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临床试验/CTRI/2025/02/080948
CTRI/2025/02/080948尚未招募不适用

A Randomised Controlled Clinical Study To Evaluate The Efficacy Of Nyagrodhapatra Lepa With Sooranadhi Lepam In The Patients Of Arshas(II&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: 2025年2月24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
1.To Evaluate The Efficacy Of Nyagrodhpatra lepa In Management 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 disorders. The great Indian surgeon "Sushruta" known as father of Surgery has described Arshas in Sushruta Samhita, Nidana Sthana 2nd chapter and its Chikitsa in Chikitsa Sthana 6th chapter. He considered Arshas as one of the "Ashta Mahagada" means diseases which are very difficult to treat. Arshas was referred as Durnama or Darunakam, the name itself indicates bad. It is a disease that tortures the patient like an enemy, which afflicting mankind for thousands of years.

According to Madhavakara, the disease which kills a man like an enemy is called Arsha.

In modern concept Arshas can be compared with haemorrhoids/piles. Haemorrhoids is a Greek word derived from two words “Haem” =blood ,”Rhoos” = flow, means that blood flows and another is Pile. Pile is a latin word derived from ‘Pile’ that denotes the ball. 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 name Haemorrhoidal venous plexus, characterized by bleeding per rectum, constipation, pain, prolapse & discharge .

Bleeding, pain and prolapsed mass are the three main complaints for which the patient of haemorrhoids usually seeks medical advice.If not treated properly it may lead to complication like haemorrhage , thrombosis, fibrosis, strangulation, suppuration, portal pyaemia etc.,

There are so many procedures for the management of the disease such as sclerotherapy, Rubber band ligation, Cryosurgery, Haemorrhoidectomy etc., But Ayurveda is well known for the treatment of arshas for its negligible rate of recurrence, cost effective, less chances of pain, haemorrhage, infection & anal incontinence. Ayurveda pronounced a comprehensive chikitsa for arshas includes medicinal , surgical as well as para surgical treatments as prevailing today .

Susruta advocates the management of arshas under four principal therapeutic measures .They are as follows: 1.Oushada karma (Medical Management) 2.Shastra karma (Surgical management) 3.Kshara karma (Chemical cauterization) 4.Agnikarma (Thermal cauterization).

It is manifested due to improper diet, prolonged standing & faulty habits of defecation causing derangement of tri-doshas, mainly vata dosha. Vitiated doshas localizes in gudavali pradhana dhamani & mamsadhara kala & vitiates tvak, mamsa, meda & rakta, resulting in the annavaha sroto dushti. These vitiated dosas moves in downward direction , reaches guda and produces sprouts of muscles in guda vali . These sprouts are called Arshas.

The ancient acharyas i.e., susrutha,charaka, chakradutta,vangasena were explained many curative measures for management of arshas. Among them local application is also a method with good cure rate and well tolerance. ShalyaTantra, the integral part of Ayurvedic system contains detailed description of Shastiupakramas. Alepa is mainly used for the shamana of local kupitha doshas and reduces signs and symptoms which are explained in Sushruta Samhita Chikitsa Sthana Dvivraniya adhyaya.

According to Basavarajeeyam,Nyagrodha patra lepa mentioned in arshas chapter.

By application of NYAGRODHAPATRA LEPA prepared by nyagrodhapatra burnt and made into ashes and mixed with oil and applied over pile mass .This subsides haemorroids.

In the present clinical study of Nyagrodhapatra lepa is taken from reference of Basavarajeeyam(ARSHOROGANIDANALAKSHANACHIKITSADYAH,53rd shloka).The ingredients Nyagrodha patra and Tila tailam.

Thus the present study is entitled as A RANDOMISED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF NYAGRODHAPATRA LEPAM WITH SOORANADHI LEPAM IN THE PATIENTS OF ARSHAS (II &III DEGREE HAEMORRHOIDS).

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 64.00 Year(s)(—)
性别
All

入选标准

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

排除标准

  • 1.Concomitant Ano-rectal conditions like Fistula-in-Ano, Fissure.
  • in -Ano and Malignancy. 2.Pregnant women 3.Chronic kidney diseases. 4.Tuberculosis on Anti Tuburcular Treatment
  • Uncontrolled diabetesÂ.

结局指标

主要结局

1.To Evaluate The Efficacy Of Nyagrodhpatra lepa In Management Of Arshas.

时间窗: At baseline after completetion of treatment(1 to 14 days),21st day, 28th day

2.To Know The Role Of Standard Sooranadhi Lepa In Arshas

时间窗: At baseline after completetion of treatment(1 to 14 days),21st day, 28th day

3.To Compare The Efficacy Of Nyagrodhapatra Lepa With Sooranadhi Lepa In Arshas.

时间窗: At baseline after completetion of treatment(1 to 14 days),21st day, 28th day

次要结局

  • 1. To find out safe,simple,effective and economical method of treating Arshas.(2.To find out whether this study drug regress the size of arshas and prevents the recurrence of arshas.)

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

Posam SivaPriyanka

S. V. Ayurvedic College and Hospital

研究点 (1)

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