| CTRI Number |
CTRI/2015/08/006099 [Registered on: 14/08/2015] Trial Registered Retrospectively |
| Last Modified On: |
12/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Pranic Healing] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effects of Pranic healing on people with depression |
|
Scientific Title of Study
|
A Randomized Controlled Trail, Double Blind trial to compare the Effects of Pranic Healing on Depression |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajagopal |
| Designation |
Associate Professor Department of Psychiatry |
| Affiliation |
Mysore Medical College and Researcher Institute |
| Address |
Irwin Road Near Mysore Railway Station
Mysore
Karnataka
Mysore
KARNATAKA
570021
India |
| Phone |
0821-2520512 |
| Fax |
|
| Email |
drrajgopal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumanth M M |
| Designation |
Associate Professor, Department of Psychiatry |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
Irwin Road Near Mysore Railway Station
Mysore Karnataka
Mysore
KARNATAKA
570021
India |
| Phone |
0821-2520512 |
| Fax |
|
| Email |
drsumanthmmc@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Srikanth Jois Nagaraja |
| Designation |
Head of Research |
| Affiliation |
World Pranic Healing Foundation, India - Research Centre |
| Address |
44 4th Main 1st Cross Saraswathipuram
Mysore
Mysore
KARNATAKA
570009
India |
| Phone |
0821-2340673 |
| Fax |
|
| Email |
srikanth@pranichealing.co.in |
|
|
Source of Monetary or Material Support
|
| World Pranic Healing Foundation, India ®
|
|
|
Primary Sponsor
|
| Name |
World Pranic Healing Foundation India Research Centre |
| Address |
# 44, 4th Main 1st Cross Saraswathipuram
Mysore 570009 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajagopal |
Mysore Medical College & Researcher Institute |
Counselling room, Department of Psychiatry
Mysore Medical College & Researcher Institute
K.R. Hospital
Irwin Road, Near Mysore Railway Station,
Mysore, Karnataka
Pin: 570021
Mysore
KARNATAKA |
0821-2520512
drrajgopal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Mysore Medical College & Researcher Institute and associate hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Depression – Mild to moderate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Active group: Receives base line standard treatment for Depression according to international guidelines. ESCITALOPRAM - 10 mg once daily for 1month
AND
20 minutes of complementary therapy of Pranic Healing sessions once a week for 4 weeks
|
Active group: Receives base line standard treatment for Depression according to international guidelines. ESCITALOPRAM - 10 mg once daily for 1month
AND
20 minutes of complementary therapy of Pranic Healing sessions once a week for 4 weeks
|
| Comparator Agent |
Inactive group: Receives base line standard treatment for Depression according to international guidelines.
ESCITALOPRAM - 10 mg once daily for 1 month
|
Inactive group: Receives base line standard treatment for Depression according to international guidelines.
ESCITALOPRAM - 10 mg once daily for 1 month
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria
• Male and Female Patients diagnosed with Depression at Mild / Moderate levels
• age group of 20 to 60 years
• Able to give informed consent
• Interested to receive complementary therapy of Pranic Healing
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
• Major ailments such as liver or renal failure or cardiac diseases or vital organ failure
• Any other severe progressive and uncontrolled medical condition
• Not willing to give informed consent
• Not able to perform all study related procedures
• Subjects with significant suicidal risk upon assessment
• Patients requiring additional anti-Psychiatric drug like patients with Insomnia.
• pregnant women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hamilton Depression Rating Scale (HAM-D)
|
1. To reduce Depression Symptoms
2.To increase participation in physical and social activities
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Social activities and mobility |
4 weeks
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/08/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
www.doi.org/10.1177/1039856217726449 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a Double
Blind, Randomised Controlled Trail to assess the Effects of Pranic Healing on
Depression. There is scientific evidence about complementary and alternative
treatment aiding in recovery. Complementary therapies are used along with
conventional medicine. Studies have not being conducted on effects of Pranic
Healing on Depression. This study aims to alleviate the patient’s conditions
from Depression with a complimentary therapy of Pranic Healing along with
conventional medicine.
The Active
group Receives base line standard treatment for Depression according to international guidelines. ESCITALOPRAM -
10 mg once daily for 1month, In
addition they receive the active intervention of 20 minutes of complementary
therapy of Pranic Healing sessions once a week for 4 weeks. The Inactive group
Receives base line standard treatment
for Depression according to international guidelines. ESCITALOPRAM -
10 mg once daily for 1 month along with mock Pranic healing sessions. The Proposed study expects higher reduction in
Depression Symptoms of patients and to increase participation in physical and
social activities among group with
pranic healing treatment in addition to regular treatment |