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临床试验/CTRI/2024/03/063805
CTRI/2024/03/063805尚未招募Phase 3 4

A randomized controlled clinical study to evaluate the efficacy of Jatiphaladi Vati in Arsha with special reference to 1st and 2nd Degree Internal Haemorrhoids.

Vd Bhausaheb Prataprao Suryawanshi1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年3月15日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Relief in pain in ano.

研究概览

简要总结

Haemorrhoid is a one of the anorectal disorder which is commonly seen in the society. According to Modern Science ,Arsha is correlate with Haemorrhoid .Haemorrhoid is a varicosity and Dilatation of haemorrhoidal veins of anal canal .As Per Ayurveda The Disease ’Arsha ’ comes under the heading of Maharogas .Because it dushchikitsy,,dirghakalanubandhi and involves the Marma.Arshas is a clinical condition in which structural derangement take place. As per ayurveda, the vitated doshas (vatta,pitta ,kapha )contaminate the twak,mansa,rakta,meda and hampers the function of apan vayu , causes Mansa ankuras at the anal opening .Heamorrhoids is very common ano rectal disease.About 50% to 60% of the people will have heamorrhoid at same point in their lives.Haemorrhoids have conservative as well as surgical treatment as like Cryosurgery,Dilatation, Haemorrhoidectomy, Heamo rrhoid stapling , Rubber band ligation and Sclerotherapy, but not all of them have been uniformly successful. As compared to conservative treatment surgical procedure are expensive, post opeartive pain is unbearable.so patient are not willing for surgical intervention..In Ayurveda Bhaishajakarma is the first line of treatment because there is no fear of complication,bleeding and putrification in comparison of others.Ayurveda has mentioned many herbal formulation of arshas. Hence a randomized controlled clinical study to evaluate the efficacy of Jatiphaladi Vati in arsha with special reference to 1st and 2nd degree internal haemorrhoids study was undertaken.

In this study 80 patients will be randomly selected showing signs and symptoms of internal haemorrhoids and are randomied into 2 groups.Trail group will be treated with the standared treatment with Jatiphaladi Vati while control group will be treated with ayurvedic prepration Tab.Pilonash. In clinical study patient will be examined according to subjective criteria which includes 1.Gudgatraktastrav (Per rectum bleeding),2.Gud Kandu (Anal itching),3.Gudshool (Pain at anal region)by Visual Analogue Scale and objective Criteria Including 1.Degree Of Pile, 2.Malavshtambha(Constipation), by Victoria Bowel Perfomance Scale 3.Laboratory Blood Chemistry Tests as under 1.CBC,2.BT,3.CT,4.Stool examination for occult blood if required.The observations will be drawn after completion of clinical study and conclusion will be drawn accordingly. The study will be published after completion of trail.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patient Diagnosed with 1st and 2nd degree of Internal Haemorrhoids of both sexes.
  • Patients having following Clinical features of Arsha.
  • a)Agnimandya b)Saraktamala Pravrutti c)Gudashool d)Malavshtambh e)Gudakandu 3)Patient willing to participate with informed written consent.

排除标准

  • 1.Pregnant women and lactating mother 2.Severe anaemic patient 3.Patient having systemic disorders like portal hypertension,liver cirrhosis 4.Patient having immunocompromise disordres 5.Bledding disorders like haemophillia and purpura.

结局指标

主要结局

Relief in pain in ano.

时间窗: 28 days

Stopage of per rectal bleeding

时间窗: 28 days

Anal itching

时间窗: 28 days

次要结局

  • Decrease in symptoms like bleeding per rectum,itching and pain at anal region(28 days)

研究者

发起方
Vd Bhausaheb Prataprao Suryawanshi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Bhausaheb Prataprao Suryawanshi

Ayurved Seva Sanghas Ayurved Mahavidyalaya Nashik

研究点 (1)

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