CTRI

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CTRI Number

CTRI/2025/01/079482 [Registered on: 27/01/2025] Trial Registered Prospectively

Last Modified On:

25/01/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Using Mudgaparni medicated Go ghrita Eye Drops to Manage Computer Vision Syndrome

Scientific Title of Study

A Randomized Controlled Clinical Study on Effect of Mudgaparni Siddha Goghrita Aschyotana in Computer Vision Syndrome

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 Sandeep Rawat
Designation	PG Scholar
Affiliation	Bharati Vidyapeeth(Deemed to be University)
Address	Bharati Vidyapeeth(Deemed to be University), College of Ayurved & Hospital,Dhankawadi ,Pune Department of Shalakya Tantra Room number 24 Pune MAHARASHTRA 411043 India
Phone	8511538809
Fax
Email	sandeep.rawat-ayurved@bvp.edu.in

Details of Contact Person
Scientific Query

Name	Dr Santosh Mulik
Designation	Head of Department
Affiliation	Bharati Vidyapeeth (Deemed to be University), College of Ayurved, Pune-43
Address	Bharati Vidyapeeth (Deemed to be University), College of Ayurved, Pune-43 Pune MAHARASHTRA 411043 India
Phone	9823491389
Fax
Email	mulik.santosh@bharatividyapeeth.edu

Details of Contact Person
Public Query

Name	Dr Santosh Mulik
Designation	Head of Department
Affiliation	Bharati Vidyapeeth (Deemed to be University), College of Ayurved, Pune-43
Address	Bharati Vidyapeeth (Deemed to be University), College of Ayurved, Pune-43 Department of Shalakya Tantra Room number 24 Pune MAHARASHTRA 411043 India
Phone	9823491389
Fax
Email	mulik.santosh@bharatividyapeeth.edu

Source of Monetary or Material Support

Bharati Ayurved Hospital, Bharati Vidyapeeth Campus, Dhankawadi, Pune, Maharashtra, India 411043

Primary Sponsor

Name	Dr Sandeep Rawat
Address	Bharati Vidyapeeth(Deemed to be University), College of Ayurved & Hospital, Department of Shalakyatantra,OPD No.-24 Katraj, Dhankawadi , Pune
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Sandeep Rawat	Bharati Ayurved Hospital	Bharati Vidyapeeth (Deemed to be University), College of Ayurved and Hospital, Department of Shalakya Tantra, room number 24, Katraj, Dhankawadi, Pune 411043 Pune MAHARASHTRA	8511538809 sandeep.rawat-ayurved@bvp.edu.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
ETHICS COMMITTEE [BV(DU)COA-EC]	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:H049\|\|Disorder of lacrimal system, unspecified. Ayurveda Condition: SUSHKAKSHIPAKAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm (Non Ayurveda)		-	Carboxymethyl cellulose 0.5% eye drops	Instillation of 2 drops, 3 times a day, both eyes for 30 days
2	Intervention Arm	Drug	Classical		(1) Medicine Name: Mudgaparni Siddha Goghrita, Reference: Ashtang Hridya, Route: Topical, Dosage Form: Ghrita, Dose: 2(drops), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -

Inclusion Criteria

Age From	15.00 Year(s)
Age To	45.00 Year(s)
Gender	Both
Details	1 Patients suffering from Computer Vision Syndrome will be selected 2 Patients will be selected irrespective of gender, socio-economic status and religion.

ExclusionCriteria

Details

1 Any ocular surface pathology.
2 Any ocular disease other than Computer Vision syndrome
3 Patient aged below 15 and above 45 years
4 Congenital anomalies of eye.
5 One eyed patient

Method of Generating Random Sequence

Other

Method of Concealment

Case Record Numbers

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Dryness of eye will be assessed Eye fatigue will be assessed	Dryness and eye fatigue will be assessed on 7th day, 15th day and on 30th day

Secondary Outcome

Outcome	TimePoints
Eye redness will be assessed Burning sensation will be assessed Itching sensation will be assessed Headache will be assessed	Eye redness, burning sensation, itching sensation & headache will be assessed also after 3 months

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
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)

10/02/2025

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 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

This study is a randomised, controlled, open label, parallel group study on effect of

Mudgaparni Siddha Goghrita Aschyotana in Computer Vision Syndrome for 30 days in 30 patients with Computer vision syndrome that will be conducted in Bharati Vidyapeeth (Deemed to be University), College of Ayurved and Hospital, Department of Shalakya Tantra, OPD number 24, Katraj, Dhankawadi, Pune

411043.

The primary outcome measures will be reduction in the Dryness of eye and Eye fatigue. The secondary outcomes will be Reduction in symptoms of Eye redness, Burning

sensation, Itching sensation and Headache.