Study on effect of Guduchi modak in Psychological Distress in adolescent girls of age 12 to 19 years: a Double-blind, Randomized, Prospective, Parallel group, Placebo controlled clinical trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
1.INTRODUCTION
Adolescence is a transitional phase of growth and development between childhood and adulthood. The word adolescent comes from the Latin verb adolescent meaning “To grow up. According to WHO adolescents lies in between 10 -19 yearsof age. Because of the physical, psychological, and sexual changes that occur during adolescence, the psychiatric complaints like depression, anxiety, and stress occurs during this phase of life is a cause for alarm. The world’s highest population of adolescents live in India that is 253 million and every 5th individual is in the middle of 10 to 19 years. In adolescent the term psychiatric morbidity is defined as abnormality in relationship, emotions, general behaviour and activity which is developmentally inapt and responsible for persistent suffering or handicap the adolescents and/or distress to the households or society. Adolescents experience psychosocial issues at some point during their growth. The majority of these issues are temporary and generally go unrecognized. It’s worth noting that adolescents can have these issues in one situation but not in another (e.g., family, school and friend’s circle). Consequently, these psychiatric morbidities are often misinterpreted. They may be measured intentional or purposefully, their self-esteem may be diminished as a result of social exclusion, sanctions, and criticism. Children and teenagers may be denied the help they require due to a faulty and improper understanding of these mental illness. “Adolescence is a critical period characterized by vulnerability to psychological distress and is therefore an important time for promotion of psychological wellbeing and early mental health intervention, in order to safeguard against the development of mental health issues. Adolescence is frequently marked by fresh stress, behavioural changes, relationship issues, which have an impact on psycho -social development. Adolescent children who have their parents taking part in their life are better able to deal with challenges and maintain their physical and emotional wellbeing. High levels of parental participation and the formation of a close relationship between children and parents have been linked to lower rates of depression and loneliness among young people in high-income countries.
2.NEED OF STUDY
As the prevalence of mental health problems in adolescents in India is high, with estimates ranging from 6.5% to 23.3%, it is important to invest in adolescents and to build on Indigenous ways of child and adolescent health promotion. Adolescents with mental health conditions are particularly vulnerable to social exclusion, discrimination, stigma (affecting readiness to seek help), educational difficulties, risk taking behaviours, physical ill -health and human rights violations. Modern psychiatry still has limitations to access the diversity of mind and its functional aspects. Etiopathogenesis of several psychiatric morbidities are still mysterious, and contemporary management is often only partially effective along with lots of adverse effects. Ayurveda Medhya Rasayana are specifically indicated for maintenance of mental/psychological well-being. Several studies also certify that these drugs have nootropic as well as psychotropic effect and work variously to improve the psychological functioning of an individual. Therefore, it is supposed that these drugs can be beneficial in this area also. With all these issues in mind, this study is planned with an intension to know the prevalence of pshychological distress among adolescents of jaipur so that further interventions can be done in terms of prevention and promotion of better health.
3.RESEARCH QUESTION
Is Guduchi modak effective in management of psychological distress in adolescent girls?
4.HYPOTHESIS
NULL HYPOTHESIS (H0)- Guduchi modak has no effect in the management of psychological distress in adolescent girls.
ALTERNATIVE HYPOTHESIS (H1)-Guduchi modak has significant effect in the management of psychological distress in adolescent girls.
5.AIM
To evaluate the efficacy of Guduchi modak in the management of Psychological distress in adolescent girls.
6.OBJECTIVES
Primary objective
To evaluate the efficacy of Guduchi modak in the management of Psychological distress in adolescent girls.
Secondary objective
To compare the effect of Guduchi modak and placebo in the management of Psychological distress in adolescent girls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 19.00 Year(s)(—)
- 性别
- Female
入选标准
- •Adolescents of age between 12 to 19 years.
- •Adolescents having signs and symptoms of psychological distress (according to scale).
- •Overtly healthy adolescents.
- •Adolescents whose parents are wiling to give consent for clinical trial.
排除标准
- •Any past history of diagnosed mental illness.
- •Any severe mental illness requiring hospitalization.
- •Adolescents suffering from major systemic illness necessitating long term treatment like, Known Case of Anemia, Hypothyroidism and Juvenile Diabetes mellitus.
- •H/o hypersensitivity to any drug.
- •Adolescents whom parents are not wiling to give consent for clinical trial.
研究者
Dr Simranjeet Kaur Rolla
National Institute of Ayurveda
