| CTRI Number |
CTRI/2025/03/082927 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to evaluate the therapeutic effect of Varmam therapy along with Amirdhadhi ennai(Therapeutic oil bath) for the management of Oruthalai vatham(Migraine without aura) |
|
Scientific Title of Study
|
An open single arm clinical trial to evaluate the therapeutic effect of Varmam therapy along with Amirdhadhi ennai(Therapeutic oil bath) for the management of Oruthalai vatham(Migraine without aura) |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suganthi S |
| Designation |
PG scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Varma Maruthuvam National institute of siddha Tambaram sanatorium Chennai Tamil Nadu 600047 India
Chennai
TAMIL NADU
600047
India |
| Phone |
8056935527 |
| Fax |
|
| Email |
suganthisundaram99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Samundeswari P |
| Designation |
Assistant professor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Varma Maruthuvam National institute of siddha Tambaram sanatorium Chennai Tamil Nadu 600047 India
Chennai
TAMIL NADU
600047
India |
| Phone |
9445403599 |
| Fax |
|
| Email |
mdsamuk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Samundeswari P |
| Designation |
Assistant professor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Varma Maruthuvam National institute of siddha Tambaram sanatorium Chennai Tamil Nadu 600047 India
Chennai
TAMIL NADU
600047
India |
| Phone |
9445403599 |
| Fax |
|
| Email |
mdsamuk@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of siddha, Tambaram sanatorium-600047 |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
National Institute of Siddha Tambaram sanatorium - 600047 |
| 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 |
| Suganthi S |
national institute of Siddha |
Varma maruthuvam OPD, Room number:15,
Ayothidoss pandithar hospital, National Institute of Siddha,
tambaram sanatorium,
chennai-600047
Chennai
TAMIL NADU |
8056935527
suganthisundaram99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, National Institute of Siddha, National institute of siddha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G430||Migraine without aura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Varmam therapy along with Amirdhadhi ennai oil bath |
Varmam therapy, manipulates pressure points to restore energy balance. Administered for 15-20 minutes, twice a week for 14 sittings over 48 days along with Amirdhadhi ennai oil bath twice in a week. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age: 18-65 years
All genders
Participants diagnosed with ICHD-3 diagnostic criteria
Participants with HIT-6 score range 50 to 59 Participants with MIDAS score 6 to 20 |
|
| ExclusionCriteria |
| Details |
Tension type of headache
Cluster headache
Sinusitis
Hypertension
Trigeminal neuralgia
Participant who are taking NSAID for migraine |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of clinical signs and symptoms of Oruthalai vatham(Migraine without aura)assessed using Headache Impact Test scale and MIDAS test scale |
for 48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
16/04/2025 |
| 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 Siddha System of Medicine is an ancient traditional Indian system providing preventive, curative, promotive, rejuvenative, and rehabilitative healthcare. Varmam therapy, a unique aspect of Siddha science, stimulates specific vital points ("Varmam points") to balance energy flow and treat various ailments, particularly musculoskeletal pain, injuries, and neurological disorders, through pressure techniques. Therapeutic oil bath is an essential treatment for detoxification, rejuvenation, and relaxation. This study aims to evaluate the therapeutic effect of varmam therapy along with Amirdhadhi ennai (therapeutic oil bath) by assessing the reduction in clinical signs and symptoms of oruthalai vatham(migraine without aura) through Headache impact test scale and Migraine Disability Assessment scale. As per the inclusion and exclusion criteria, 30 selected patients will be included in the study. The included patients will be advised to take varmam therapy. Before starting the treatment, therapeutic oil bath with Amirdhadhi ennai (sufficient quantity) will be given for regulates the mukkutram ( vatham, pitham , kabam) and improves the blood circulation. The Varmam therapy will be done for 15 to 20 minutes, twice in a week with 3 days interval period for 48 days continuously. Patients are requested to visit the hospital OPD weekly twice for the study. In every visit the clinical assessment and prognosis will be noted in the prescribed proformas in the presence of faculty members of Dept. of Varma Maruthuvam. |