跳至主要内容
临床试验/CTRI/2022/11/047770
CTRI/2022/11/047770尚未招募不适用

A randomized standard controlled clinical trial to access the efficacy of Kushthadi Lepa in the management of PAMA in children.

PDEAs College of Ayurved and Research Centre Sector No.25 Nigdi Pradhikaran,Pune 4110441 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2022年1月12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
64
试验地点
1
主要终点
To study efficacy of Kushthadi Lepa and Vachadi Lepa in PAMA (Scabies)

研究概览

简要总结

Scabies is one of the most common complaints in children seen all over world causing much discomfort in children. Skin diseases have high prevalence throughout the world. Scabies is caused by burrowing and release of toxic or antigenic substances by the female mite sarcoptes scabiei var hominis. Scabies is contagious and can spread through close physical contact so it is an acute communicable disease and highly prevalent in young children.

Scabies is major public health problem with an estimated prevalence of 130 million cases worldwide. The prevalence varies from 0.35 to 46%. The highest rates are found in countries with hot tropical climates where infestation is endemic. The point population in the general population of rural India is about 13%, in Maharashtra 81%, in rural area 72% of cases are seen in the age group below 16 years.

According to modern treatment permethrin 5% cream applied on entire body for scabies. Additional therapies include sulphur ointment 5-10% and crotamiton 10% lotion.

Skin disease in Ayurveda is described as Kushtha roga. There are seven Mahakushtha and eleven number of Kshudra Kushta roga explained. All Kushtha are tridoshaja but they are classified according to Dosha. Pama kushtha is one of the kshudra roga in which Pitta-Kapha is predominating. Pama Kushtha characterized by many small pitika, srava, kandu, toda and daha that may be considered as scabies in contemporary science. It is found that ’PAMA’ Vyadhi Is one of the commonest diseases found in the low-socio economic class and occurs in person who does not follow hygiene. Signs, symptoms, pathogenesis and treatment of Pama are very well described in Ayurvedic texts and there are various Kalpa described in samhitas in Ayurvedic texts.

i.e Kushthadi Lepa is used and the topic is selected.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Open Label

入排标准

年龄范围
3.00 Year(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • Patient who will be clinically with two or more symptoms.
  • itching, pain, burning, eruption, discharge. 2) Selection will be irrespective of gender, religion, and socio-economic class, age between 3 to 14 years.

排除标准

  • Patient suffering from any other systemic disorders such as Skin TB, Leprosy.
  • Pama associated with immune deficiency disorder such as HIV.
  • Scabies with crust or hyperkeratosis and secondary infection, urticaria etc.
  • Suspected patient for Covid-19.

结局指标

主要结局

To study efficacy of Kushthadi Lepa and Vachadi Lepa in PAMA (Scabies)

时间窗: 7 days with follow up on 3rd 5th and 7th day

次要结局

  • To observe the adverse effect of the drug(7 days with follow up on third and fifth day)

研究者

发起方
PDEAs College of Ayurved and Research Centre Sector No.25 Nigdi Pradhikaran,Pune 411044
申办方类型
Private medical college

研究点 (1)

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