A Randomized open labelled comparative clinical study to evaluate the combined efficacy of Brahmyadi churna and Asvagandha churna with Satwavjaya chikitsa in the management of Chittodvega with special reference to Generalised Anxiety Disorder.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Significant decrease in signs and symptoms of GAD assessment based on Hamilton Anxiety rating Scale
研究概览
简要总结
Anxiety disorders are the most prevalent mental health issues across the world. Generalized anxiety disorder (GAD) is one among the most common kind of anxiety disorders characterized by persistant, excessive, and difficult to control worry and other associated symptoms such as fatigue, difficulty in concentration, sleep disturbances, restlessness, and abdominal discomfort.
According to W.H.O Covid 19 pandemic triggered 25% increase in prevalence of anxiety and depression worldwide . Prevalence of Anxiety was found to be 35%, stress 53% in a study conducted on the population of 113,285 individuals.
According to NHMS Survey the overall prevalence of Anxiety Disorders in the adult population was found to be 2.57% and prevalence of GAD was found to be 0.57%.
Generalised anxiety disorder is twice as common in women than men and often associated with chronic environmental stress.
Usually patient seeks medical help because of the somatic complaints associated with GAD like muscle ache and tension, headaches, backaches, gastrointestinal issues, problems with sleep and fatique. All these leads to increased disability and decreases the quality of life of a person .Individuals with GAD are at significantly increased risk of impaired social and role functioning, mental health, and overall physical-mental well-being.
Clinical trials have shown that anxiolytic drugs alone have limited long-term efficacy. Moreover , they often have adverse side effects including dependency, drowsiness, impaired cognition and memory, and sexual dysfunction. Considering wide magnitude of GAD in Indian subcontinent and absence of promising therapy suffering population is turning towards other systems for effective therapies. Being an alarming disease, it requires effective management.
In Ayurveda an exact co-relation to Generalised Anxiety Disorder is not found, but Udvega means anxiety, fear, distress or agitation and Chittodvega can be taken as affliction of mind with these,therefore in this study the term Chittodvega is compared with Generalised Anxiety Disorder.
Acharyas have mentioned different Medhya Rasayanas for the management of mental illnesses and also Satwavajaya Chikitsa is a unique non-pharmacological approach for treating the mental disorders.
Satwavajaya Chikitsa mentioned among Trividha Chikitsa by Acharya Charaka not only prevents the impairments of Dhee, Dhriti and Smriti but also brings them back to the normal state, playing a significant role in the maintenance of harmonious state between these three factors ultimately leading to happy healthy state of individual.
Considering that Brahmyadi Churna along with Satvavjaya Chikitsa are taken as trial intervention for the present study.
Whereas Ashvagandha Churna is a proven anxiolytic drug hence along with Satwavajaya Chikitsa it is taken as a control intervention for the present study.
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
- •1.Subjects fulfilling criteria based on DSM-5 and those getting score between 8-23 in Hamilton Anxiety Rating Scale will be included in the study.
- •2.Subjects suffering from GAD for a minimum period of atleast 6 months 3.Subjects between age group of 20 to 60 years irrespective of gender.
- •4.Subjects willing to sign consent form.
排除标准
- •1.Subjects on use of anxiolytics or antidepressants in the previous 6 months.
- •2.Subjects diagnosed with other psychiatric illnesses like mood disorder, psychosis, depression etc.
- •from past 12 months.
- •3.Subjects suffering from Generalised anxiety disorder associated with other serious systemic illnesses that would interfere with the treatment.
- •4.Subjects with uncontrolled hypertension , diabetes mellitus , thyroid dysfunction, renal dysfunction, organic mental disorder or psychoactive-substance related disorder, such as excess consumption of alcohol, amphetamine-like substances, or withdrawal from benzodiazepines.
- •5.Pregnant and Lactating Women.
结局指标
主要结局
Significant decrease in signs and symptoms of GAD assessment based on Hamilton Anxiety rating Scale
时间窗: Before intervention- 0th | After intervention- 28th | Follow Up- 43rd day.
次要结局
- Generation of in depth analysed data on different aspect of Disease .(Generation of Data on possible unexpected drug reaction)
研究者
Dr Anupam
Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore