A Randomized Controlled Clinical Trial Of Ashwathyadi Lep In The Management Of Mukhapak In Children Of Age Group 5-16 yrs
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- To reduced the daha, tod, athyadhik lalastrav, pitavaivarnya,, kandu, aruchi lakshanas
研究概览
简要总结
Title
A Randomized Controlled Clinical Trial of Ashwathyadi Lep in the Management of Mukhapak in Children of age group 5-16 yrs
Primary objective
To study the efficacy of Ashwathyadi lep in the Management of Mukhapak in Children 5-16 yrs
To compare the effect of local application of Ashwathyadi Lep and glycerin in mukhpak
Secondary objective-
To study the ayurvedic literature of mukhpak
To study the literature of glycerin
Ti study the drug ashwathya and its uses
To study th drug ashwathya and ashwathyadi lep from ayurvedic samhitas and to study the preparation of Ashwathyadi lep
Group A and Group B will Respectively give Ashwathyadi lep and Glycerin for local application in mukhpak for 7 days
Clinical assessment will be done on 3 rd, 5th and 7th day
Inclusive criteria
School age children (5-16yrs)
Irrespective of Gender Religion and Socioeconomic condition
Patient with Classical Signs and Symptoms of Kaphaj Pittaj and Vranaj Mukhapak
Exclusive criteria
Mouth Ulcer due to viral, fungal, bacterial infection
Patient having or suffering from other diseases or systemic disorders
Patient with HIV, VDRL, HBSAG positive and immunocompromoised patient
If the patient is non co-operative
Withdrawal criteria
Patient will be withdrawn from the study if the patient refuses the treatment inspite the consent taken before
If the patient is non co-operative
If some complications happen
If severity of disease increases
Primary outcome
Reduce Signs and Symptoms of Mukhapak
Secondary outcome
No recurrence of Mukhapak
Patient is observed before and after treatment
Data will be collected using CRF and will be observed in the form of tables and graphs
Data analysis- observed data will be analysis strictly on the basis of statistical analysis
Ethical consideration - the study will be conducted in accordance with ethical guidelines and with informed consent from participants
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
- 5.00 Year(s) 至 16.00 Year(s)（—）
入选标准
- •Irrespective of Gender Religion and Socioeconomic condition Patient with Classical Signs and Symptoms of Kaphaj Pittaj Vranaj Mukhapak.
排除标准
- •Mouth Ulcer due to viral fungal bacterial infection Patients having or suffering from other diseases or systemic disorders Patient with HIV, VDRL, HBSAG positive and immunocompromoised patidnt If thr patients is non co operative.
结局指标
主要结局
To reduced the daha, tod, athyadhik lalastrav, pitavaivarnya,, kandu, aruchi lakshanas
时间窗: Outcome will be asses on 3rd, 5th and 7 th day of treatment
次要结局
- To check pain & functional status according to visual analogue scale(Outcome will be asses on 3rd 5th 7th day)
研究者
Dr Ayush Rajendra Dandawate
Shree Saptashrungi Ayurved Mahavidyalay And Hospital Kamal Nagar Hirawadi Panchavati Nashik