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临床试验/CTRI/2023/07/054863
CTRI/2023/07/054863尚未招募2/3 期

A randomised controlled clinical trial on efficacy of Navaka Kashaya and Manjisthadi Tail in the management of Vicharchika with special reference to dry eczema

NATIONAL INSTITUTE OF AYURVEDA DEEMED TO BE UNIVERSITY1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年1月8日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Change in the EASI Score

研究概览

简要总结

INTRODUCTION

In Ayurveda,various skin diseases have been described under the term Kushtha. Vicharchikais a type of kshudrakushtha ,characterized by skin eruption withdark discoloration, itching and profuse discharge, being involved of threedoshas with the dominance of kapha acc to Acharya charak. Authors like Vagabhatta, Madhavakara and Bhavamishrado agree with him whereas Sushruta,‘the father of surgery’ has mentionedthe symptoms as dryness of the skin with intensive itching and markedthickening of skin, with the dominance of pitta. Similarly difference ofopinion exists between the other texts like Kashyapa*,* Harita*,* Bhelaetc, However Allthe authors have concluded with the fact that itching and eruption are cardinal symptoms.

Vicharchikahas been included under raktapradoshaja vikara.Being a type of kustha, recurrence & chronic course is common. It isskin disease with predominance of kapha with clinical features like kandu,srava, pidika, shyavata, rookshata, raji, rujaand daha mainly in extremities. It has social impact, affectspsychological status and disturb the social life due to its appearance, severeitching disturbing the routine.

NEED OF STUDY

In maximum of cases, patientscome to ayurveda treatment after not getting satisfactory cure from  modern medicine, naturally by the time the disease has attend thechronic state , hence it is the need of the hour to find out safe andeffective medicine for Vicharchika on a long term and here comes the role ofAyurveda.

To overcome the problem ofhigh rate of recurrence,  this trial drughas been selected which is effective in destroying all types of kushthaas mentioned in the phalashruti of trial drugs .These drugs helps todestroy the samprapti of vicharchika (Eczema) due to its ushnavirya and katu-kashaya  rasaand enchances the cure rate to the patient of vicharchika and check itsrecurrence.

AIM: To evaluate and compare the efficacy of “Navaka Kashaya & ManjisthadiTail†in the management of Vicharchika w.s.r. to Dry eczema withStandard Control Drugs (Betamethasone oint. & Tab Hydroxyzine).

OBJECTIVE

·       Evaluation and comparisonof effect of trial drugs  on signs andsymptoms of Vicharchika with special reference to Dry Eczema.

·       Evaluation and comparisonof effect of trial drugs on  EASI Score.

·       Evaluation and comparisonof effect of trial drugs on Extent of impairment in QoL by using DLQI(Dermatology Life Quality Index)

RESEARCH QUESTION

Is there any difference ineffect between the trial drugs and standard control drugs in the management ofVicharchika with special reference to Dry Eczema?

HYPOTHESIS

**Null Hypothesis (H0):**There isno difference between the effect of Trial drug (“Navaka Kashaya and Manjisthadi Tailâ€) and standard controldrug(Betamethasone oint. & Tab Hydroxyzine) in the management ofVicharchika w.s.r to Dry Eczema.

Alternative Hypothesis:

(H1): There is difference between the effect of trial drug( “Navaka Kashaya and ManjisthadiTailâ€)  and standard control drug (Betamethasoneoint. &tab Hydroxyzine)  in themanagement of Vicharchika w.s.r. to Dry Eczema.

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
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients age between 18-60 years Patients of either sex Patients having any signs and symptoms of Vicharchika (Eczema) like Vaivarnyata (Discolouration) Rukshata (Dryness) Kandu (pruritis) Rajii (Thickening of skin) Patients having chronicity less than 5 years.

排除标准

  • Patients with Steroid and cytotoxic treatment(>5 years).
  • Patient having concomitant illness( like-HIV, Malignancy, any immuno-compromised state.) patient having associated skin disease like-vitiligo, psoriasis etc.) Pregnant or lactating women Patient participated in any clinical trial for last 6 months.

结局指标

主要结局

Change in the EASI Score

时间窗: 42 Days

次要结局

  • Change in Sign and Symptoms of Vicharchika with special reference to Dry Eczema andChange in the Extent of impairment in QoL by using DLQI(Dermatology Life Quality Index).

研究者

发起方
NATIONAL INSTITUTE OF AYURVEDA DEEMED TO BE UNIVERSITY
申办方类型
Research institution and hospital

研究点 (1)

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