| CTRI Number |
CTRI/2024/09/074348 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on the management of work related Stress among Police personnel by integrating Ayurvedic Foot massage with Yoga. |
|
Scientific Title of Study
|
Combined effect of Padaabyanga with Ksheerabala Taila and selected Yoga techniques on Stress among Police personnel within the age group 25-50 years in Ernakulam disrict. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhijith M P |
| Designation |
PG Scholar, Department of Swasthavritta |
| Affiliation |
Government Ayurveda College, Tripunithura |
| Address |
Second year PG Scholar, Department of Swasthavritta, Government Ayurveda College, Tripunithura,Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
9567337265 |
| Fax |
|
| Email |
abhigadha827@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayan D |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurveda College, Tripunithura |
| Address |
Professor, Department of Swasthavritta, Government Ayurveda College, Tripunithura,Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
9447104383 |
| Fax |
|
| Email |
dr.jayan.d@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayan D |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurveda College, Tripunithura |
| Address |
Professor, Department of Swasthavritta, Government Ayurveda College, Tripunithura,Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
9447104383 |
| Fax |
|
| Email |
dr.jayan.d@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College and Hospital Tripunithura Ernakulam, Kerala-682301 India |
|
|
Primary Sponsor
|
| Name |
Goverment Ayurveda College, Tripunithura |
| Address |
Goverment Ayurveda College, Tripunithura,Puthiyakavu Ernakulam Pincode: 682301 |
| Type of Sponsor |
Other [Goverment Ayurveda College, Tripunithura] |
|
|
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 Jayan D |
Government Ayurveda College and Hospital, Tripunithura |
Department of Swasthavritta Government Ayurveda College and Hospital,Puthiyakavu,Dhanwantari Nagar, Tripunithura, 682301, Ernakulam, Kerala,India.Ernakulam Kerala
Ernakulam
KERALA |
9447104383
dr.jayan.d@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL COMMITTEE FOR ETHICS IN RESEARCH GOVERNMENT AYURVEDA COLLEGE TRIPUNITHURA ERNAKULAM 682301 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F01-F99||Mental, Behavioral and Neurodevelopmental disorders. Ayurveda Condition: MANA-SANTAPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: ksheerabala taila, Reference: sahasrayogam, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -ksheerabala taila will be used for padaabhyanga before bath | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: Padaabyanga with ksheerabala taila , Ritucarya: , Acara Rasayana:, Other:selected yoga techniques, Pathya/Apathya:, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Police personnel who are available at the particular station during study. 2. Police personnel are at the ranks of civil police officer, ASI, and sub-inspector. 3. Police personnel having operational stress score mild to moderate (20-80).
4. Police personnel who are willing to practice yoga. |
|
| ExclusionCriteria |
| Details |
1.Non cooperative police personnel.
2.Police personnel diagnosed with acute illness during the study period.
3.Case of severe systemic illness.
4.Police personnel who having severe spine related issues(IVDP)
5.Case of malignancy.
6.Psychiatric disorders.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the combined effect of ksheerabala taila padaabhyanga and selected yoga techniques for 30 days by assessing
the change in Operational stress score. |
Treatment period- 30 days
Assesesment will be done 0th and 31st day with operational police stress scale. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in stress scores. |
0th day and 31st day |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
15/10/2024 |
| 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="0"
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
|
A clinical trial with 45 subjects will be selected from the OPD of Swasthavritta Department Govt. Ayurveda College Tripunithura based on inclusion and exclusion criteria. Stress scores will be assessed before intervention. The subjects will be given ayurvedic management ( padaabhyanga with ksheerabala taila and selected yoga techniques ) for 30 days. Assessment will be done on 0 th, and 31st day. data will be collected using a case performa. collected. The outcome of the study will be assessed processed and analyzed statistically. |