Randomized Open Label Comparative Clinical Study on Management of Depression by Ayurveda and Yoga as Auxiliary Therapies in Combination with Conventional Treatment
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1. Assessment of Changes in the scores of Hamilton Depression Rating Scale (HDRS) in Group I (Ayurvedic + Yoga + CBT+ Conventional) and Group II (Conventional+CBT) in the management of Depression.
研究概览
简要总结
| I. Title of the Project: Randomized Open Label Comparative Clinical Study on Management of Depression by Ayurveda and Yoga as Auxiliary Therapies in Combination with Conventional Treatment. |
|1.
Type / Category of the Project
(Clinical Research, Pharmacology,
Chemistry, Botany, Literary or any
other)
Clinical Research
|2.
Mandate of Institute
Central Ayurveda Research Institute
|3.
Name & Qualification of the
Principal Investigator(With complete
Address, Ph. No / Mob. No &
E-mail etc.
Name**: Dr. DipSundar Sahu**
Qualification: B.A.M.S., M.D (Ay), PhD
Postal Address: Central Ayurveda Research Institute, 4 CN Block, Sector-V, Bidhannagar, Kolkata - 700091
Telephone / Mob. No: +91-8895173999
Fax: 033-23671001
E-mail: drdssahu@gmail.com
|4.
Name & Qualification of the Co-
Investigator(s) (With complete
Address, Ph. No / Mob. No &
E-mail etc.
**(A)**Name: Dr. Manabendra Makhal
Qualification: MBBS, MD Psychiatry
Area of Interest: Interdisciplinary Psychiatry,
Child Psychiatry
Postal Address: 32 Gorachand Road, Beniapukur, Kolkata – 700014
Telephone / Mob. No: +91-9434199011
E-mail: drmakhal@gmail.com
**(B)**Name: Prof. Pritha Mukhopadhyay
Qualification: MA, PhD
Area of Interest: Manasa Roga
Postal Address: 92 APC Road, University of Calcutta, Kolkata - 700009
Telephone / Mob. No: +91-9433331666
E-mail: prithamukhopadhyay@gmail.com
(C) Name: Dr. Prasanta Kumar Roy
Area of Interest: Manasa Roga
Postal Address: 7 D.L. Khan Road, Institute of Psychiatry, Kolkata – 700025
Telephone/Mob. No.: 9433484612
E-mail: prasanta.roy@gmail.com
**(D)**Name: Dr. Abhijit Ghosh
Qualification: MSc, PhD
Postal Address: Student Welfare Officer, Swami Vivekananda Yoga Anusandhana Samsthana, 69K Prince Bakhtiar Shah Road, Kolkata-700033
Telephone / Mob. No: 9945704400
E-mail: abhijityoga@gmail.com
|5.
Complete Postal address of the
Institute / Organisation responsible
for the Project
Central Ayurveda Research Institute,
4CN Block, Sector-V, Bidhannagar, Kolkata-700091
|6.
Complete Postal address of Other
Participating Institutes, if any
- Department of Psychiatry
Calcutta National Medical College
32 Gorachand Road, Beniapukur, Kolkata –
700014
- Department of Psychology, University of
Calcutta, 92 APC Road, University of
Calcutta, Kolkata– 700009
- Department of Clinical Psychology, Institute of Psychiatry, 7 D.L. Khan Road, PGME&R,
Kolkata- 700025
- Vivekananda Yoga Anusandhana Samsthana,
69K Prince Bakhtiar Shah Road, Kolkata-
700033
|7.
Project Cost
Rs.56,25,520/-
(Rupees Fifty six lakh Twenty five thousand Five hundred twenty only)
|8.
Duration of the Project
02 years
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of either sex in the age group
- •60 years irrespective of socioeconomic status. 2)Patients diagnosed with depression based on the ICD-10 classification of mental disorders provided by the World Health Organisation and are currently experiencing a depressive episode of at least a 60-day duration at the time of screening. 3)Patients with score of 20 or higher on the Hamilton Depression Rating Scale (HDRS). 4)Willing to participate and able provide signed informed consent. [HDRS score of 0–7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial. The original version contains 17 items (HDRS17) pertaining to symptoms of depression experienced over the past week. A later 21-item version (HDRS21) included 4 items intended to subtype the depression, but which are sometimes, incorrectly, used to rate severity]. Reference: Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:56–62.
排除标准
- •Patients with poorly controlled Hypertension (>160/100mm of Hg), Diabetes Mellitus (HbA1c>8.0), unstable cardio-vascular disease, concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit) or other concurrent severe disease, any concurrent renal disorders (S.
- •Creatinine>1.2mg/dl), Patients with evidence of malignancy, with severe COPD, hypothyroidism or hyperthyroidism.
- •Patients with a history of stroke or Transient Ischemic Attack (TIA), epilepsy 3)Patients with schizophrenia spectrum or other psychotic disorders, OCD, PTSD, including major depressive disorder with psychotic features, or Bipolar I or Bipolar II Disorder, antisocial personality disorder, aggressive impulses, or severe cognitive, language, or hearing deficits 4)Patients having the H/o concomitant other substance abuse, moderate or severe alcohol or drug use disorder.
- •Patients with Past suicide attempt, Active suicidal risk (history of suicide attempts to be evaluated on a case by case basis).
结局指标
主要结局
1. Assessment of Changes in the scores of Hamilton Depression Rating Scale (HDRS) in Group I (Ayurvedic + Yoga + CBT+ Conventional) and Group II (Conventional+CBT) in the management of Depression.
时间窗: Baseline, Fifteenth Day, Thirtyth Day, Ninetyth Day, One Hundred Fifth Day, One Hundred Twentyth, One Hundred Fiftyth Day, One Hundred Eightyth Day
次要结局
- 1. Improvement in of Quality of life as assessed through WHO QoL BREF questionnaire.(2. Change in Clinical global impression rating scale (Annexure – IV).)
研究者
Dr DipSundar Sahu
Central Ayurveda Research Institute, Kolkata