| CTRI Number |
CTRI/2021/12/038866 [Registered on: 23/12/2021] Trial Registered Prospectively |
| Last Modified On: |
06/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess the improvement in the Mental Health using an Ayurveda Intervention among the police personnel of South Delhi. |
|
Scientific Title of Study
|
The prevalence of Mental Health Problems (MHP) and the effect of an Ayurveda Intervention and Cognitive Therapy (ACT Module) in improving the mental health of police personnel of South Delhi. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayakrishnan K |
| Designation |
Ph.D. Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Ph. D scholar, Department of Swasthavritta, All India Institute of Ayurveda, Gautampuri, Sarita vihar, Mathura Road, New Delhi
South
DELHI
110076
India |
| Phone |
07907375917 |
| Fax |
|
| Email |
drjayakrishnan.k@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Medha Kulkarni |
| Designation |
Professor and Head of the Department |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Swasthavritta, All India Institute of Ayurveda, Sarita vihar, New Delhi
South
DELHI
110076
India |
| Phone |
9890355305 |
| Fax |
|
| Email |
medha63@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayakrishnan K |
| Designation |
Ph.D. Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Ph. D scholar, Department of Swasthavritta, All India Institute of Ayurveda, Gautampuri, Sarita vihar, Mathura Road, New Delhi
South
DELHI
110076
India |
| Phone |
07907375917 |
| Fax |
|
| Email |
drjayakrishnan.k@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda, Gautampuri, Sarita vihar,
Mathura Road, New Delhi – 110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda,
Gautampuri, Sarita vihar,
Mathura Road, New Delhi - 110076 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Jayakrishnan K |
All India Institute of Ayurveda |
Room No: 603, Academic Block, 6th Floor, All India Institute of Ayurveda,
Sarita Vihar, Gautampuri, Mathura Road,
New Delhi-110076
South
DELHI |
07907375917
drjayakrishnan.k@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F99||Mental disorder, not otherwise specified. Ayurveda Condition: MANOVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Jatamansi Vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: Hot Water), Additional Information: 2. Brahma rasayana(classical), Route: Oral, Dosage Form: Avaleha, Dose: 15gm, Frequency: OD, Bhaishajya Kala: Abhakta, Duration: 12 weeks, Anupana: Yes - Warm Milk.
3. Naadi Sudhi Pranayama: following a SOP for early morning practice, for 12 weeks
4. Dietary and lifestyle guidelines. | | 2 | Comparator Arm (Non Ayurveda) | | - | Dietary and Life style Modifications | The control group will be advised with dietary and lifestyle modifications beneficial in improving mental health. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Police personnel of all gender.
2. Police personnel up to rank of Sub Inspector currently in service in South Delhi.
3. Willing to participate and provide a signed informed consent.
4. GHQ-12 score greater than the median score of the sample in Stage 1 screening. |
|
| ExclusionCriteria |
| Details |
1. Personnel with known cases of psychiatric disorders.
2. Police personnel suffering from any chronic illness requiring significant
care.
3. Police personnel not willing to participate.
4. Police personnel requiring any emergency medical treatment or Acute traumatic conditions.
5. Participants under anti-psychotics, sedatives, anti-convulsants.
6. Participants with severe substance abuse.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prevalence of Mental health problems in the selected population using GHQ 12 questionnaire and individual prevalence using specific questionnaires.
of Depression, Anxiety and PTSD (Initial prevalence study) |
At the baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in mental health assessed through psychometric scales and improvement of QOL assessed with WHOQOL-BREF of the study participants |
end of 12th week |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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)?
Response - NO
|
|
Brief Summary
|
RESEARCH QUESTION
What is the prevalence of Mental
Health Problems (MHP) among the police personnel of South Delhi and whether an
Ayurveda Intervention and Cognitive Therapy (ACT module) of 12 weeks is
effective in improving the mental health of selected police personnel of South
Delhi when compared to lifestyle & dietary modifications?
ACT module:
Ayurveda intervention and
cognitive therapy protocol is a multi-pronged interventional method including
pharmacological, non-pharmacological and lifestyle components. The
pharmacological component comprises of herbal drugs, Jatamansi (Nardostachys
jatamansi) tablet and Brahma rasayana (poly-herbal Ayurveda
formulation) for internal administration. Non-pharmacological component is yoga
intervention in the form of nadishudhi pranayama following a
Standard operating procedure. Lifestyle modification and dietary regimens for
better psychological health is also the part of the module. The module is
framed so as to tackle the mental health problems in its initial stages through
simple, cost effective, non-invasive methods.
ACT module will be administered
for the study group and Dietary and Lifestyle modifications will be given to
the control group for 12 weeks and the data will be analysed using appropriate
statistical tests.
The expected endpoints of the
study are:
1. Screening of Mental health
problems using GHQ 12 and individual prevalence of Depression, Anxiety and PTSD
2. Improvement in mental health
assessed through psychometric scales and improvement of QOL assessed with
WHOQOL-BREF of the study participants. |