Comparative clinical study on the effect of modified Apamarga Kshaarasutra and standard Apamarga Kshaarasutra in the management of Bhagandara (fistula-in-ano)
试验速览
- 阶段
- 3 期
- 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 of Fistulous tract
研究概览
简要总结
Bhagandara is second common disease occurring in ano-rectal region after haemorrhoids. The prevalence rate of fistula-in-ano is 8.6 cases per 1 lakh population. The prevalence in men is 12.3 and in women is 5.6 cases per 1 lakh population. The male-to-female ratio is 1.8:1. The mean age of participants is 38.3 years. It is considered as one among the Mahagada in Sushruta Samhita. In Ayurveda Kshaarasutra application is well known for management of Bhagandara.
Advantages of Kshaara Sutra Therapy**:** Simple and safe parasurgical procedure, cost-effective and ambulatory, minimal recurrence rate, no surgical complications like incontinence, stenosis and stricture. Snuhi Ksheera based Apamarga Kshaarasutra is the standard one and is proved effective treatment in the management of Fistula-in-ano. Delays in unit cutting time of the fistulous tract and difficulty of manufacturing process has limited its use.
At present Apamarga Kshaarasutra is prepared by giving 11 coatings of Snuhi ksheer, 7 coatings of Snuhi and Apamarga Kshaara and 3 coatings of Snuhi and Haridra which takes a total of 21 days for preparation of the Standard Apamarga Kshaarasutra. In the current study,
PROBLEMS-
Collection of raw material – Collecting Snuhi Ksheer for 21 days is a problem for a practicing Doctor and its less availability.
Weakening of Kshaara Sutra – As the day increases the thread used for Kshaara Sutra (tensile strength of thread)gets weak day by day hence I am trying to keep the strength of thread as stronger as possible which will reduce the changing time for participants also and benefits them in the way pain of Kshaara Sutra changing and reduces the financial load to participants.
To overcome these problems, I have adopted the study of Modified Kshaara Sutra in the management of Bhagandhara
SOLUTIONS
As the modified Kshaara Sutra is less exposed to heat and its tensile strength is preserved it may decrease the unit cutting time.
Which will be beneficial to participants in the manner of frequent pain of Kshaara Sutra changing and financially also
Apamarga Kshaarasutra is prepared out of 11 coatings of Snuhi ksheer, 3 coatings of Snuhi Apamarga Kshaara and 3 coatings of Snuhi and Haridra, so a total of 21 coatings will be given.This study has been intended to evaluate whether 21 coatings in 7 days of modified Kshaara sutra is effective in comparison to standard Apamarga Kshaarasutra in terms of decreased time period of preparation and to assess the unit cutting time.
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 Recurrent Fistula- in-ano Fistula- in-ano with Perineal abscess Participants who give written surgical consent Participants fit for surgery Participants above the age of 18 years and below 60 years irrespective of caste, gender, religion and socio-economic status.
排除标准
- •Participants with secondary fistula due to Ulcerative colitis, Crohn’s disease, Tuberculosis, Hidradenitis Suppurativa, Carcinoma of rectum& anal canal Participants with HIV and HBsAg positive participants Pregnancy and lactating women Participants with impaired cardiac, renal and hepatic function.
结局指标
主要结局
Unit cutting of Fistulous tract
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, granulation tissue, size of wound(assessment will be done at baseline followed by weekly assessment until the fistula tract is completely healed.)