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临床试验/CTRI/2025/06/089255
CTRI/2025/06/089255尚未招募4 期

A controlled clinical study to evaluate the efficacy of Yava Kshara Sutra Trans-ligation in the management of Arshas (3rd & 4th degree Haemorrhoids)

Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital Koppal1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月7日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To evaluate the efficacy of Yava Kshara Sutra in terms of days taken by kshara sutra to slough out the pile mass

研究概览

简要总结

Hemorrhoids are the pedicle like lesions formed by dilated radicles of the superior, middle and inferior rectal veins in the subepithelial region of the anal canal. Internal Haemorrhoids occur within the anal canal and External Hemorrhoids are situated outside the anal orifice. These even co-exist as Interno-External Haemorrhoids. 1

The incidence of this disease is showing augmentation with advancing age equally in both males and females. At least 50% of the people over the age of 50 years have some degree of symptoms related to hemorrhoids.3 The prevalence rate of piles is 4.4% in the world, in about 10 million people. Haemorrhoids may occur at any age but mostly seen in the age between 30 to 65 years.4

According to prolapse haemorrhoids are classified into 4 degrees wherein 3rd degree haemorrhoids come out during defecation and do not return by themselves but need to be placed back manually and 4th degree haemorrhoids are permanently prolapsed and are characterized by a great deal of discomfort and heaviness in the rectum. Bleeding, prolapse, pain, discharge and anaemia are the common clinical features. 5

Modern therapeutic management for 3rd & 4th degree Hemorrhoids includes Lord’s dilatation, Cryosurgery, Infra-red coagulation, laser therapy, DGHAL (Doppler Guided Hemorrhoidal Artery Ligation), open-Haemorrhoidectomy, closed-haemorrhoidectomy, and Stapled Haemorrhoidopexy 6 which have their own disadvantages such as starting of profuse watery discharge within 3 hours of Cryosurgery which lasts upto 3 to 4 weeks, significant incidences of incontinence in elderly after Anal dilatation, marked stenosis of anal canal after complete removal of haemorrhoidal mass during Closed Haemorrhoidectomy.7 This shows inadequacy of modern science to provide complete relief in terms of effective management of haemorrhoids.

Haemorrhoids are rationally correlated toArshas.According toAcharya Vagbhata, Arshasare the mamsankura (engorged veins) protruding out and obstructing the Guda marga (Anal Canal) which tortures the person like an enemy 2*.*

Acharya Sushruta has mentioned six types of Arshas they are vataja, pittaja, kaphaja, raktaja, sannipataja and Sahaja. Arshas are associated with clinical features such as Mamsankura in guda, Shula, Vedana, Rakta atisrava, daha, Guda kandu, shopha8. Treatment modality for the management of Arshas 9 as advised in Sushruta Samhita are Bheshaj Chikitsa , Kshara Karma, Agnikarma and Shastra Karma .Among these Kshara karma in Arshachikitsa has been adviced in Arshas which are mrudu(soft), Prasruta(broad), Avagadha(deep seated) and Uchrita(bulged up) .10 The use of Kshara is considered effective in management of piles in terms of least complications as it is minimally invasive and better economic suitability as it eliminates the requirement of hospital stay.

Apamarga(Achyranthes aspera) is one such drug which has been used to prepare Kshara and has proven effective in the management of ano-rectal disorders. Exploration of the new Herbal drugs for the preparation of Kshara is the need of the hour as aparmarga is limited by its seasonal availability. According to Acharya Sharangdhara 11 Yava (Hordeum Vulgare Linn.) is one of the Kshara Dravya which is well known for its lekhana property as told in the context of management of Arshas, has been selected as the choice of drug in this study for making of Kshara Sutra, to find out an effective alternative to Apamarga Kshara Sutra in view of its better seasonal availability, effectiveness of cost and ease of accessibility.

An attempt is made to check the efficacy of Yava Kshara Sutra over Apamarga Kshara Sutra in the management of Arshas (3rd & 4th degree Haemorrhoids).

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patient of either gender aged between 20-65 years diagnosed with Arsha (3rd & 4th degree Hemorrhoids).

排除标准

  • 1st and 2nd degree Hemorrhoids Hemorrhoids associated with other fistula in ano fissure in ano rectal prolapse rectal carcinoma ano rectal abscess ulcerative colitis crohns disease portal hypertension tuberculosis systemic illness like diabetes mellitus hypertension HIV HCV AND HbsAg positive patients.

结局指标

主要结局

To evaluate the efficacy of Yava Kshara Sutra in terms of days taken by kshara sutra to slough out the pile mass

时间窗: 7 days

次要结局

  • Apamarga Kshara Sutra is having more efficacy than Yava Kshara Sutra in the management Arshas(3rd & 4th degree Haemorrhoids).(7 days)

研究者

发起方
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital Koppal
申办方类型
Research institution and hospital

研究点 (1)

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