Efficacy of Yashtimadhu In Comparison With Ashwagandha In Stress With Special Reference To Depression Anxiety Stress Scale (DASS-21): A Randomized Control Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Reduction in DASS-21 Scale
研究概览
简要总结
Background: Stress, anxiety, and depression are more common mental health issues that significantly affect individuals’ quality of life. Although there are allopathic treatments for stress, they are often associated with adverse side effects and limited multi-targeted action. In contrast, Ayurvedic herbal remedies, known for their safety and holistic therapeutic effects, are gaining popularity Among them, Yashtimadhu, recognized for its multi-targeted action, particularly on the Manovaha Strotas, has demonstrated neuropharmacological properties, including nootropic, antidepressant, antistress, and anxiolytic effects. Ashwagandha is a well-researched adaptogen that is used extensively for its ability to improve mood and reduce stress. However, there is limited evidence comparing their effectiveness in stress management, particularly in the context of the Depression Anxiety Stress Scale (DASS-21).
Objective: This randomized controlled trial aimed to evaluate and compare the efficacy of Yashtimadhu and Ashwagandha in managing stress, using the
Depression Anxiety Stress Scale (DASS-21) as a primary assessment tool.
Methods: Total 82 participants experiencing stress will be randomly assigned to two groups: Yashtimadhu and Ashwagandha. The trial will have a duration of 3 weeks, with dose of 5gm Churna BD administered according to standard Ayurvedic recommendations. Pre- and post-treatment assessments using the DASS-21 scale will be conducted to measure the levels of depression, anxiety, and stress. The PSS Scale is also used to assess stress.
Results: The results of this study will potentially influence clinical practices and highlight the role of traditional herbal remedies in contemporary stress management strategies.
Conclusion: The final conclusion will be determined after the completion of the randomized controlled trial, which will assess the comparative efficacy of Yashtimadhu and Ashwagandha in the management of stress.
Keywords: Stress, Yashtimadhu, Ashwagandha, DASS-21, mental health, Ayurveda.
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.All the patients with symptoms of stress from at least 15 days to 1 year with a score between 15-33 in the DASS-21 Scale.
- •2.Male and female adults aged between 18 and 65 years.
- •3.Participants are willing to participate in the study and comply with its procedures by signing a written informed consent.
排除标准
- •DASS -21 Score less than 15 and More than
- •Pregnant women and lactating mothers.
- •People with a known hypersensitivity to study medications will be excluded.
- •Patients with serious life-threatening critical illnesses that may interfere with the current study.
- •People reported alcohol dependence and drug abuse.
- •People taking any other investigational drug for another clinical trial/research are also ineligible.
- •Patient with addiction to Narcotics.
- •Patients taking medicines that may interfere with the study outcome.
- •Patients are not willing to participate and are not ready to give written informed consent.
- •Patients having uncontrolled HTN BP > 150/90 mmHg, Known case of Uncontrolled DM with HbA1C >
- •The patient taking any other hormonal or psychiatric treatment since last 1 month.
结局指标
主要结局
Reduction in DASS-21 Scale
时间窗: Day 0,Day 7, Day 14,Day 21
次要结局
- Reduction in PSS Scale(Day 0,Day 7, Day 14,Day 21)
研究者
Yogita Pole
Government Ayurvedic College and Hospital Nagpur Sakkardara