| CTRI Number |
CTRI/2024/11/076856 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [smriti meditation] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The role of smriti meditation in reducing frequency of migraine headache associated with stress |
|
Scientific Title of Study
|
Effect of Smṛti meditation in the frequency of migraine associated with moderate to severe stress – A single group pre-test post-test design |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ALMA P WILSON |
| Designation |
MD SCHOLAR |
| Affiliation |
VPSV Ayurveda College Kottakkal |
| Address |
Department of Kayachikitsa
VPSV Ayurveda College Kottakkal
Malappuram
Malappuram
KERALA
676501
India |
| Phone |
8547187355 |
| Fax |
|
| Email |
almapwilson96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VINOD R |
| Designation |
Professor |
| Affiliation |
VPSV Ayurveda College Kottakkal |
| Address |
Department of Kayachikitsa
VPSV Ayurveda College Kottakkal
Malappuram
Malappuram
KERALA
676501
India |
| Phone |
9846302667 |
| Fax |
|
| Email |
drvinodvarier@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VINOD R |
| Designation |
Professor |
| Affiliation |
VPSV Ayurveda College Kottakkal |
| Address |
Department of Kayachikitsa
VPSV Ayurveda College Kottakkal
Malappuram
Malappuram
KERALA
676501
India |
| Phone |
9846302667 |
| Fax |
|
| Email |
drvinodvarier@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kayachikitsa OPD
VPSV Ayurveda College Kottakkal
Malappuram
Kerala
676501
India |
|
|
Primary Sponsor
|
| Name |
Alma P Wilson |
| Address |
VPSV Ayurveda College Kottakkal
Malappuram
Kerala
676501 |
| Type of Sponsor |
Other [Self] |
|
|
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 VINOD R |
VPSV Ayurveda College Hospital Kottakkal |
Department of Kayachikitsa
Kayachikitsa OPD
Room no- 104
Malappuram
KERALA |
9846302667
drvinodvarier@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G438||Other migraine. Ayurveda Condition: SIRORUK, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Smṛti meditation | (Procedure Reference: , Procedure details: Smṛti meditation will be given as 6 sessions. First 3 sessions within 2 weeks & next 3 sessions in a gap of 15 days. Each session is of 1-2 hrs. Total duration of study will be 90 days including 30 days follow up.)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Those fulfilling the ICHD-3 migraine diagnostic criteria
2.Perceived Stress Scale value greater than 13
3.Those having frequency of migraine 2 or more in every month for the last 90 days
4.Age group between 18 to 40 years
5.No discrimination of gender, religion, and economic status
6.Those willing to give written consent |
|
| ExclusionCriteria |
| Details |
1.Those under continuous prophylactic medication for migraine.
2.Those undergoing medication for hypertension.
3.Pregnant and lactating mother
4.Known case of cardiac disease, epilepsy, psychiatric disorder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of smá¹›ti meditation in the frequency of migraine associated with
moderate to severe stress. |
90 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the effect of smá¹›ti meditation in moderate to severe stress among the
participants having migraine.
2.To assess the effect of smá¹›ti meditation in the quality of life of participants having
migraine. |
90 Days |
|
|
Target Sample Size
|
Total Sample Size="11"
Sample Size from India="11"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/12/2024 |
| 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="1"
Months="6"
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
|
The main objective of the study is to assess the effect of smṛti meditation in the frequency of migraine associated with moderate to severe stress. 11 participants satisfying the inclusion criteria will be selected from the OPD of Vaidyaratnam P S Varier Āyurveda College Hospital, Kottakkal. Smṛti meditation will be given as 6 sessions. First 3 sessions within 2 weeks and next 3 sessions in a gap of 15 days. Each session is of 1-2 hrs. Total duration of study will be 90 days including 30 days follow up. Effect will be assessed with the assessment tools and data will be analyzed with adequate statistical tests. |