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临床试验/CTRI/2024/10/075458
CTRI/2024/10/075458尚未招募不适用

A Randomized Controlled clinical study of Katutumbi bijadi Guda varti with Apamarga Ksharasutra Ligation in the patients of Arshas(II and III Degree Haemorrhoids)

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10月30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
To find out whether this study drug regress the size of Arshas and prevents the recurrence of Arshas.

研究概览

简要总结

In Ayurveda, since Vedic period Arshas has been the main area of concern among anorectal disease. The great Indian Surgeon Susrutha known as father of surgery has described Arshas in Susrutha samhitha Nidana sthana 2 nd chapter (K.R..Srikantha Murthy,2017, p.233) and its chikitsa in Chikitsa sthana 6th chapter. He considered Arshas as one of the Astha Mahagadas means diseases which are very difficult to treat. Arshas is an torious for its troublesome pain like enemy, which afflicting mankind for thousands of years.

This condition can be correlated with Haemorrhoids in modern science, in which dilated veins within the anal canal in the sub-epithelial region formed by radicals of superior, middle and inferior rectal veins. Haemorrhoids are engorgement of the Haemorrhoidal venous plexus, characterized by bleeding per rectum, constipation, pain, prolapse and discharge.

Acharya Susrutha has mainly narrated the four types of treatment modalities for successful management of Arshas viz., Bhesaja [Internal and external medications], Shastra [Surgical methods], Kshara [Caustic cauterization], and Agnikarma [Thermal cauterization].

Despite of many more modern treatments like Rubber band ligation, Sclerotherapy, Photocoagulation, Cryosurgery, Haemorrhoidectomy, etc., Ayurveda is well known for the treatment of Arshas for its negligible rate of recurrence, cost effective, less chances of pain, Haemorrhage, infection and anal incontinence.

According to Bhaisajya ratnavali, only three applications of Gudavarti prepared by pounding Tumbi bija and Audbhida lavana with kanji alleviate Arshas. During the course of treatment, the patient is to be kept on Buffalo’s curd diet.

Gudavarti are solid dosage preparations which are prepared by moulding or compression methods intended for its insertion into rectum. It facilitates vata anulomana and which there by eases the expulsion of Mala and also intended to exhibit udavarthahara karma. Katutumbi beeja is having katu vipaka and which has anti-thrombotic property makes bandana of sonitha srava. Because of having tikta rasa it acts on tvak and mamsa dhatu makes mamsa sthirikarana which may prevents degenerative process in collagen fibers and fibro-elastic tissue. That which may help’s in reducing the congestion and pooling of blood from the hamorrhoidal masses and increases the tone of vasculature so that mass start decreasing in size gradually and in the end it may completely shrinks the mass.

There are several therapeutic reasons affecting bioavailability of drugs from rectal suppositories, one among these is to partly avoid hepatic first- pass elimination or metabolism following rectal administration. Colorectal absorption is a simple diffusion process through the lipoidal membrane in which there is carrier mediated mechanism. It is also believed that rectal pH of about 7.3 provides a convenient environment for the drug to be chemically stable on insertion. No issues with oral compliance of the patient thus avoiding nausea and vomiting. It also proves to be a convenient drug delivery option in patients especially with rectal complaints. The rectal temperature ia around 37.8ºC-38.9 ºC where as the melting point of this prepared Gudavarti is 36ºC which is easly soulbe in rectal temperature and hence play a good mode of action.

Among the four treatment modalities in Arshas mentioned by susrutha, kshara karma and Agnikarma are considered as para-surgical procedures. These para-surgical procedures are having many advantages viz., They are simple, safe, effective, ambulatory and minimal or no complications, less time to study in hospital and minimal interference in patients routine work.

Ksharasutra treatment is very suitable and acceptable as compared to prevalent methods in modern medical science. Even though, it has been accepted by medical society for its good efficacy in treatment of Bhagandara there is still need in of standardization of Ksharasutra Ligation in the treatment of arshas.The Ksharasutra ligation performs excision by virtue of its mechanical pressure and phytochemical cauterization effect and ligation is expected to reduce the engorgement and finally peels the lesion in the post operative period and may prove superior to the conventional Haemorrhoidectomy.

The present study compares the efficiency of Katutumbi Bijadi Gudavarti with Apamarga Ksharasutra Ligation in the patients of  Arshas.

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 65.00 Year(s)(—)
性别
All

入选标准

  • Patients having signs and symptoms of Arshas.
  • Patients with age ranging from 18 years to 65 years with irrespective of gender.
  • Patients having II & III degree Haemorrhoids.

排除标准

  • Concomitant Ano-rectal conditions like Fistula-in-Ano, Fissure.
  • in -Ano, ulcerative colitis, Malignancy. 2)Pregnant women. 3)Patients of Portal hypertension. 4)Patients of Chronic kidney diseases. 5)Patients of Tuberculosis. 6)Patients of Inflammatory bowel disease. 7)Patients of Uncontrolled diabetes.

结局指标

主要结局

To find out whether this study drug regress the size of Arshas and prevents the recurrence of Arshas.

时间窗: 3 days

次要结局

  • To find out safe, simple, effective and economical method of treating Arshas.(1 month)

研究者

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

Tanneeru Lakshmi Gowri

S V Ayurvedic college and Hospital

研究点 (1)

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