Randomized Controlled Clinical Trial To Study The Efficacy Of Ashwagandahdi Malhar In The Management Of Parikartika With Special Refrence To Fissure In Ano
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Reduce The Sign And Symptoms of Fissure In Ano.
研究概览
简要总结
Objective
1.Primary Objective
To study the efficacy of ashwagandhadi malahar in Parikartika with special Reference to Fssure In Ano in comparision with shatdhout ghrut.
2.SecondaryObjective
1.To study Parikartika in details as per Ayurvedic concept.
2.To study Fssure In Ano in details according to modern aspect.
3.To study the effect of trial drug i.e ashwangandhadi malahar and Shatdhautghrut.
PARTICIPANTS
120 Adults diagnosed with fissure in ano meeting inclusion and exclusion criteria from OPD and IPD of department of shalyatantra of Shree Saptashrungi Medical College and Hospital Nashik Interventions 60 patients ashwagandhadi malahar: Administered according to standardized protocol. 60 patients shatdhout ghrut. : Administered according to standardized protocol.
Primary Outcome : Reduce the sign and symptoms of fissure in ano Secondary Outcome: No recurrency of fissure in ano Treatment Duration : 7Days Follow Up :3rd , 5th , 7th Days Data Analysis : Data will be analysed using appropriate statistical methods to compare the effectiveness of the intervension on the primary and secondary outcomes.
Ethical Considerations : The study will be conducted in accordence with ethical guidelines and with informed consent from participents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having symptoms of parikartik (kartanvatvedana,daha,raktastrava,kandu) 2)Patients irrespective of sex, religion, occupation & economic status.
- •Patients between the age group of 18 to 60 years.
- •Patients which agreed for treatment with written consent.
排除标准
- •Age less than 18 years and more than 60 years.
- •Patients having Parikartika (Fissure-in-ano) secondary to Ulcerativecolitis, Syphilis, crohn’s disease, Tuberculosis and Ca of rectumand anal canal.
- •Patients with infectious diseases like HIV/HbsAg/HCV.
- •Patient having HB percentage less than 7 5)Patient with uncontrolled Diabetes and Hypertension.
- •Patients associated with conditions like Hemorrhoids (Arsha), Fistulain-ano (Bhagandar).
- •Patients with Perianal abscess, rectal prolapsed and severe local sepsis 8)Immunocompromised patient 9)Any previous anal surgery.
- •Not willing to give consent.
结局指标
主要结局
Reduce The Sign And Symptoms of Fissure In Ano.
时间窗: 7 Days
次要结局
- To Reduce The Reccurency Of Fissure In Ano(21 Days)
研究者
Dr Bipul Durgaprasad Jarare
Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashi