| CTRI Number |
CTRI/2025/04/085844 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Trial to Determine the Therapeutic effect of Varmam therapy in the management of Nettira Pavuttira Vatham ( Trigeminal Neuralgia) |
|
Scientific Title of Study
|
An Open Single Arm Clinical Trial to determine the therapeutic effect of Varmam therapy in the management of Nettira Pavuttira Vatham ( Trigeminal Neuralgia) among out patients attending Ayothidoss Pandithar Hospital, National Institute of Siddha |
| 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 Deepa Nandhini L |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Varma Maruthuvam, National Institute of siddha, Tambaram Sanatorium
Chennai
TAMIL NADU
600047
India |
| Phone |
8838466221 |
| Fax |
|
| Email |
deepanandhini1242@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 |
| 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 |
| 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,chennai-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 |
| Deepa Nandhini L |
National Institute of siddha |
OPD room no 15, Department of Varma maruthuvam, Ayothidoss pandithar hospital, National Institute of siddha Tambaram sanatorium
Chennai- 600047
Chennai
TAMIL NADU |
8838466221
deepanandhini1242@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, National institute of siddha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G500||Trigeminal neuralgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Varma Therapy |
Varma therapy involves Manipulating vital points connected to energy pathways(nadis) to maintain health and treat diseases. The Varma therapy is administered in a sitting posture, Twice a week with a 3 - day interval for 15-20 minutes per session, over a course of 14 sittings, a period of 48 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 years , Participants diagnosed with trigeminal Neuralgia according to International classification of Headache Disorders edition ICHD-3 diagnostic criteria. Participants who are taking medications. Classical Trigeminal Neuralgia of more than 3 months |
|
| ExclusionCriteria |
| Details |
1. Dental disorders
2. Tempero- mandibular joint disorder
3. Migraine or sinusitis
4. Temporal arteritis
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
pain intensity - Reduction
of 2 points in Numerical pain rating (NPRS) scale |
1st day , 48th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement of quality of life by using Penn-FPS-R Questionnaire |
48 Days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
09/05/2025 |
| 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
|
Varma, a fundamental concept in Siddha medicine, refers to vital points connected to the body’s energy pathways. Manipulating these points can restore body energy, treat health conditions, and enhance well-being. This single-arm open clinical trial aims to determine the therapeutic effect of Varmam therapy in managing Nettira Pavuttira Vatham (Trigeminal Neuralgia) using Numerical Pain Rating Scale and Penn-FPS-R questionnaire. The study involves 20 patients who will receive Varmam therapy twice a week for 14 sittings, with each session lasting 15-20 minutes. The expected outcome is a reduction of 2 points in Numerical Pain Rating Scale from baseline score and improvement in quality of life assessed by Penn-FPS-R questionnaire. |