| CTRI Number |
CTRI/2024/12/077700 [Registered on: 05/12/2024] Trial Registered Prospectively |
| Last Modified On: |
05/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study the effect of Trataka karma & CMC eyedrops in Computer Vision Syndrome in IT Professionals. |
|
Scientific Title of Study
|
A clinical study to evaluate the effect of Trataka karma in Computer Vision Syndrome in Information Technology professionals: A 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 |
Dr Aishwarya Hariram Meshram |
| Designation |
PG Scholar |
| Affiliation |
Guide |
| Address |
Pakwasa Samanvay Rugnalaya, Shri Ayurved Mahavidyalaya, Swasthavritta & Yoga Department, 15, Budhwar bazar, Hanuman nagar, Nagpur- 440024
Pakwasa Samanvay Rugnalaya, Shri Ayurved Mahavidyalaya, Swasthavritta & Yoga Department, 15, Budhwar bazar, Hanuman nagar, Nagpur- 440024
Nagpur
MAHARASHTRA
440024
India |
| Phone |
8830475152 |
| Fax |
|
| Email |
meshramaishwarya06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sapana A Ukey |
| Designation |
Assistant Professor |
| Affiliation |
Shri Ayurved Mahavidyalaya, Nagpur |
| Address |
Swasthavritta & Yoga Department, Pakwasa Samanvay Rugnalaya, Shri Ayurved Mahavidyalaya, Hanuman nagar, Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9890242929 |
| Fax |
|
| Email |
drsapnaukey@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sapana A Ukey |
| Designation |
Assistant Professor |
| Affiliation |
Shri Ayurved Mahavidyalaya, Nagpur |
| Address |
Swasthavritta & Yoga Department, Pakwasa Samanvay Rugnalaya, Shri Ayurved Mahavidyalaya, Hanuman nagar, Nagpur
MAHARASHTRA
440024
India |
| Phone |
9890242929 |
| Fax |
|
| Email |
drsapnaukey@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Ayurveda Mahavidyalaya, Nagpur, Hanuman Nagar, Nagpur Maharashtra, India 440024 |
|
|
Primary Sponsor
|
| Name |
Dr Aishwarya Hariram Meshram |
| Address |
Swasthavritta and Yoga Department, Pakwasa Samanvay Rugnalaya, Shri Ayurveda Mahavidyalaya, Hanuman Nagar, Nagpur, Maharashtra, India 440024 |
| 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 Aishwara Meshram |
Information Technology Firm |
IT park, Nagpur
Nagpur
MAHARASHTRA |
8830475152
meshramaishwarya06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethical Commitee of Shri Ayurved Mahavidyalaya, Nagpur |
Approved |
| Information Technology Firm |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy participants will be screened with the help of Computer Vision Syndrome Questionnaire and Schirmers test and those who will have positive score will be taken as case and control. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Trataka karma | (Procedure Reference: Hathayoga Pradipika 2/31-32 page no. Khemraj Shrikrishnadas Prakashan, Mumbai, Procedure details: Trataka karma will be performed once a day for one month. Madhya Trataka karma will be followed by patients.)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Carboxymethycellulose 0.5% eyedrops | CMC 0.5% eyedrops to be instilled in both the eyes in QID for 1 month. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients working in IT sector with screen time more than 4 hours a day for 3 months with or without the use of any spectacles.
Patients of CVS evaluated by Computer Vision Syndrome Questionnaire with score more than or equal to 6 and Schirmers test with score less than 15. |
|
| ExclusionCriteria |
| Details |
Known hypersensitivity to study medications and those who had used any other topical ophthalmic medications within 14 days (other than tear substitutes).
History of any active ocular infection or allergy or surgery within 12 months or use of any contact lenses.
Patients of Sjogren syndrome and other autoimmune diseases.
Any systemic diseases like uncontrolled HTN or DM or congenital deformities or thyroid abnormalities or renal diseases or cardiac diseases and carcinoma will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the efficacy of Trataka karma in Computer Vision Syndrome based on Computer Vision Syndrome Questionnaire. |
Follow up will be taken on day 15 and 30. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate & compare the efficacy of Trataka karma in Computer Vision Syndrome based on Schirmers test. |
Follow up will be taken on day 15 & 30. |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
16/12/2024 |
| 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 Applicable |
| 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
|
In the present study, total 64 participants will be taken for trial dividing them in 2 equal groups. Group A will receive the trial procedure ’Trataka karma’ and Group B will receive the already proven drug ’CMC 0.5% e/d’ Follow up will be taken on day- 0, 15 and 30. Result will be concluded based on assessment criteria. |