A Clinical Study to Evaluate the Safety and Efficacy of Brahmi Ghrita and Shankhapushpi Panak in the Management of Chittodvega with special reference to Generalized Anxiety Disorder.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Patients of either sex 18 to 60 years old diagnosed as Chittodvega (Generalized Anxiety Disoredr) will be selected for relief in sign and symptoms.
研究概览
简要总结
Ayurveda, the science of life, is the supreme theory with unerring factors based on Tridosha and Panchabhautic principles. This system, with its eight divisions, encompassed every angle of a person’s health, ailments and treatments which were highly comprehensive. Ayurveda, though ancient, but still contemporary and potential enough to deal the diseases of present era. Chittodvega is Manas Roga and develops due to vitiation of Raja and Tama. Chittodvega can be defined as a Chitta (mind) + Udvega (anxiety) i.e. ‘Anxious status of a mindâ€. Nidana Sevana aggravates Raja, which further aggravates Tama along with Vata and Pitta. Chittodvega is one of the minor psychological disorders (no disorientation as the patient can perform his/her day to day activities without much difficulty i.e. neurosis) and neurosis may develop psychosis. It can be correlated with Generalized Anxiety Disorder on the basis of etymology of Chittodvega (anxious state of mind), type of psychological disorder (neurotic Disorder) and symptomology (both are psychosomatic disorder). Generalized Anxiety Disorder present with persistent, excessive, and/or unrealistic worry associated with muscle tension, impaired concentration, autonomic arousal, feeling "on edge" or restless, and insomnia . In present era, the occurrence of many diseases has increased and one of them is mental disorder, which is mentioned as 3rd health burden in India according WHO survey. Current estimate suggest that 6.8 million adult worldwide suffer from Generalized Anxiety Disorder. According to a survey in India of total sample sample size of 33,572 yielded an estimated prevalence rate of 20.7% for all neurotic disorders, the weighted prevalence rate of Generalized Anxiety Disorder is 5.8% (ref an overview of indian research in anxiety disorders). The modern medical treatment of this disease requires long term use of sedative, hypnotic and anxiolytic drugs, which may lead to various side effects and affects the quality of life of the patient. But the treatment should cure the disease without developing any other disease. So, there is a need of better treatment with less complications.In Chittodvega, there is a vitiation of Vata and Pitta along with Rajas and Tama. The treatment should be of Vatahara and Pittahara along with Medhya Prabhava. Therefore, the drugs with the above said qualities are needed for alleviating the symptoms of Chittodvega. Keeping all above points in mind, the two compound drugs Brahmi Ghrita and Shankhapushpi Panak have been selected to know their effect in treating Chittodvega (Generalized Anxiety Disorder). Brahmi Ghrita is described in Bhava Prakasha under ‘Apasmaradhikara ’; contains Brahmi, Shankhapushpi, Vacha, Kustha and Goghrita. Brahmi is Tridoshshamaka and has Medhya Prabhava, Secondly; Shankhapushpi Panak is described in Ayurveda Sara Sangraha, under ‘Panak Kalpana’, containing Shankhapushpi, Brahmi and Sharkara. Shankhapushpi is Tridoshshamaka especially Vata-Pittashamaka and has Medhya Prabhava.The drugs are to be administered orally. The contents of the drugs are cheap and easily available so the treatment cost is minimal and can be afforded even by poor patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient willing to sign the consent form.
- •Patients of either sex with age between 18 to 60 years.
- •Patient fulfilling the Diagnostic and Statistical Manual of Mental Disorder , Fourth Edition (DSM – IV).
- •Patient who score at least 14 on the Hamilton Anxiety Rating Scale (HARS – A) at baseline visit.
排除标准
- •1.Chittodvega is due to direct physiological effect of a substance (e.g. A drug abuse, a medication ) or a general medical condition (e.g. Hyperthyroidism).
- •2.Occurence of Chittodvega exclusively during mood disorder, a psychotic disorder or a pervasive development disorder.
- •3.Patients having chronic diseases like Diabetes Mellitus, Ischemic Heart Disease, Dyslipidaemia, Hypertension, Malignancies, Chronic Renal Failure, any Endochrinological disorders etc.
- •will be excluded.
- •4.Patients who have completed participation in any other clinical trial during the past six months.
- •5.Pregnant or lactating women.
- •6.Any other condition which the Investigator thinks may jeopardize the study.
- •7.Patients receiving Anxiolytic Drugs will be excluded.
结局指标
主要结局
Patients of either sex 18 to 60 years old diagnosed as Chittodvega (Generalized Anxiety Disoredr) will be selected for relief in sign and symptoms.
时间窗: 30 days
次要结局
- To compare efficacy of Brahmi Ghrita and Shankhapushpi Panak in the management of Chittodvega (Generalized Anxiety Disorder).(30 days)
