The efficacy of Pratisaraniyakshara in the management of Abhyantara arsa Arsa(second degree hemorrhoids)
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- 1.Change in Hemorrhoid Severity Score (HSS)
Study Overview
Brief Summary
The study will be conducted in two phases. Phase one includes clinical consensus study for the SOP development of kshara nirmana and the pratisaraneeya kshara nirmana as per the developed SOP . In the second phase is clinical study for the efficasy of ksharakarma in the management of abhyantara arsa. ksharakarma will be done as per the SOP developed using the kshara prepared as per the SOP. sample size for the study is 75 and total duration is 112 days which includes 21 days of treatment period.Total trial duration is three yeras.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of second degree piles Willing and able to give written informed consent.
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.
Outcomes
Primary Outcomes
1.Change in Hemorrhoid Severity Score (HSS)
Time Frame: 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)
2.To assess the recovery time
Time Frame: 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)
3.Changes in colour of pile mass and assess post operative discharge
Time Frame: 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)
4.To assess the post operative complications like bleeding, pain, infection, stricture, incontinence
Time Frame: 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 Outcomes
- 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)
Investigators
Dr Indu P P
NARIP Cheruthuruthy