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临床试验/CTRI/2024/06/068949
CTRI/2024/06/068949尚未招募3 期

An Open Labelled Clinical Study To Evaluate The Effect Of Intralesion Injection Of Apamarga Kshara In Charmakeela W.S.R To Cutaneous Warts

Sri Dharmasthala Manjunatheswara College Of Ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月22日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
To Find the effect of intralesion injection of Apamarga Kshara based reduction in size and fall off of wart.

研究概览

简要总结

Charmakeela is a disease which causes nail like growth on the skin. Warts are benign epidermal

proliferation caused by infection with Human Papilloma Virus. It is common in children and adult with a high

prevalence of 3-13% in general population.[1] It causes discomfort and hinders confidence, spreads by

autoinoculation or direct contact.

Warts Treatment modalities such as Topical applications of Salicylic Acid and Lactic Acid,

Intralesional Bleomycin or Interferon Injections, Cryotherapy require time to achieve response. Laser therapy,

Surgery- excision, curettage, Electro-cautery have post interventional- local irritation, scarring and pain.[2]

Ayurveda mentions Kshara karma as one of the chikitsa for Charmakeela.[3] Kshara karma is

considered superior among Shastra and Anushastra due to Chedana, Bhedana, Lekhana, Tridoshaghna,

Ropana and Vilayana Karma.

[4] Apamarga, one among the Kshara Dravya has properties of Kaphavataghna,

Arshoghna, Kustapaha. Clinical studies on warts using different Kshara intralesion injection have given a

single sitting response, had least and easy post interventional management and was cost effective. Animal

study of Apamarga Kshara have reported it to be safe at different dose levels and the authors concluded that

the formulations were safe.[5] Hence, this study is intended to evaluate the effect of novel technique of

intralesion injection using Apamarga Kshara on warts.

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 70.00 Year(s)(—)
性别
All

入选标准

  • Cutaneous warts over face, neck region, axilla, hand and feet.
  • Single Warts with less than or equal to 1cm in size (length, diameter).

排除标准

  • 1.Patients contraindicated for Ksharakarma as per texts.
  • 2.Anal Warts 3.Genital warts 4.Mucocutaneous Warts 5.Patients with Systemic disease like Uncontrolled diabetes, Hypertension, Cardiac 6.Immune compromised and Sexually Transmitted Disease.
  • 7.Warts greater than 1cm in size (length, diameter).

结局指标

主要结局

To Find the effect of intralesion injection of Apamarga Kshara based reduction in size and fall off of wart.

时间窗: Observing the wart Based on Assessment Parameters | on 0th day | 1st day, 3rd 6th 9th 12th and 15th after procedure or till wart fall off

次要结局

  • Time taken for wart to shed off(15 days)

研究者

发起方
Sri Dharmasthala Manjunatheswara College Of Ayurveda
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Harshitha M Rao

Sri Dharmasthala Manjunatheswara college of ayurveda,kuthpady,udupi .

研究点 (1)

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