An Open Labeled, Randomized, Two Arm Study Of Effect Of Yashtimadhu Choorna With Milk On Health And Cognitive Parameters In Healthy Volunteers – A School Based Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- To evaluate the effect of consumption of Yashtimadhu Choorna along with milk on cognitive parameters in healthy volunteers in study group on the basis of
研究概览
简要总结
This is an Open label, Randomized, Multi center, Prospective, Two arm Clinical Study. After obtaining Ethics Committee approval registration at CTRI will be done. After obtaing CTRI registration number, the study will be started. The study will be conducted at Mahatma Phule Vidyaniketan Institution’s Dnyanaprabodhini Madhyamik and Kanishtha Mahavidyalaya, Sasanenagar, Hadapsar Pune 28
Firstly the study design will be explained to the school officials including teachers. After obtaining their consent, parent meeting will be called. The study will be explained in detail to the parents. Each and every possible effort will be taken to answer study related queries. Parents’ attendance will be taken. Also their willingness and correspondence details will be taken. The parents who are willing for participation will be called on next day with their ward for participation eligibility screening.
On screening day, the ascent from child and consent from parent will be taken and then only study related activities will be conducted. At baseline visit, according to randomization, the children will be included in respective groups. One follow up card and one accountability sheet will be issued to each participant. The participant will be instructed to tick on the accountability sheet after consumption of Yashtimadhu Choorna along with milk on daily basis.
Groups Group A (Study Group): the students in this group will be advised to follow their regular routine which they are already following along with consumption of Yashtimadhu Choorna 2.5 gm along with 50 ml of milk , twice in a day for 3 months.
Group B (Control group): the students in this group will be advised to follow their regular routine which they are already following along with consumption of 50 ml of milk twice in a day for 3 months.
Assessment Criteria 1. Digit Letter Substitution Test (DLST) - at baseline visit and at the end of the study. 2. Six Letter Cancellation Test (SLCT) - at baseline and at the end of the study.
3. Improvement in academic performance - at the baseline and at the end of the study. Methodology for Assessment parameters
1. Digit Letter Substitution Test (DLST)
a. The DLST worksheet consists of random digits,1-9, in 8 rows and 12 columns.
b.The coding sheet will have instructions about the test with example of substituting a specific letter for each digit 1-9, the same coding will be applied to an entire test group.
c. Subjects will be instructed to make their own choice of letter substitution strategy, whether horizontally, vertically, or selecting a particular digit randomly in the array one at a time.
d.They will be instructed to substitute as many target digits as possible in the specified time of 90 seconds
2. Six Letter Cancellation Test
a.The six letter cancellation task worksheet consists of random alphabets, A-Z, in 14 rows and 22columns.
b. Subjects will be instructed to seat with the worksheet turned over until the start of the test. All participants to be tested in one group will also be given instruction sheet indicating the six target letters to be cancelled.
c.The instructions will be given regarding cancellation of as many target digits as possible in the specified time of 90 seconds.
d.They will be given the choice of cancellation strategy to do it horizontally, vertically, or selecting a particular letter one at a time randomly in the array.
e. Finally, after ensuring that they have understood the test by answering all their queries they will be instructed to turn over the worksheet and start the test as the bell rings.
3. Academic improvement
a. Discussion with school teacher as well as parents will be done.
b For teacher – the points under discussion will be absenteeism due to illness, attentiveness, energy level, physical fitness, social behavior in class.
c.For parents – the points under discussion will be episodes, severity and duration of illness, energy levels, physical fitness, stamina, social behavior at home.
Accountability - The volunteers in both group shall be inquired and confirmation will be obtained about history of regularity of consumption of Yashtimadhu Choorna with milk/milk with the help of accountability sheet.
Data Analysis - The data obtained through the study will be shared to qualified statistician for performing data analysis. Conclusion will be drawn on the basis of data analysis and study findings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 10.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Apparently healthy volunteers i.e. students of secondary school 2)No significant medical or surgical illness at the time of screening 3)Volunteers and their parents ready for the study and willing for treatment 4)Selection will be irrespective of religion, gender, socioeconomic status, class and standard.
- •Willing to undergo study related procedures.
排除标准
- •Presence of significant medical or surgical illness at the time of screening requiring long term treatment.
- •Volunteers having history of delayed milestones in infancy/childhood 3)K/C/O growth retardation, mentally retarded children.
结局指标
主要结局
To evaluate the effect of consumption of Yashtimadhu Choorna along with milk on cognitive parameters in healthy volunteers in study group on the basis of
时间窗: At the baseline (0 Day) and at the end of the study (90th Day)
1.DLST (digit letter substitution test)
时间窗: At the baseline (0 Day) and at the end of the study (90th Day)
2.SLCT(six letter cancellation test)
时间窗: At the baseline (0 Day) and at the end of the study (90th Day)
3.Improvement in academic performance
时间窗: At the baseline (0 Day) and at the end of the study (90th Day)
2.To evaluate the cognitive parameters in healthy volunteers in control group on the basis of
时间窗: At the baseline (0 Day) and at the end of the study (90th Day)
次要结局
- Assessment of difference in absent days in school due to illness in both groups.(At the baseline (0 Day) and at the end of the study (90th Day))
- Assessment of health status on the basis of episodes, severity and duration of illnesses in both groups.(At the baseline (0 Day) and at the end of the study (90th Day))
- To compare the cognitive parameters in healthy volunteers in either groups on the basis of(1.DLST (digit letter substitution test))
- Assessment of change in energy levels, strength and stamina in both groups.(At the baseline (0 Day) and at the end of the study (90th Day))
- Assessment of growth parameters like height and weight in both groups.(At the baseline (0 Day) and at the end of the study (90th Day))