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临床试验/CTRI/2024/10/074658
CTRI/2024/10/074658尚未招募3 期

Comparative clinical study on the effect of madhu based tankana ksharasutra and standard apamarga ksharasutra in bhagandara( fistula in ano)

Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月13日最近更新:

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 Time of Fistulous Track

研究概览

简要总结

Bhagandara is second common disease occurring in ano-rectal region after haemorrhoids. The word Fistula is derived from a Latin word reed, pipe or flute. It implies a chronic granulation track connecting two epithelial lined surfaces. 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 patients is 38.3 years. It is considered as one among the Mahagada in Sushruta Samhita. In Ayurveda Ksharasutra application is well known for management of Bhagandara.

Though in this disease many Ksharasutras tried, Apamarga Ksharasutra is widely being practiced.  When go through the classics we get reference regarding  Tankana grouped into Kshara Dravyas. This Tankana is not widely practiced. Apamarga is very effective but preparation of this Apamarga  Kshara is not at all easy process. It needs burning of lots of Apamarga plants,then processing including boiling etc, and the end we get a little quantity of final product. In other hand Tankana, as per reference, is also a Kshara, cost effective and abundantly available. It minimizing the problems like burning sensation, local irritation during the course of therapy.

Madhu has Vranaropaka properties as per the principles of the sixty Upakramas of Vrana management described in Susrutha Samhitha . The authors like Chakrapani, Susruta, Bhavaprakasha, Vangasena and Yogaratnakara have described the qualities of Madhu as Vranashodhana, Vranaropana, Lekhana, Sandhana, Varnya, Srotovishodana, Yogavahi..

Advantages of Kshara 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 ksharasutra is the standard one and is proved effective treatment in the management of Fistula-in-ano. But, burning sensation, local irritation during the course of therapy and difficulty of manufacturing process has limited its use.

To overcome these problems, I have taken the study of Madhu based Tankana Kshara sutra for better action, availability and acceptability. Madhu based Tankana Kshara sutra will be prepared by the same method as that of Snuhi Apamarga Kshara Sutra. So, the present study has been taken up to know the efficacy of Madhu based Tankana Kshara Sutra in the management of Bhagandhara.

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
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Clinical signs and symptoms of all types of Bhagandara 2.Recurrent Fistula- in-ano 3.Patients who give written surgical consent 4.Patients fit for surgery 5.Patients above the age of 18 years and below 60 years irrespective of caste, gender, religion and socio-economic status.

排除标准

  • 1.Patients with secondary fistula due to Ulcerative colitis, Crohns disease, Tuberculosis, Hidradenitis Suppurativa, Carcinoma of rectum& anal canal 2.Patients with Retro and HBsAg positive 3.Pregnancy and lactating women 4.Patients 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 completly healed

次要结局

  • Pain(Discharge)

研究者

发起方
Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Ancitta Jose

Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan

研究点 (1)

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