Evaluation of comparative Clinical efficacy of Yastimadhu Rasayana versus Ashwagandha Rasayana in young adults with symptoms of Easy Mental Fatiguability-A Randomized control trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- NA
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Mental Fatigue Scores
研究概览
简要总结
The Title of the Research work: Evaluation of comparative Clinical efficacy of Yastimadhu Rasayana Versus Ashwagadha Rasayana in young adults with symptoms of Easy Mental-Fatiguability – A Randomized control trial.
AIM of the Study
Evaluation of comparative clinical efficacy of Yastimadhu Rasayana Versus Ashwagandha Rasayana in young adults with symptom of Easy mental Fatiguability.
OBJECTIVES
1. To evaluate the efficacy of Yastimadhu Rasayana in the management of Easy mental Fatiguability on the basis of objective and subjective parameters.
2. To evaluate the efficacy of Ashwagandha Rasayana in the management of Easy mental Fatiguability on the basis of objective and subjective parameters.
3. To compare the efficacy of Yastimadhu Rasayana and Ashwagandha Rasayana in the management of Easy mental fatiguability on the basis of objective and subjective parameters.
Hypothesis
RESEARCH HYPOTHESIS:
Alternate Hypothesis (H1) Yastimadhu Rasayana is not inferior in management of Easy mental Fatiguability when compared to Ashwagandha Rasayana.
Null Hypothesis (H0)
There is no difference in the efficacy of Yastimadhu Rasayana and Ashwagandha Rasayana in the management of Easy mental Fatiguability .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who would be ready to accept the treatment protocol guideline as per the study and would give informed consent.
- •All the patients of genders, male and female, of the age group 18 to 30 years, have socioeconomic status in the middle and upper class.
- •Patients belonging to managerial work, student, and academician as an occupation.
- •Patients with symptoms of easy mental fatiguability (Assessed with CIS-R score of more than 26).
- •Patients who are not using any kind of tonics multivitamins for improving general health.
排除标准
- •Patients who are not willing to participate in the trial.
- •Patients with Hb levels less than 13 gm% (male) and 9 gm% (female).
- •Patient with acute and chronic Metabolic, Endocrinal, and nutritional disorders.
- •Patients suffering from chronic debilitating diseases.
- •Patients with alcohol and drug abuse.
- •Patients with evidence of delirium, confusion, and other disturbances of consciousness, psychotropic diseases using any psychotropic drug.
结局指标
主要结局
Mental Fatigue Scores
时间窗: At the baseline (Day 0) and at the end of intervention (Day 61)
CFS Scores
时间窗: At the baseline (Day 0) and at the end of intervention (Day 61)
次要结局
- MFIS Scores ( to measure the impact of mental fatigue )(FSS Scores ( to assess the severity and frequency))
研究者
Mahima Shrivastava
Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H), Wardha,