| CTRI Number |
CTRI/2025/09/094525 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of homoeopathic medicine Belladona 6C versus Euphrasia 6C in management of screen induced eye strain |
|
Scientific Title of Study
|
A single blind, randomized, comparative clinical trial evaluating the effectiveness of homoeopathic remedies Belladona 6C versus Euphrasia 6C in the management of screen induced Asthenopia |
| 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 Aditi Mahendra Deshmukh |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth (Deemed To Be University) Homoeopathic Medical College and Homoeopathic Hospital |
| Address |
Bharati Vidyapeeth (Deemed To Be University) Homoeopathic Medical College and Homoeopathic Hospital, Department of Postgraduate and Research Centre, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9370086082 |
| Fax |
|
| Email |
aditi.deshmukh-hmcpune@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati R Shinde |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed To Be University) Homoeopathic Medical College and Hospital, Pune |
| Address |
Bharati Vidyapeeth (Deemed To Be University) Homoeopathic Medical College and Homoeopathic Hospital, Department of Postgraduate and Research Centre, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9890140393 |
| Fax |
|
| Email |
swati.shinde@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati R Shinde |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed To Be University) Homoeopathic Medical College and Hospital, Pune |
| Address |
Bharati Vidyapeeth (Deemed To Be University) Homoeopathic Medical College and Homoeopathic Hospital, Department of Postgraduate and Research Centre, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9890140393 |
| Fax |
|
| Email |
swati.shinde@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (deemed to be university ) Homoeopathic Medical College and Homoeopathic Hospital, Department of Post Graduates and Research Centre, Pune 411043, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr. Aditi M Deshmukh |
| Address |
Bharati Vidyapeeth (deemed to be university) Homoeopathic Medical College and Homoeopathic Hospital, Department of Postgraduates and Research Centre, Pune. 411043 |
| 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 Aditi Mahendra Deshmukh |
Bharati Vidyapeeth (Deemed To Be University) Homoeopathic Medical College and Hospital Pune 411043 |
Bharati Vidyapeeth (Deemed To Be University) Homoeopathic Medical College and Homoeopathic Hospital Department of Post-Graduate and Research Centre Pune 411043, Maharashtra, India
Pune
MAHARASHTRA |
9370086082
aditi.deshmukh-hmcpune@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth (deemed to be university) Homoeopathic Medical College and Homoeopathic Hospital Department of Post-Graduate and Research Centre Dhankawadi Pune-Satara Road 411043 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H531||Subjective visual disturbances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Belladona 6C |
Belladona 6C 4 pills once a week followed by placebo 4 pills once a day administered by oral route same repeated for 3 months. |
| Comparator Agent |
Euphrasia 6C |
Euphrasia 6C 4 pills once a week followed by placebo 4 pills once a day administered by oral route same repeated for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1 Adults aged 18-40 years of both sexes
2 Participants having eye symptoms because of prolong digital device use having CVS-Q score more than or equal to 6 will only be included irrespective of the use of spectacles
3 Regular digital device users for minimum 5 hours daily for at least 5 days per week |
|
| ExclusionCriteria |
| Details |
1 Pre-existing ocular pathology
2 Use of contact lenses
3 History of ocular surgery within the past year
4 Current treatment with lubricating eye drops or other interventions for DES that cannot be discontinued
5 Systemic conditions that may affect tear production
6 Use of medications known to cause dry eyes
7 Pregnancy or breastfeeding
8 Chronic migraine or chronic headache
9 Below 18 and above 40 years of age |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Improved if the CVS-Q score is less than 6 after the treatment
2. Not improved if CVS-Q score is same or more than the pre-treatment score |
CVS-Q score assessed at baseline, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determine the duration of sustained improvement |
6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
22/09/2025 |
| 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="3"
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
|
Asthenopia commonly referred to as digital eye
strain or computer vision syndrome is an increasingly prevalent
condition associated with prolonged use of digital devices It manifests as
visual discomfort headaches blurred vision dry eyes and reduced visual
efficiency significantly affecting quality of life and occupational
productivity Conventional management primarily involves ergonomic measures and
optical corrections which provide only temporary relief Homoeopathy with its
individualized and holistic approach offers potential as a safe and effective
complementary treatment This single blind randomized comparative clinical
trial is designed to evaluate the effectiveness of two homoeopathic
remedies Belladonna 6C versus Euphrasia 6C in the management of screen induced
asthenopia A total of 30 participants aged 18 to 40 years meeting inclusion
criteria with Computer Vision Syndrome Questionnaire CVS Q scores more than or equal to 6 will be
randomized into two groups Group A receiving Belladonna 6C and Group B
receiving Euphrasia 6C each administered once weekly for three months along
with daily placebo All participants will also receive standardized ergonomic
advice for digital device usage Outcome assessment will be based on changes in
CVS Q scores recorded at baseline and during follow ups every 15 days The
primary objective is to compare the reduction in subjective symptoms between
the two groups Secondary objectives include evaluating improvements in visual
comfort performance during screen related tasks and the duration of sustained
improvement The study seeks to provide clinical evidence regarding the
comparative effectiveness of Belladonna 6C and Euphrasia 6C in screen induced
asthenopia aiming to contribute to the development of a specific therapeutic
protocol in homoeopathic practice for managing digital eye strain |