A Comparative Clinical Study on Patoladi Gel And Standard of Care (Zinc Oxide Ointment) in Management of Ahiputana (Diaper Rash) In Infant
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Significant decrease in Diaper dermatitis scale score (Ahiputana)
研究概览
简要总结
INRODUCTION
Diaper dermatitis is an inflammatory reaction of skin of perineal and perianal areas (Diaper area). It is the most common skin disorder seen in young infants with peak prevalence in 9-12 months of age. Studies report the prevalence varying from 7 to 35 percent.
In Ayurveda the clinical feature of diaper dermatitis closely resemble with Ahiputana .Excessive use of diaper during infantile period is one of the main causes in the development of Ahiputana
.It is common in both rural and urban setting.It leads to behavioral changes in infant characterized by increased crying and agitation and changes in eating and sleeping patterns.This condition is especially distressing for the growing infant and parents too.The management of diaper dermatitis include conservative management i.e. maintaining hygiene and frequent changing of diapers. Other methods of treatment include use of topical emollients, corticosteroids and antibiotics which often lead to skin damage on prolonged usage. Ayurveda treatment advocated by Acharyas in Ahiputana consist of external application of medicated herbs in paste form. However, application of herbs inpaste form present a challenge in infantile age groups. Till date very fewworks have been done on *Ahiputana,*leaving a substantial gap in exploring new form of interventions, which can be easily applied and accepted among infants. Thus, the present study was planned.
OBJECTIVES OF THE RESEARCH PROJECT**:**
Part A : Clinical study
Part B : Cell line study
The present study has been undertaken with the following objectives:-
PRIMARY OBJECTIVES:
To Evaluate the efficacy of Patoladi Gel in comparison with Standard of care (Zinc oxide ointment) in the management of Ahiputana (Diaper rash).
SECONDARY OBJECTIVES:
1)Efficacy of Patoladi Kwatha against skin inflammatory marker in human skin cell line model.
2)Phytoconstituent analysis of Patoladi Gel.
METHODOLOGY:
Sample Size- 60 (30 in Each Group)
Group- 2
Intervention- Group A- Zinc oxide ointment, Group B- Patoladi Gel
Duration- 14 Days
Follow Up - 14 Days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Month(s) 至 12.00 Month(s)（—）
- 性别
- All
入选标准
- •12 months babies using disposable diapers only. 2)Patients of uncomplicated diaper dermatitis. 3)The parent willing to provide written informed consent to participate in the study. 4)ICD -10- CM L22.
排除标准
- •Any type of skin lesion other than the diaper dermatitis.
- •Babies suffering from atopic dermatitis.
- •Babies suffering from systemic illness.
- •Babies on any other treatment for dermatitis.
- •Babies with any Autoimmune disorder.
- •Complicated diaper dermatitis.
- •Any condition which is considered by the investigator to be detrimental to the health of the study participant.
结局指标
主要结局
Significant decrease in Diaper dermatitis scale score (Ahiputana)
时间窗: Significant decrease in Diaper dermatitis scale score (Ahiputana)Baseline,1week,2week,follow up after 14 days.
次要结局
- 1)Efficacy of Patoladi Kwatha against skin inflammatory marker in human skin cell line model.(2)Phytoconstituent analysis of Patoladi Gel.)
研究者
Dr Nasreen
All India Institute of Ayurveda