| CTRI Number |
CTRI/2025/10/096017 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [CURATIVE] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Study To Evaluate Effectiveness Of Shatavari Ghrita Aaschyotana In Computer Vision Syndrome |
|
Scientific Title of Study
|
Randomized Controlled Clinical Study To Evaluate The Efficacy Of Shatavari Ghrita Aaschyotana In Computer Vision Syndrome (CVS) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DHARMARAJ BHUSHAN BHOITE |
| Designation |
Master of Surgery Ayurveda Dhanwantri ) Shalakya) |
| Affiliation |
L.K.R.Ayurvedic College Gadhinglaj kolhapur |
| Address |
Department Shalakyatantra O.P.D. No.-50 L K R Ayurvedic college And PG Training And Reasearch Center P2 MIDC Area Shendri Mal Gadhinglaj Kolhapur
Gadhinglaj Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9850750992 |
| Fax |
|
| Email |
dharmarajbhoite999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
POONAM BELGAONKAR |
| Designation |
Associate Professor |
| Affiliation |
L.K.R.Ayurvedic College Gadhinglaj kolhapur |
| Address |
Department Shalakyatantra O.P.D.No.-50 L K R Ayurvedic college And PG Training And Reasearch Center P2 MIDC Area Shendri Mal Gadhinglaj Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
08605657046 |
| Fax |
|
| Email |
dr.poonam2785@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DHARMARAJ BHUSHAN BHOITE |
| Designation |
Master Of Surgery Ayurveda Dhanwantri In Shalakya Tantra |
| Affiliation |
L.K.R.Ayurvedic College Gadhinglaj kolhapur |
| Address |
Department of shalakyatantra O.P.D.No.-50,LKR Ayurvedic college and training and research center Gadhinglaj kolhapur
Gadhinglaj Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
09850750992 |
| Fax |
|
| Email |
dharmarajbhoite999@gmail.com |
|
|
Source of Monetary or Material Support
|
| L K R Ayurvedic college and training and research center Gadhinglaj kolhapur pin code -416502 |
|
|
Primary Sponsor
|
| Name |
DHARMARAJ BHUSHAN BHOITE |
| Address |
Department of shalakyatantra LKR Ayurvedic college and training and research center Gadhinglaj kolhapur pin code -416502 |
| 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 |
| DHARMARAJ BHUSHAN BHOITE |
L K R HOSPITAL |
Shalakyatantra O.P.D.No.-50.L K R AYURVEDIC COLLEGE GADHINGLAJ KOLHAPUR -416502
Kolhapur
MAHARASHTRA |
9850750992
dharmarajbhoite999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| L K R AYURVEDIC COLLEGE GADHINGLAJ KOLHAPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H048||Other disorders of lacrimal system. Ayurveda Condition: SUSHKAKSHIPAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatavari Ghrita , Reference: Sharangdhar Samhita , Route: Ocular, Dosage Form: Ghrita, Dose: 5(drops), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -Aashchyotana kalpana hence anupan not applicable | | 2 | Comparator Arm (Non Ayurveda) | | - | Carboxy Methyl cellulose | |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients Suffering From Irritation Strain Burning Sensation Redness Blurred Vision |
|
| ExclusionCriteria |
| Details |
Patients having any other known OCULAR pathology and ocular infections involving glaucoma cataract retinopathy corneal ulcer conjunctivitis uveitis |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy Of Shatavari Ghrita Aashchyotana In Computer Vision Syndrome |
21 days (3 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse Reaction If Any |
21 Days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
31/10/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 randomized open labelled standard controlled prospective clinical study to evaluate the efficacy of shatavari ghrita aashchyotan in computer vision syndrome cvs Total 80 patients of ahe 18 to 50 years of both sex will be randomly selected for this trail and divided into groups. Group A Treated with shatavari ghrita aashchyotan. Adult dose 5 drops in each eye morning and evening for 21 days Group B Treated with sodium carboxy methyl cellulose eye drops. Adult dose 2 drops in each eye morning and evening for 21 days. Data will be analysed and appropriate statistical tests will be applied |