| 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
|
|
|
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.
|