| CTRI Number |
CTRI/2025/03/083549 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
EFFECT OF GODUGDHA ( COWS MILK) SHIRODHARA ( POURING A WARM COW MILK ONTO THE FOREHEAD IN A STEADY STREAM ) IN MANAGING COMPUTER VISION SYNDROME |
|
Scientific Title of Study
|
EFFECT OF SHIRODHARA SLOWLY & STEADILY DRIPPING MEDICATED LIQUID & FOREHEAD IN COMPUTER VISION SYNDROME A CASE STUDY |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NEETA PATIL |
| Designation |
Professor |
| Affiliation |
|
| Address |
A/P ISLAMPUR TAL WALWA DIST SANGLI
A/P ISLAMPUR TAL WALWA DIST SANGLI
Sangli
MAHARASHTRA
415409
India |
| Phone |
09975335457 |
| Fax |
|
| Email |
drneetapatil@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NEETA PATIL |
| Designation |
Professor |
| Affiliation |
Loknete Rajarambapu Patil Ayurvedic Medical College ,Hospital ISLAMPUR |
| Address |
A/P ISLAMPUR TAL WALWA DIST SANGLI
OPHTHALMOLOGY OPD SHALAKYATANTRA DEPARTMENT LOKNETE RAJARAMBAPU PATIL AYURVEDIC MEDICAL COLLEGE HOSPITAL PG INSTITUTE & RESEARCH CENTER A/P ISLAMPUR 415409 TAL WALWA DIST SANGLI
Sangli
MAHARASHTRA
415409
India |
| Phone |
09975335457 |
| Fax |
|
| Email |
drneetapatil@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NEETA PATIL |
| Designation |
Professor |
| Affiliation |
LOKNETE RAJARAMBAPU AYURVEDIC MEDICAL COLLEGE HOSPITAL PG CENTER ISLAMPUR DIST SANGLI MAHARASHTRA , SHALAKYATANTRA DEPARTMENT |
| Address |
Ophthalmology OPD, shalakyatantra department Loknete Rajarambapu Patil Ayurvedic Medical College, Hospital PG Institute and Research Center A/P ISLAMPUR TAL WALWA DIST SANGLI
Ophthalmology OPD shalakyatantra department Loknete Rajarambapu Patil Ayurvedic Medical College, Hospital PG Institute and Research Center A/P ISLAMPUR TAL WALWA DIST SANGLI, ,Maharashtra
Sangli
MAHARASHTRA
415409
India |
| Phone |
09975335457 |
| Fax |
|
| Email |
drneetapatil@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| OPHTHALMOLOGY OPD, Shalakyatantra Department , Loknete Rajarambapu Patil Ayurvedic Medical College , Hospital PG Institute & research Center Islampur 415409 India |
|
|
Primary Sponsor
|
| Name |
LOKNETE RAJARAMBAPU AYURVED MEDICAL COLLEGE HOSPITAL PG CENTER ISLAMPUR DIST SANGLI MAHARASHTRA |
| Address |
LOKNETE RAJARAMBAPU AYURVEDIC MEDICAL COLLEGE HOSPITAL PG CENTER ISLAMPUR
PRAKASHNAGAR, SANGLI ROAD ISLAMPUR 415409
DIST SANGLI
INDIA |
| Type of Sponsor |
Private medical college |
|
|
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 NEETA PATIL |
Loknete Rajarambapu Medical College Hospital PG institute And Research Center Islampur |
SHALAKYATANTRA DEPARTMENT OF LOKNETE RAJARAMBAPU AYURVEDIC MEDICAL COLLEGE HOSPITAL PG INSTITUTE AND RESEARCH CENTER ISLAMPUR ,PETH SANGLI ROAD ISLAMPUR 415409 DIST SANGLI MAHARASHTRA ,
Sangli
MAHARASHTRA |
9975335457
-
drneetapatil@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LOKNETE RAJARAMBAPU PATIL AYURVEDIC MEDICAL COLLSLAMPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H578||Other specified disorders of eye and adnexa. Ayurveda Condition: SUSHKAKSHIPAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: godugdha, Reference: Kaiydev Nighantu -Dugdhavarga edited &translated by Prof . Priyawat Sharma&Guruprasad Sharma 1st edition 1979 , published by Chaukhamba oriental waranasi page 341, Route: Topical, Dosage Form: Swaras/ Juice, Dose: 00(NA), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 14 Days, Reference: No, Route: NA, Dosage Form: Swaras/ Juice, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Procedure | - | SIRODHARA | (Procedure Reference: Ganesh krishnGarde, sarthvagbhat, edition 2016, Chaukhamba surbharati Prakashan varansi sutrsathan 22/25 page no 91 Shirodhara procedure, Procedure details: Patient will be treated with shirodhara with Godugdha for 45 min in the morning everyday for 14 days . Milk will be changed every day.)
(1) Medicine Name: godugdha, Reference: . Kaiydev Nighantu -Dugdhavarga edited &translated by Prof . Priyawat Sharma&Guruprasad Sharma 1st edition 1979 , published by Chaukhamba oriental waranasi page 341, Route: Topical, Dosage Form: Swaras/ Juice, Dose: 0(NA), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.pateints using computers more than 1yr, 2. patients irrespective of
refractive error 3. minimum 3 hrs exposure to any type of video
display terminas
|
|
| ExclusionCriteria |
| Details |
1.patients having any other eye diseases, 2.patients
using any other eye medications ,3. history of any
surgical intervention of eye 4.persistent contact lens users 5. Any scalp wound or diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effectiveness of godugdha shirodhara
in Netradaha (burning eyes) Netra klama
-(eye strain) ,Netra Kandu (itching of eye)Avil
darshan (blurred vision) shirshul (headache) ,
greeva, bahu, katishul (neck,shoulder and back
pain), Netra rag (redness of eyes) , accordindg
to mild ,moderate and severe condition before
treatment, within treatment (7 days)and after
treatment (14 days) with clinical examinations and tests |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effectiveness of Godugdha shirodhara in Computer Vision Syndrome with clinical
tests i.e. Shirmmer test and Tear Break up Time
test (Pre and Post Treatment)
14 days
|
14 days |
|
|
Target Sample Size
|
Total Sample Size="138"
Sample Size from India="138"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
07/04/2025 |
| 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="0"
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
|
this study is single case study to evaluate the role of godugdha shirodhara for 45 minutes in the morning everyday for 14 days .in computer vision syndrome which will be conducted in india . the primary outcome is effectiveness of godugdha shirodhara in computer vision syndrome . the seconadary outcome is to find role of treatment in sign and symptoms of computer vision syndrome and any adverse effects of treatment |