Health Condition 1: K628- Other specified diseases of anus and rectum
Conditions
Interventions
None listed
Sponsors
CCRAS
Eligibility
Inclusion criteria
Inclusion criteria: Patients of second degree piles Willing and able to give written informed consent
Exclusion criteria
Exclusion criteria: Third degree ,Thrombosed & Strangulated pile mass (Hemorrhoids) Bleeding diathesis Cirrhosis of Liver- Portal hypertension Ulcerative colitis and Crohn s disease Patients with evidence of malignancy Patients on prolonged (greater 6 weeks) medication with corticosteroids, antidepressants, anticholinergic, immunosuppressant, estrogen replacement therapy etc. or any other drugs that may have an influence on the outcome of the study. Patients suffering from major systemic illness necessitating long term drug etc. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. Symptomatic patient with clinical evidence of Heart failure. Patients having uncontrolled Diabetes Mellitus (Blood Sugar Fasting greater than 250mg/dl). Patients with concurrent serious hepatic disorder (defined as aspartate aminotransferase (AST) and or alanine aminotransferase (ALT), total bilirubin or alkaline phosphatase (ALP) greater than 2 times upper normal limit) or renal disorders (defined as S.Creatinine greater than1.2mg per dL), severe pulmonary dysfunction (uncontrolled asthma and chronic obstructive pulmonary disease [COPD]), inflammatory bowel Pregnant and lactating females. Patients on oral contraceptives. Alcoholics and or drug abusers. History hypersensitivity to any of the trial drugs or their ingredients. Patients who have completed participation in any other clinical trial during the past six (06) months. Any other condition which the Investigator thinks may jeopardize the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in Hemorrhoid Severity Score (HSS) 2.To assess the recovery time 3.Changes in colour of pile mass and assess post operative discharge 4.To assess the post operative complications like bleeding, pain, infection, stricture, incontinence Timepoint: 1.(baseline, 1st week,2nd week 3rd week , 8th week ,12th week and 16th week) 2.(1st week,2nd week 3rd week , 8th week ,12th week and 16th week) 3.(baseline, 1st week,2nd week 3rd week , 8th week ,12th week and 16th week ) 4.(baseline, 1st week,2nd week 3rd week , 8th week ,12th week and 16th week) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Assessment of safety by the incidence of reported treatment emergent adverse event 2.Assessment of the tolerability of the kshara karma through reported incidence of adverse events during the study period time frame Change in the laboratory safety parameters from baseline Change in the need of Rescue analgesic medication Patient satisfaction assessment Timepoint: 1.baseline, 7th day, 14th day 21st day 2.baseline, 7th day, 14th day, 21st day & 56th ,84th&112th day 3. base line and 112th day 4.baseline, 7th day, 14th day 21st day ,56th ,84th 112th day 5.7th day, 14th day 21st day, 56th ,84th &112th112th day | — |
Countries
India
Contacts
Public ContactDr Indu P P
NARIP Cheruthuruthy
Outcome results
None listed