A double blind randomized comparative clinical study to evaluate the efficacy of Ashtamangal Ghrita and Brahmi Ghrita in the management of generalized anxiety disorder (Vishada)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary outcome of the study will be the Change in Hamilton’s anxiety rating scale.
研究概览
简要总结
Generalized Anxiety Disorder (GAD), a prevalent mental health condition characterized by excessive worry and anxiety, can significantly impact daily functioning and quality of life if left untreated. While pharmacological interventions exist, Ayurveda offers alternative and complementary therapies with potential efficacy and fewer side effects. The concept of "Vishada," as described in the Shreemad Bhagavad Gita, particularly in the Arjuna Vishada Yoga, aligns with anxiety symptoms such as trembling, sweating, dry mouth, body shaking, goosebumps, burning sensations, apprehension, and fear of future events. Acharya Sushruta classified "Vishada" as a "Manasa roga" (mental disorder) in the Sushruta Samhita, with Dalhan further explaining it as a state of despair due to fear of failure. Similarly, Acharya Charaka examined Vishada in "Viman Sthan" and categorized it as a "Nanatamaj Vataj Vikara." This study aims to compare the efficacy of Ashtamangala Ghrita and Brahmi Ghrita in managing Generalized Anxiety Disorder (Vishada). The objectives include assessing their impact on Hamilton’s Anxiety Rating Scale, Pittsburgh Sleep Quality Index (PSQI), and serum cortisol levels, along with their effects on symptoms of Vishada and GAD. The null hypothesis (H0) states no difference in efficacy between the two formulations, whereas the alternative hypothesis (H1) suggests a difference. This Phase 2, single-center, randomized, double-blind, comparative clinical study will involve 60 patients over 28 days (4 weeks). Statistical analysis will include Mean, Standard Deviation, and Standard Error (SE), with intra-group assessment using the Wilcoxon matched-pairs signed ranks test for non-parametric data and the paired t-test for parametric data. Inter-group comparisons will utilize the Mann-Whitney test for non-parametric variables and the unpaired t-test for parametric variables.
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研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex between the age of 20–60 years, Fulfilling DSM V diagnostic criteria for GAD and willing to participate in the study and having any sign and symptoms of Generalized Anxiety Disorder and Vishada will be included in the study.
排除标准
- •Patients with symptoms of co-morbid psychiatric disorders, on psychotropic drugs, doing substance abuse like alcohol, tobacco , opium etc.
- •and who having significant depression and other medical serious systemic diseases like cancer, tuberculosis etc and uncontrolled Hypertension, Diabetes Mellitus and dyslipidemia will be excluded in the study.
- •Pregnant and lactating women will be excluded from the study.
- •Having history of hypersensitivity or allergy to study drugs, Severe renal impairment (eGFR less than 30 mL/min/1.73 m²),Hepatic impairment (aspartate aminotransferase or alanine aminotransferase more than 2 times the upper limit of normal), Uncontrolled hypertension (systolic blood pressure more than 180 mmHg or diastolic blood pressure more than 100 mmHg)and Presence of any other serious medical condition that may interfere with study participation will be excluded from the study.
结局指标
主要结局
The primary outcome of the study will be the Change in Hamilton’s anxiety rating scale.
时间窗: From Base line(0th day)to 28th day
次要结局
- Change in Pittsburgh Sleep Quality Index (PSQI)(Change in Serum Cortisol level)