A Comparative Clinical Study Of Shirodhara And Abhyanga With Tila Taila In Nidranasha w.s.r To Insomnia.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To study Difference between efficacy of shirodhara and abhyanga to reduce symptoms of nidranasha .
研究概览
简要总结
Title A comparative clinical study of shirodhara and abhyanga with tila taila in nidranasha w.s.r to insomnia .
Primary research question Is there any difference between efficacy of shirodhara and abhyanga with tila taila in nidranasha ?
Primary Hypothesis There is significant difference between efficacy of shirodhara and abhyanga with tila taila in nidranasha .
Null Hypothesis There is no difference between efficacy of shirodhara and abhyanga with tila taila in nidranasha .
Primary objective To compare shirodhara and abhyanga with tila taila in nidranasha .
Secondary objective To study literature aspect of shirodhara ,abhyanga , nidranasha and insomnia .
To prepare methodology and sop for clinical trial .
To conduct clinical trial
To assess efficacy after result .
Methodology Study design - Open label randomized comparative clinical trial .
Study centre- Hospital of our institution .
study population - Patients having classical sign and symptoms of nidranasha w.s.r to insomnia .
Overall duration of study -18 months
Sample size - 30 in each group , group A and B Total 60 .
Inclusion criteria - Patients fulfilling the diagnostic criteria of nidranasha and insomnia .
Age group -20 to 60 years
Gender - both male and female
Patients irrespective of religion , economical status , education and occupation etc.
Exclusion criteria - Patients who are mentioned shirodhara anarha and abhyanga anarha in classical text.
age group below 20 and above 60 yrs .
Patients with stroke ,heamorrhagic disorder , epilepsy and psychotic disorder .
Patients is on medication that cause sedation , chronic alcoholism , drug dependent .
Rashes, cut ,abrasion ,injury .
Withdrawal criteria - Sudden increase in sign and symptoms .
Patients want to discontinue treatment despite of giving consent .
Patients who will not following instruction and follow ups of treatment .
Patients who will not continuous for 7 days of treatment ..
Treatment administration
Grouping group A
Intervention shirodhara
Drug Tila taila
Quantity 1500 ml
Duration 7 days
Time for Procedure 45 mins
Period of changing drug Tila taila change every 3 days
Temperature lukewarm
follow up After 7.14.21. days
Grouping Group B
Intervention Abhyanga
Drug Tila taila
Quantity 150 ml
Duration 7 days
Time of procedure 35 mins
Period of changing drug Fresh each day
Temperature lukewarm
Follow up After 7,14,21 days
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients fulfilling diagnostic criteria of Nidranasha and Insomnia.
- •Age group from 20 yrs To 60 yr .
- •Patients irrespective of gender, religion, economic status education occupation.
排除标准
- •Patients who are mentioned as Shirodhara and abhyanga anarha in classical text.
- •Age group below 20 yrs and above 60 Yrs.
- •Patients with stroke, hemorrhagic disorder, Epilepsy and other psychotic disorder.
- •Patients is on medication that can cause sedation, Chronic alcoholism , Drug dependency .
- •Rash, Cut, Abrasion , Injury .
结局指标
主要结局
To study Difference between efficacy of shirodhara and abhyanga to reduce symptoms of nidranasha .
时间窗: 7 days intervention with follow up on 7th , 14th ,21th day
次要结局
- To study if there is no difference between efficacy of shirodhara and abhyanga to reduce symptoms of nidranasha .(7 days of intervention with follow up on 7th,14th,21th day .)
研究者
Rutuja Rangrao Darekar
MES ayurveda mahavidyalay and research Center