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CTRI Number  CTRI/2020/03/024060 [Registered on: 19/03/2020] Trial Registered Prospectively
Last Modified On: 20/02/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Treatment of depression using psychiatric and Ayurvedic treatment  
Scientific Title of Study   Integrative Treatment using Ayurveda, Yoga and Psychopharmacological agents for Depression (INTRAP-D) - A pilot study  
Trial Acronym  INTRAP-D 
Secondary IDs if Any  
Secondary ID  Identifier 
DRP/IFP0393/2019  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Virupaksha Shanmugam Harave 
Designation  Assistant Professor  
Affiliation  Ramaiah Medical College 
Address  Dept Of Psychiatry, Ramaiah Medical College, NEW BEL Road, MSR Nagar Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  9886797083  
Fax    
Email  virupaksha.hs@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Virupaksha Shanmugam Harave 
Designation  Assistant Professor  
Affiliation  Ramaiah Medical College 
Address  Dept Of Psychiatry, Ramaiah Medical College, NEW BEL Road, MSR Nagar Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  9886797083  
Fax    
Email  virupaksha.hs@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Virupaksha Shanmugam Harave 
Designation  Assistant Professor  
Affiliation  Ramaiah Medical College 
Address  Dept Of Psychiatry, Ramaiah Medical College, NEW BEL Road, MSR Nagar Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  9886797083  
Fax    
Email  virupaksha.hs@gmail.com  
 
Source of Monetary or Material Support  
Ramaiah Medical College Plan to apply for ICMR grant  
 
Primary Sponsor  
Name  Ramaiah Medical College 
Address  Ramaiah Medical College, NEW BEL Road, MSR Nagar Bangalore -560054 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Planning to apply for ICMR grant    
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Virupaksha HS   Ramaiah Medical College Hospital  New BEL Road, MSR Nagar Bangalore 560054
Bangalore
KARNATAKA 
9886797083

virupaksha.hs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ramaiah Medical College Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Psychopharmacological agents for depression  Standard psychiatry treatment includes the use of antidepressants orally and the follow up schedule being once in 2 weeks to 4 weeks. The treatment protocol will be based on APA practice guidelines.  
Comparator Agent  Standard Ayurveda and yoga treatment includes the oral medications in the form of tablets/ghee (clarified butter) formulation and external application of ayurvedic formulation in the form of paste/oil as prescribed by the Ayurveda guidelines.   The following protocol will be adopted in the management of the cases. Saraswatharishtam (with gold bhasma) - 20ml thrice a day, after food. SG tablet -2 thrice a day, after food Kalyanaka kashayam- 15ml with 45 ml of water, thrice a day, before food. Mahakalyanaka ghrita/ Panchagavya ghrita Shiro abhyanga and shirodhara with himasagara taila for 7 days. The Panchgavya ghrita is the only variant, which will be given to patients willing to take it and to exclusive vegetarian patients. The following Yoga procedures will be taught to subjects and will be monitored by self report and if possible occasional video calls. 1.      Sukshma vyayama - series of exercises for loosening of the joints to initiate muscular activity for 3 minutes depending on patient ability to do. In case of any injury to the joints, such exercises should be avoided. 2.      Abdominal breathing – 10 repetitions 5 times a day. If the patient is unable to do the practice sitting upright, then advised to do in supine position. 3.      Deep breathing in the ratio 1:2 - 20 rounds twice a day. If the patient is unable to do the practice sitting upright, then advised to do in supine position. 4.      Bhramari pranayama 5.      Marjarasana – 5 repetitions twice a day. But it is avoided if patients have injury to shoulders and knees. 6.      Surya Namaskara –To be performed after 2 months based on the overall flexibility of the patient. 7.      Chandranuloma – 10 rounds twice a day  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  DSM V diagnosis of Major depressive disorder for all groups of patients
Mild, moderate and severe severity
Atleast one trial antidepressant treatment  
 
ExclusionCriteria 
Details  Psychotic symptoms
Active suicidal ideas
Neurology diagnosis
Unstable medical condition
Substance use disorders
subjects who are doing regular Yoga in control arm
Drug naive cases of depression
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Depression Score
BDNF level
Quality Of life  
0, 2, 4, 8,12 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Adverse drug reactions   0, 2, 4, 8,12 weeks  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   01/06/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Depression is one of the most common and severe psychiatric disorders with significant morbidity and mortality. The treatment for depression primarily involves use of anti-depressants and psychological interventions. However  20-30% of cases are resistant to known treatments and do not show adequate improvement [1, 2]. Integration of treatments is a well-known modality to overcome the limitations of any one particular type of treatment. Ayurveda is one of the oldest forms of treatment that originated in India treating various forms of physical and psychiatric disorders. These treatments may be in the form of  body massages, specific diet and medications [3].This study aims to study the add-on effect of the Ayurveda and yoga in conjunction with standard psychiatric treatment. The study will have three arms, each of standard psychiatry treatment, standard Ayurveda treatment and the interventional arm which consists of add on Ayurveda and yoga to standard psychiatric treatment with follow up schedule till 6 months post recruitment. The outcome factors being the depression score, quality of life, clinical improvement and ADRs. Informed consent will be taken and standard institutional ethical guidelines will be adhered to. The major clinical implications of the study is in the use of Ayurveda and yoga in standard treatment of depression in reducing morbidity and improving the recovery rate. The study will also look into the molecular markers of improvement in depression. BDNF expression and the levels will be studied across the arms to determine the neurobiological changes. 


 
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