The efficacy of Pratisaraniyakshara in the management of Abhyantara arsa Arsa(second degree hemorrhoids)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- 1.Change in Hemorrhoid Severity Score (HSS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of second degree piles Willing and able to give written informed consent.
排除标准
- •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.
结局指标
主要结局
1.Change in Hemorrhoid Severity Score (HSS)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
次要结局
- 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)
研究者
Dr Indu P P
NARIP Cheruthuruthy