A clinical trial to evaluate the combined efficacy of Saraswatha churna and Thungadrumadi taila in managing mixed depressive and anxiety disorder
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- 1.To evaluate the combined efficacy of Saraswatha Churna and Thungadrumadi Taila in managing mixed depressive and anxiety disorder
研究概览
简要总结
A CLINICAL TRIAL TO EVALUATE THE COMBINED EFFICACY OF SARASWATHA CHURNA AND THUNGADRUMADI TAILA IN MANAGING MIXED DEPRESSIVE AND ANXIETY DISORDER
Mental health is a crucial part of overall well-being, beyond just the absence of mental illnesses. It is essential for both individual happiness and optimal functioning. Anxiety and depression are the most prevalent mental health issues on a global scale. Mixed Depressive and Anxiety Disorder (MDAD) is a condition characterized by the presence of both anxiety and depression symptoms, occurring for at least two weeks on most days and these symptoms do not individually meet the diagnostic criteria for a distinct anxiety or depressive disorder.
MDAD can be corelated to Vishada in Ayurveda. Vishada is one among the Nanatmaja Vatavyadhis mentioned in Charaka Samhitha and may appear at any stage of life in a person. It affects a person with Avara Satva and Tamasika Guna.Even though Vishada is a psychological disorder mentioned in Ayurvedic texts, its detailed description is unclear, making diagnosis challenging. Many Ayurvedic researches have attempted to compare it with Generalized Anxiety Disorder (GAD) and Depression, but a concrete conclusion has been elusive. This study, tries to assess Ayurvedic and related literature alongside modern Psychology to determine the alignment between Vishada’s presentation and MDAD in terms of both psychological and somatic aspects.
This is a proposed interventional study with pre and post-test without control group. Subjects of both gender in the age group 18 to 40 years registered in the OPD of Pankajakasthuri Ayurveda Medical College and Post Graduate Centre Hospital, Kattakada, satisfying the inclusion criteria will be subjected to positive sampling and subjects will be selected for the study. Subjects will be enrolled into the study after necessary investigations from a recognized Standard laboratory and after assessment with HAM-A, HDRS, WHOQOL and SSEIT questionnaires. Dose and dosage regimens are fixed according to Ayurvedic classics.
In this study, Saraswatha Churna in a dosage of 6g with honey and ghee will be administered to the 26 subjects, orally twice daily before food, along with Thungadrumadi Taila as Murdhni Taila for 30 days. Saraswatha Churna serves as a cognitive enhancer with anxiolytic properties, improving memory while also possessing carminative attributes. Thungadrumadi Taila, on the other hand, is applied as a Tarpana treatment for the brain (Kapalamajja), a vital intervention along the Madhyama Roga Marga that addresses conditions with potential recurrence. Assessment will be done on 0th day, 16th day, 31st day and 46th day by using subjective and objective parameters. The results will be analyzed statistically and conclusion will be drawn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects of age 18 – 40 years.
- •2.Subjects irrespective of gender and socio-economic status.
- •3.Subjects fulfilling ICD-11 criteria for Mixed Depressive and Anxiety Disorders.
排除标准
- •1.Subjects scoring more than 17 in HAM-A.
- •3.Subjects taking medication for Depression/Anxiety/ other Psychiatric disorders.
- •4.Subjects who are known allergic to any of the ingredients.
- •5.Pregnant and lactating women.
- •6.Subjects with substance abuse.
- •7.Subjects with uncontrolled systemic disorders.
- •8.Subjects with violent behavior and self-harming actions and/or has suicidal ideations.
结局指标
主要结局
1.To evaluate the combined efficacy of Saraswatha Churna and Thungadrumadi Taila in managing mixed depressive and anxiety disorder
时间窗: Clinical assessment of symptoms of MDAD as per ICD-11 criteria, HAM-A, HDRS on 0th day, 16th day, 31st day and on 46th day | Serum cortisol at 8 am on 1st day and 31st day | Assessment of emotional intelligence using SSEIT score on 0th day and 46th day | Assessment of the quality of life in an individual using WHOQOL score on 0th day and 46th day
2.To determine the combined efficacy of Saraswatha Churna and Thungadrumadi Taila in improving the emotional intelligence of an individual using SSEIT questionnaire
时间窗: Clinical assessment of symptoms of MDAD as per ICD-11 criteria, HAM-A, HDRS on 0th day, 16th day, 31st day and on 46th day | Serum cortisol at 8 am on 1st day and 31st day | Assessment of emotional intelligence using SSEIT score on 0th day and 46th day | Assessment of the quality of life in an individual using WHOQOL score on 0th day and 46th day
3.To determine the combined efficacy of Saraswatha Churna and Thungadrumadi Taila in improving the quality of life in an individual using WHOQOL questionnaire
时间窗: Clinical assessment of symptoms of MDAD as per ICD-11 criteria, HAM-A, HDRS on 0th day, 16th day, 31st day and on 46th day | Serum cortisol at 8 am on 1st day and 31st day | Assessment of emotional intelligence using SSEIT score on 0th day and 46th day | Assessment of the quality of life in an individual using WHOQOL score on 0th day and 46th day
次要结局
- To evaluate the safety of Saraswatha churna in subjects with Mixed Depressive and Anxiety Disorder(Blood Routine Examination with Erythrocyte Sedimentation Rate, Liver Function Test, Renal Function Test will be done on 0th day and 31st day)
研究者
Dr Arjun Chand C P
Pankajakasthuri Ayurveda Medical College and Post Graduate Centre