Randomized open controlled clinical study to evaluate the efficacy of japa pushpa taila in darunaka with special reference to pityriasis capitis in children of age group 0 to 18 years.
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To decrease the symptoms of Darunak .
研究概览
简要总结
Aim-To evaluate the efficacy of japa pushpa taila in the management of darunaka with special
reference to pityriasis capitis in children of age group 0 to 18 years.
Objective - Primary
To study the efficacy of Japa pushpa Taila in treatment of darunaka in
children with special reference to pityriasis capitis.
Secondary objective -
-
To study the preparation of Japa pushpa Taila and it’s standardization.
-
To study in detail the literature about darunaka.
-
To study the detail literature about pityriasis capitis in children.
-
To compare effect of Japa pushpa Taila and ketoconazole shampoo 2 percent.
a) Study design – Randomized, open labeled, controlled, clinical study.
b) Study setting- Patient will be selected randomly from OPD of
kaumarbhritya department in our hospital.
c) Duration of study- 18 months.
d) Study Population - Age groups 0 to 18 years of age irrespective of gender.
e) Sampling method – Open labeled sampling method. (lottery method).
Diagnostic criteria :
1)Patients will be diagnosed on the basis of clinical signs
and symptoms of darunaka.
Informed written consent will be taken prior to clinical study.
Case will be recorded on specially designed proforma.
CRITERIA OF ASSESSMENT -
Assessment will be done before and after treatment and will be done on
the basis of following criteria.
A) Subjective Parameter
1- kandu( Itching)
2-keshchutyi(Falling of hairs)
3-Twak Sphutan (Scaling of scalp)
4-Rukshata (Dryness)
B. OBJECTIVE PARAMETERS:
- ASFS (ADHERENT SCALP FLAKING SCORE)
After analyzing, data will be discussed in detail.
Conclusion will be drawn on the basis of data obtained and observation during study.
Data will be summarized on the basis of observation and results.
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
- 0.00 Day(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group between 0-18 years of either sex, irrespective of cast, socioeconomic status.
- •Patient with symptoms of kandu, keshbhoomi rukshata, twaksphutan, keshchyuti.
排除标准
- •Children suffering with K/C/O any systemic and genetic disease.
- •Patient who are restricted to take bath like, karna roga, netra roga and shiroroga.
- •Children with K/C/O chronic scalp disease other than darunaka like allergic scalp.
- •Children suffering with immunosuppressive disease.
结局指标
主要结局
To decrease the symptoms of Darunak .
时间窗: 30 day with follow up on 0,15th,30th day
次要结局
- To study the effects of ayurvedic formulation.(30 day with follow up on 0,15th,30th day .)
研究者
Dr Shreyas Bharat Warule
LRP Ayurvedic medical college and hospital, PG Institute and research centre urun Islampur