A Comparative Clinical Study On The Effect Of Kutaja Kshara Sutra And Apamarga Kshara Sutra In The Management Of Bhagandara (Fistula-In-Ano)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- unit cutting time of fistulous track
研究概览
简要总结
Bhagandara is the second common disease occurring in ano-rectal regionafter Arshas. The prevalence rate of fistula-in-ano is8.6 cases per1lakh population.Estimatessuggest that it affects approximately 0.05% to 0.1%of the general population in India. The prevalence in men is 12.3 casesper 1 lakh population and in women is 5.6 cases per 1 lakh population. Themale-to-female ratio is 1.8:1. The mean age of participants is 38.3 years. Itis considered as one among the
Mahagada in Sushruta Samhita.
In AyurvedaKshara Sutra application is well known in the management of Bhagandara. Advantagesof KsharaSutra Therapy**:** Simple and safeparasurgical procedure,cost-effective and ambulatory, minimal recurrence rate,no surgical complications like incontinence, stenosis and stricture..
Atpresent Apamarga Ksharasutra is prepared by giving 11coatings of SnuhiKsheera,7coatings of Snuhi and Apamarga Kshara and 3 coatings ofSnuhiandHaridrawhichtakesatotalof21daysforpreparation of the Apamarga Kshara Sutra.
AcharyaSusruta ,while describing the process of Kshara extraction in sutrasthana chapter-11has mentioned 23 drugs and Kutaja is first and foremost drug. Acharya Sushrutain the 17th chapter of SushrutaChikitsaSthanahasadvocatedtheKsharaSutraanditsapplication.Chakrapanidattahasdescribed the preparation of Kshara Sutra by smearing the latex of Snuhi,Kshara and Haridra repeatedly.
Inthe current study the potential synergistic effect of comparing Apamarga KsharaSutra, known for its healing qualities of the fistulous tract but its demeritssuch as irritation and burning sensation during primary and successive changesand also local skin irritation occurs during course of therapy and it is only Kaphahara to overcome these with Kutaja Kshara Sutra, where Kutaja possesses qualities like Kaphapitta Doshahara and has Sheeta Virya, which merit further studyto assess the potential of Kutaja KsharaSutra against the demerits of ApamargaKshara Sutra.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinical signs and symptoms of all types of Bhagandara Fistula- in-ano with Perianal abscess Participants who give written surgical consent Participants fit for surgery Participants above the age of 18 years and below 60years irrespective of caste,gender, religion and socio-economic status.
排除标准
- •Participants with secondary f istula due to Ulcerative colitis, Crohns disease,Tuberculosis, Hidradenitis Suppurativa, Carcinoma of rectum& anal canal ,condyloma acuminata,condyloma lata Participants with HBsAg and retro positive participants.
- •Pregnancy and lactating women.
- •Participants with impaired cardiac, renal and hepatic function.
结局指标
主要结局
unit cutting time of fistulous track
时间窗: assessment will be done at baseline, followed by weekly assessment until the fistula tract is completely healed
次要结局
- pain(discharge)