An open label double arm comparative clinical study to assess the effect of anal infiltration with Samamgadi Ropaṇa Taila and Murivenna in Acute Fissure- in -Ano
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Subjective Parameters
研究概览
简要总结
Fissure-in-Ano is a longitudinal split in the anoderm of the distal anal canal, which extends from the anal verge proximally towards, but not beyond the dentate line. It can be acute or chronic.Fissure -in-Ano are considered to be acute if they have been present for less than 6 weeks.Acute type of fissure gets healed by conservative management.In acute conditions,Pain and constant internal sphincter spasm which results in delay in wound healing.Delay in wound healing will lead to the chronicity of the diseases leaving only surgical options.At times surgical treatments may restrict the quality of life of the patient and productive days.
Specific medicine intending healthy granulation of the wound in Acute Fissure-in-Ano is taken into consideration.Simple formulations with easily available medicine and feasible method of local administration as an OPD Procedure which can give considerable result.Vrana ropana drugs which are easily available,easy to store and administer,cost effective and quick acting and that which yield good result will be ideal.In Samamgadi Ropana Taila phalasruti it is mentioned that "tailam ropanamuttamam".From the previous studies,Murivenna leads to re epithelialization of the wound.Wound healing,analgesics and anti-inflammatory activities of drugs has been taken into consideration.So the study is intended to assess the efficacy of anal infiltration of Samamgadi ropana Taila in comparison with Murivenna.
Aim of the study is to test the efficacy of Anal infiltration of Samangadi Ropana Taila in comparison with Murivenna in conditions of wound Healing in Acute Fissure in Ano.With the help of the above properties of the drugs,Anal infiltration can be done by using Samamgadi Ropana Taila in one group of patients and Murivenna anal infiltration in other group of patients and the comparative effectiveness will be noted.
In this study,30 patients irrespective of sex,with age limit of 20-40 years,satisfying the inclusion criteria will be recruited.The assessment will be done for duration and severity of pain,constipation,bleeding ,healing of wound and sphincter tone on 0th day,7th day,14th day,and 28th day.Wilcoxon signed rank test and Mann Whitney U Test will be used for statistical analysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Patient clinically diagnosed with Acute Fissure-in-Ano.
- •Irrespective of gender and socio-economic status.
- •Age between 20-40.
排除标准
- •1.Chronic Fissure -in -Ano with Sentinal Tag 2.Congenital diseases of anal canal.
- •3.Patient with systemic diseases like heart diseases, DM, Carcinoma, HIV, TB, IBS, Syphilis, Crohn’s diseases.
结局指标
主要结局
Subjective Parameters
时间窗: The assessments will be done on 0th day, 7th day, 14th | day, and 28th day.
1)Pain
时间窗: The assessments will be done on 0th day, 7th day, 14th | day, and 28th day.
2)Constipation
时间窗: The assessments will be done on 0th day, 7th day, 14th | day, and 28th day.
3)Bleeding
时间窗: The assessments will be done on 0th day, 7th day, 14th | day, and 28th day.
Objective Parameters
时间窗: The assessments will be done on 0th day, 7th day, 14th | day, and 28th day.
1)Healing Of Wound
时间窗: The assessments will be done on 0th day, 7th day, 14th | day, and 28th day.
2)Sphincter Tone
时间窗: The assessments will be done on 0th day, 7th day, 14th | day, and 28th day.
次要结局
- 1)Healing Of Wound(2)Sphincter Tone)
研究者
Dr Aparna Thilak
Amrita School Of Ayurveda,Amrita Vishwa Vidyapeetham
