CTRI/2024/09/074452 [Registered on: 26/09/2024] Trial Registered Prospectively
Last Modified On:
26/09/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug Ayurveda Yoga & Naturopathy Behavioral
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
The Comparative Management of Mild to Moderate Depression by Conventional Anti-depressants with CBT and Ayush Interventions
Scientific Title of Study
Randomized Open Label Comparative Clinical Study on Management of Depression by Ayurveda and Yoga as Auxiliary Therapies in Combination with Conventional Treatment
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr DipSundar Sahu
Designation
Research Officer (Ayurveda)
Affiliation
Central Ayurveda Research Institute, Kolkata
Address
Central Ayurveda Research Institute, 4 CN Block, Sector-V, Bidhannagar, Kolkata 4 CN Block, Sector-V, Bidhannagar, Kolkata North Twentyfour Parganas WEST BENGAL 700091 India
Phone
8895173999
Fax
Email
drdssahu@gmail.com
Details of Contact Person Scientific Query
Name
Dr DipSundar Sahu
Designation
Research Officer (Ayurveda)
Affiliation
Central Ayurveda Research Institute, Kolkata
Address
Central Ayurveda Research Institute, 4 CN Block, Sector-V, Bidhannagar, Kolkata 4 CN Block, Sector-V, Bidhannagar, Kolkata
WEST BENGAL 700091 India
Phone
8895173999
Fax
Email
drdssahu@gmail.com
Details of Contact Person Public Query
Name
Dr DipSundar Sahu
Designation
Research Officer (Ayurveda)
Affiliation
Central Ayurveda Research Institute, Kolkata
Address
Central Ayurveda Research Institute, 4 CN Block, Sector-V, Bidhannagar, Kolkata 4 CN Block, Sector-V, Bidhannagar, Kolkata
WEST BENGAL 700091 India
Phone
8895173999
Fax
Email
drdssahu@gmail.com
Source of Monetary or Material Support
Central Council for Research in Ayurvedic Sciences, 61-65, opp. D’ Block, D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi 110058, Ministry of AYUSH, Government of India
Primary Sponsor
Name
Central Council for Research in Ayurvedic Sciences
Address
61-65, opp. D Block, D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi, 110058
Type of Sponsor
Research institution
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Manabendra Makhal
Calcutta National Medical College
Psychiatry Department (Pavlov Building), Psychology department, 32 Gorachand Road, Beniapukur, Kolkata - 700014 Kolkata WEST BENGAL
9434199011
drmakhal@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Ethics Committee, Calcutta National Medical College (EC-CNMC) Appraised by CARI, Kolkata
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: G||Mental Health,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Conventional Medicine
As prescribed by the clinical psychologist
Intervention
Counseling & Dhyana
The Dhyana will be for 30 minutes will consist of dhyana on the breath followed by the body scan and after 5 minutes gap the metta bhavana.The details of the meditative instructions are given in Appendix 2. Broadly, the meditation on the breath consists in making the breath the focus of attention and observing the rise and fall of the breath. This followed by the body scan wherein the body sensations from the head to the feet are systematically observed maintain equanimity and tranquility. The metta bavana is generating goodwill for the world both in personal and impersonal aspects and is considered an excellent meditative practice for depression. The meditative session will end in about 30 minutes and 20 minutes are reserved for the queries of the patient.Total Time for Dhyana-30 minutes.
Intervention
Dhanvantara Taila
Dose- 50 ml once daily locally,
Dosage form - Oil,
Route of Administration - External application whole body part,
Time of Administration - Afternoon 04:30 pm for 45 minutes,
Packing form - Pet Bottles (each containing 50 ml),
Duration of therapy - 30 days
Comparator Agent
Group-I: Ayurveda+Yoga+CBT+Conventional (for 40 patients)
Group II – Conventional+CBT(for 40 patients)
Ayurveda Intervention-Ksheerabala Taila for Shirodhara,Dhanvantara Taila for Abhangya
Yoga- Standard yoga protocol
CBT & Dhyana-CBT & Dhyana session guided by clinical psychologists
Conventional medicine-As prescribed by the M.D. Psychiatry, Co-Investigator of the project as per the treatment requirement of the mild to moderate depression patient
Intervention
Ksheerabala Taila
Dose- 450 ml once daily locally for Shiro Dhara,
Dosage form - Oil,
Route of Administration- External application over the head by Dhara,
Time of Administration-Afternoon,
Packing form-Pet Bottles (each containing 450 ml),
Duration of therapy - 30 days
Intervention
Yoga
There will be Yoga session twice (02) per week for Group I for a total of 24 sessions (each session for a duration of one hour thirty minutes) during entire study period
Inclusion Criteria
Age From
18.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
1)Subjects of either sex in the age group 18 - 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.
ExclusionCriteria
Details
1)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.
2)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.
5)Patients with Past suicide attempt, Active suicidal risk (history of suicide attempts to be evaluated on a case by case basis)
Method of Generating Random Sequence
Random Number Table
Method of Concealment
Case Record Numbers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
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.
Baseline, Fifteenth Day, Thirtyth Day, Ninetyth Day, One Hundred Fifth Day, One Hundred Twentyth, One Hundred Fiftyth Day, One Hundred Eightyth Day
Secondary Outcome
Outcome
TimePoints
1. Improvement in of Quality of life as assessed through WHO QoL BREF questionnaire.
2. Change in Clinical global impression rating scale (Annexure – IV).
3. Assessment of Clinical Safety of study participants through laboratory investigations.
4. Proportion of study participants with Incidences of Treatment emergent AE/SAE
5. Assessment of tolerability of interventions
6. Assessment of intervention compliance.
6 months
Target Sample Size
Total Sample Size="80" Sample Size from India="80" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 2/ Phase 3
Date of First Enrollment (India)
07/10/2024
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
07/10/2024
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="2" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Yet Recruiting
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
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