| CTRI Number |
CTRI/2025/06/088365 [Registered on: 06/06/2025] Trial Registered Prospectively |
| Last Modified On: |
03/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study on how add on varmam therapy Affects ocular parameters in people with refractive error |
|
Scientific Title of Study
|
Effect of add-on varmam therapy on ocular parameters among individuals with refractive Error - A single-blinded pilot randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rakesh |
| Designation |
First year Masters of Optometry student |
| Affiliation |
Manipal college of health Professions,MCHP,MAHE |
| Address |
Room no 313,3rd floor, Department of OptoMetry Manipal college of health professions, MCHP, MAHE, Manipal, Udupi district, Karnataka, India pincode 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9900649335 |
| Fax |
|
| Email |
rakesh.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arul Amuthan |
| Designation |
Associate Professor |
| Affiliation |
Division of Siddha, Centre for Integrative Medicine and Research (CIMR), MAHE,Manipal |
| Address |
Division of Siddha, Centre for Integrative Medicine and Research (CIMR), MAHE,Manipal, Udupi district, Karnataka, India pincode 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9986353238 |
| Fax |
|
| Email |
arul.amuthan@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
J Salai Dhavamathi |
| Designation |
Assistant Professor –Senior scale |
| Affiliation |
Manipal college of health Professions,MCHP,MAHE |
| Address |
Room no 313,3rd floor, Department of OptoMetry Manipal college of health professions, MCHP, MAHE, Manipal, Udupi district, Karnataka, India pincode 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9176654452 |
| Fax |
|
| Email |
dhavamathi.j@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba hospital,Manipal,Udupi district, Karnataka state,India 576104 |
|
|
Primary Sponsor
|
| Name |
Division of Siddha Endowment fund, CIMR, MAHE |
| Address |
Division of Siddha, Centre for Integrative Medicine and Research CIMR, MAHE, Manipal, Udupi district, Karnataka, India, pincode-576104 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Rakesh |
Kasturba hospital |
Baliga block, 3rd floor Room no 315, Department of Optometry Kasturba hospital and Division of siddha, Centre for Integrative medicine and Research, MAHE, Manipal, Udupi district, Karnataka, India 576104
Udupi
KARNATAKA |
9900649335
rakesh.mchpmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H522||Astigmatism, (2) ICD-10 Condition: H520||Hypermetropia, (3) ICD-10 Condition: H521||Myopia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Spectacles |
Spectacles are the first line and standard management for refrative error |
| Comparator Agent |
Varmam Therapy |
Participants will receive Varmam therapy sessions, administered by certified siddha
practitioners, targeting specific points related to vision and eye health according to traditional
practices. Few ocular-related Varmam points are Manipulated in a feather-touch manner. There are
total 19 points which will be manipulated in this study
The frequency of the therapy is 3 sessions per week for the first three months, then
weekly one session until 6 months. Each session will last for 10 minutes. Patients who missed one-week session (3 continuous sessions/week in the first
three months, weekly one session for rest of the months) will be considered dropouts.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1)Individuals aged 18-35 years with diagnosed refractive errors (myopia, hyperopia, or astigmatism)
of up to ±6.00 dioptres.
2)No history of ocular surgery, trauma, or active ocular diseases.
3)Willingness to participate in Varmam therapy sessions. |
|
| ExclusionCriteria |
| Details |
1)The presence of any systemic diseases affecting the eyes (e.g., diabetes).
2)Individuals undergoing other refractive treatments (e.g., LASIK) and other complementary therapies
for eye health |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Refractive Error in D |
Baseline,first and sixth month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Change in Visual Acuity with Log MAR
2)Intra-ocular pressure in mmHg
3)Accommodation in D
4)Contrast sensitivity in log units
|
Baseline,first and sixth month |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
23/06/2025 |
| 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="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
|
After the approval from ethics committee and Ctri then .Recruitment will be done through advertisements Individuals with refractive error aged 18-35 will be recruited from the OPD of Department of Ophthalmology and Division of Siddha, Centre for Integrative Medicine and Research MAHE, Manipal. Assessment for eligibility will be done based on inclusion and exclusion criteria. After recruitment written inform consent will be obtained after explaining the study’s purpose and procedures. Block Randomization will be carried out. Primary investigator is blinded in this study. Allocation will be made by co-investigators. They’ll be sent either to control group(spectacles) or intervention group(spectacle+ Varmam therapy group) Then at baseline, participants will undergo a comprehensive eye examination, including visual acuity testing, objective refraction, subjective refraction intra-ocular pressure, contrast sensitivity testing and accommodation assessment. Ocular examination will be done by the optometrist. Best corrected visual acuity for distance will be assessed using the Log MAR visual acuity chart and N notation for near visual acuity, where participants are asked to identify the letters at a specific testing distance. Objective refraction will be accessed with an auto-refractometer/Retinoscope, IOP will be measured using I care tonometer and recorded in mmHg, and accommodation assessment will be done using NPA where a chart is brought near until the patient sees the targeted line as blurred recording of the data will be recorded in diopter units and contrast sensitivity will be measured with Peli Robson chart and recorded in log units. Then the participant will be taken for Varmam therapy sessions, where Participants will receive Varmam therapy sessions, administered by certified siddha practitioners, targeting specific points related to vision and eye health according to traditional practices. Few ocular-related Varmam points are Manipulated in a feather-touch manner. There are total 19 points which will be tapped and the names of the points are as follows Puruva Varmam, Minvetli Varmam, Pueakkadaikkan Varmam, Ago kodaikkon Varmam, Ida moorthi Varmam, Vala Moorthi Varmam, Kanmani Varmam, Thilartha Varmam, Nadamoorthy Varmam, Siriyamandira Varmam, Periyamondisa Varmam and Kondaikolli Varmam, Seesumkolli Varmam, Panchonarambadangol, Suruthi Varmam, Nalchothira Varmam, Poykai Varmam, Pidari Varmam, Nau Varmam. With our experience, Varmam therapy is less likely to produce any side effects. However, in case of any headaches, management will be done by the Siddha experts. The frequency of the therapy is 3 sessions per week for the first month, then weekly one session until 6 months. Each session will last for 10 minutes. Attendance at Varmam therapy sessions will be recorded, and adherence to the intervention protocol will be monitored. Follow-up tests will be conducted at 6 months. All the values which will be noted will be further used for the analysis of the study. If the participant misses an appointment reminder will be given to continue further session. however, Participant who miss 2 continuous session will be considered dropouts. Ocular examinations will be done at baseline(pre therapy),1 month and 6 months (post-therapy). All the procedures will be done for free of cost to the participant. |