跳至主要内容
临床试验/CTRI/2024/10/075778
CTRI/2024/10/075778尚未招募不适用

A randomized controlled clinical Study to evaluate the efficacy of Gunja Ksharasutra with Apamarga Ksharasutra in the patients of Bhagandhara(Fistula-in-Ano)

S.V Ayurvedic College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Accessing the pain, discharge, itching, unit cutting time and tenderness for every week until cut open of a track. The efficacy is calculated by comparing the both subjecive and objective parameters of both ksharasutras each other.

研究概览

简要总结

Bhagandhara can be compared with Fistula-in-ano in terms of clinical features and treatment. The word fistula is derived from the Latin word a Reed, pipe, or flute. It implies a chronic granulating Track connecting two epithelial-lined surfaces. These Surfaces may be cutaneous or mucosal. The main Cause known for fistula-in-ano is a crypto glandular Infection of anal crypts. The anal fistula is a single Track with an external opening in the skin of the peri- Anal region and an internal opening in the modified Skin or mucosa of the anal canal or rectum. Various operative procedures often lead to complications like recurrence, Anal incontinence, infections, etc. The prevalence rate is 8.6 cases per 1000 population. The male-to-female ratio is about 1.8:1. It is categorized as a surgical domain which still to date is where surgeons have been struggling for centuries with its incurable with recurrence rate of 30%-40%.

Acharya Sushruta described Bhaishajya chikitsa, Kshara karma, Agni Karma, and Shastra Karma chikitsa for anorectal Diseases. Kshara karma comes under anusastra which is defined as hina sastra (sub-surgical condition) or shaly sadrusya(similar to a surgical instrument), used like a surgical instruments but with lesser invasion and stress on the patients. Bhagandara is a Chedya (excision) vyadhi. The Ksharasutra is a Para-surgical measure capable to perform excision slowly by virtue of its mechanical pressure and chemical action in Bhagandara because the kshara possesses the qualities of chedana, bhedana, lekana, and tridoshahara.

kshara sutra is mentioned in the textual references of Chakradatta and Rasatarangini where we get only indication of a thread made up of snuhi, apamarga and haridra. Acharya Susrutha mentioned 23 types of plants useful for kshara karma (sus. su 11/11) like gunja, palasha, kutaja, and Gunja14.

Need for the study:

Kshara sutra is a successful novel drug delivery system in managing the cases of fistula-in ano but it has certain clinical problems like Pain, Burning sensation, Inflammation, duration for the complete cutting of the track anf finally complete healing time.

Scope of the study:

Gunja has tridoshahara properties which will works on all the doshas and helps to minimize adverse effects like inflammation, itching, burning sensation, pain and thereby decreases uct (unit cutting time) followed by fast healing of the wound. Gunja plant available in all seasons, it can be cultivated easily and economically. This study helps to develop a alternate standard Gunja kshara sutra along with Apamarga kshara sutra.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)

入选标准

  • Patients irrespective of Gender and religion from the age group of 20 to 60 years.
  • Patients Patients with signs and symptoms of Bhagandhara.
  • Patients who are diagnosed as Fistula-in-ano.

排除标准

  • Concomitant Ano-rectal conditions like ulcerative colitis, malignancy, Crohn’s disease, multiple fistulae.
  • Tuberculosis.
  • Obstructive Uropathies.
  • • Systemic diseases like CAD, Portal hypertension.
  • • Patients with controlled blood sugars.

结局指标

主要结局

Accessing the pain, discharge, itching, unit cutting time and tenderness for every week until cut open of a track. The efficacy is calculated by comparing the both subjecive and objective parameters of both ksharasutras each other.

时间窗: Once a week, following the replacement of an existing ksharasutra, until the entire track is cut open.

次要结局

  • Complete healing time, reoccurrences & any other complications like incontinency, discharge, etc.(After the entire track is cut open, follow up with a patient for 2 months with an interval of 15 days.)

研究者

发起方
S.V Ayurvedic College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dudekula Shareef

S.V Ayurvedic College and Hospital

研究点 (1)

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