A randomised controlled clinical trial to study the effect of Arjunadi lepa in Ahiputna with special reference to napkin rash in children.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Improvement in the diaper rash assessment scale
研究概览
简要总结
Napkin rash or diaper dermatitis of thigh and buttocks results from exposure to urine and faeces in infant diapers.In initial years of life children are more prone to diseases emerging due to unhygienic conditions as upto this age child has not developed full control over bladder and bowel .Ahiputna can be correlated with Diaper rash where kapha and rakta dushti occurs.It’s prevalance is about 7-35%.
Arjunadi lepa selected for the study is having antibacterial pitta kaphaghna vranropak properties so can be very useful in treating Ahiputna. Children of age group group 1 month to 2 years will be selected for the study irrespective of sex socioeconomic status and fulfilling inclusion criteria.Sample size using formula by Daniel 1999 the calculated sample size is 90. For this study it. is divided into two. groups each containing 45 patients.Simple random sampling technique will be used.Group A (Trial group) and group B (control group) each containing 45 patients Group A will be given Arjunadi lepa and Group B will be given Triphaladi Raskriya.Both drugs will be purchased from GMC certified pharmacy.
Both drugs will be administered in lepa form for 7 days.All SOP of lepa vidhi will be strictly followed during the treatment observation will be done on day 0 day 3 and day 7.
Null Hypothesis (H0): Arjunadi lepa is not effective in the treatment of Ahiputna between the age group of 1 month to 2 years .
Alternative Hypothesis (H1): Arjunadi lepa is effective in the treatment of Ahiputna between the age group of 1 month to 2 years
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
- 1.00 Month(s) 至 2.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient of age group 1 month to 2 years Patient suffering from sign and symptom of Ahiputna Selection of patient wil be performed irrespective of sex socio economic status and community Parent willing to give written consent.
排除标准
- •Children above the age group of 2 years and below 1 month Children suffering from any other systemic disorder dehydration acute gastrointeritis secondary infection Children who have other generalized skin infection.
结局指标
主要结局
Improvement in the diaper rash assessment scale
时间窗: Reduction in symptoms of diaper rash after 7 days of treatment
次要结局
- Where the trial group stands in comparison with the control group(18 months)
研究者
Dr Poonam Abaso Khaladkar
SMBT Ayurved college and hospital