跳至主要内容
临床试验/CTRI/2024/08/071839
CTRI/2024/08/071839尚未招募不适用

Randomised controlled clinical trial to study the effect of Rajikushthadi Lepa in Pama with special reference to scabies in school going children

Dr Shruti Bhaskar Bhadane1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2024年8月15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
74
试验地点
1
主要终点
Reduction in signs and symptoms of pama like Kandu(itching),Tod(pain),Dah

研究概览

简要总结

According to Indian journal of paediatric dermatology prevalence of scabies in school going children in India is 11 percent. Developing resistance to commonly used drugs like permethrin underscores the need to explore alternative options for local applications.Rajikushthadi lep sounds promising with its kandughna (anti-itch) and kushthaghna (anti-dermatosis) properties, especially considering itching (kandu) is a characteristic feature in (Pama). Addressing itching is crucial in managing various skin conditions including those associated with Pama. Conducting research to evaluate the effectiveness of Rajikushthadi Lepa in treating Pama is crucial for expanding our understanding of traditional remedies and their applications in modern healthcare. By filling the knowledge gap, the study can provide valuable insights into the potential benefits of Rajikushthadi Lepa and its role in managing Pama. Including patients within the school-going age group (6-12 years) who fulfill the clinical diagnostic criteria for scabies, patients are selected irrespective of sex, socio-economic status, and community helps in achieving a diverse and representative sample, enhancing the generalizability of the study findings, written consent from parents ensures ethical compliance and transparency in the treatment process. SAMPLE SIZE using formula by Daniel 1999, the calculated sample size is 37. Simple Random Sampling technique will be used. Total 74 number of patients will be selected and divided into two groups, named as Group A (trial group) and Group B (Control group).Rajikushthadi lepa Group A (trial group) and Mulakbijadi lep Group B(Control group) will be given to patients.Trial and control drugs will be purchased from GMC certified pharmacy. Both drugs will be administered in Lepa form for 11 days. All SOP of Lepa Vidhi will be strictly followed during and after treatment. Observations will be done on day 0, day 3 and day 7. Result of study will drawn on basis of criteria of assessment and statistical analysis.Discussion will be done on the basis of observations and result obtained during the treatment.Summary will be drawn and whole thesis work will be summarized. Conclusion will be drawn strictly on basis of statistical analysis and will be unbiased

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
6.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Patients of school going age group (6 -12 years) Patients fulfilling the clinical diagnostic criterion for scabies Selection of patient will be performed irrespective of sex, socio economic status and community Parents willing to give consent in written for the treatment.

排除标准

  • Patients of other age group Pama associated with immunodeficiency disorders such as HIV Scabies with crust or hyperkeratosis and secondary infection Known cases of systemic disorders such as diabetes mellitus type 1 Pama associated with any secondary infection.

结局指标

主要结局

Reduction in signs and symptoms of pama like Kandu(itching),Tod(pain),Dah

时间窗: 11 days

(burning sensation),Pitika(Burrows),Strav(discharge) after application of Rajikushthadi lepa

时间窗: 11 days

次要结局

  • To compare the effect of trial & control drug on following signs & symptoms of pama(Kandu(itching)Toda(Pain))

研究者

发起方
Dr Shruti Bhaskar Bhadane
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Shruti Bhaskar Bhadane

SMBT ayurvrd college and hospital

研究点 (1)

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