding for at least 24 consecutive hours within a defined time frame of 10 days following treatment initiationTimepoint: 10 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to cessation of bleeding Time frame is 7th & 10th day.Timepoint: Time frame is 7th & 10th day;Change in QoL scores from baseline to end of treatment using a validated HDSS haemorrhoid disease symptom score instrument.Timepoint: baseline 7th 11th 30th 60th & 90th day;The proportion of subjects having bleeding or symptom relapse post treatment.Timepoint: 30th 60th & 90th day;Change in pain scores measured by the Visual Analogue Scale VAS from baseline to end of treatment.Timepoint: baseline 7th & 11th day;Incidence of adverse events during the study period. Time frame is 90 daysTimepoint: Time frame is 90 days | — |
Countries
India
Contacts
Public ContactHemanta Panigrahi
CCRAS-CARI Ministry of Ayush Govt of India
Outcome results
None listed