| CTRI Number |
CTRI/2024/06/069421 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
18/06/2024 |
| 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
|
A clinical study on the effect of bilvadi eye drop and lauhadi guggulu in computer vision syndrome. |
|
Scientific Title of Study
|
The efficacy of bilvadi eye drop and lauhadi guggulu in the management of computer vision syndrome - an open-label double arm randomized control 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 Anupriya mouriya |
| Designation |
PG Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
5th floor Academic block Department of Shalakya Tantra All India Institute of Ayurveda NH19 Gautampuri Awas Sarita Vihar New Delhi Delhi
South
DELHI
110076
India |
| Phone |
08949631350 |
| Fax |
|
| Email |
anupriyamoria9657@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narayan Bavalatti |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
5th floor Academic block Department of Shalakya Tantra All India Institute of Ayurveda NH19 Gautampuri Awas Sarita Vihar New Delhi Delhi
South
DELHI
110076
India |
| Phone |
9873605708 |
| Fax |
|
| Email |
eyenimi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anupriya mouriya |
| Designation |
PG Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
5th floor Academic block Department of Shalakya Tantra All India Institute of Ayurveda NH19 Gautampuri Awas Sarita Vihar New Delhi Delhi
South
DELHI
110076
India |
| Phone |
08949631350 |
| Fax |
|
| Email |
anupriyamoria9657@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda Mathura road, Gautampuri Awas, Sarita Vihar, New Delhi, Delhi 110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
NH-19, Gautampuri Awas, Sarita Vihar, New Delhi, Delhi 110076 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Anupriya mouriya |
All India Institute of Ayurveda |
OPD No 110 , Department of Shalakya Tantra,Hospital block, 1st floor, Mathura Rd, Gautampuri, Sarita Vihar, New Delhi 110076
South
DELHI |
08949631350
anupriyamoria9657@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All india institute of ayurveda institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H538||Other visual disturbances. Ayurveda Condition: SUSHKAKSHIPAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bilvadi eye drops, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 1(drops), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Lauhadi guggulu, Reference: Bhaishajya Ratnavali , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Unequal quantity of Madhu and Ghrita), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Triphala eye drops, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 1(drops), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Saptamrita lauha, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Unequal quantity of Madhu and Ghrita), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Minimum 3 hours exposure to any type of visual display terminal like desktop, laptop or both daily.
2.Computer users complaining of eye strain, burning eyes, red eyes, dry and irritated eyes, light/glare sensitivity, headache, progressive refractive changes, redness, diplopia
3.Patients having a minimum three symptoms of CVS.
|
|
| ExclusionCriteria |
| Details |
1.Patients not willing to participate in the study.
2.Patients suffering from infectious conditions of the eye like conjunctivitis, dry eye syndrome, scleritis, uveitis, glaucoma, stye, etc.
3.Any fundus pathology like optic atrophy, diabetic retinopathy, hypertensive retinopathy, papilledema etc.
4.Recent history of any surgical intervention to the eye.
5.Persistent contact lens users.
6.Patients suffering from uncontrolled systemic disease under medication.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Improvement in signs and symptoms of computer vision syndrome i.e. Eye strain and burning eyes.
2. The safety parameters of the trial drug will be assessed in RSBK department as per the facility available in the laboratory (physio-chemical parameters of the trial drug).
|
1st day, 15th day and 30th day, 60th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Improvement in other signs and symptoms of computer vision syndrome which are Dry eyes, Blurred vision, Headache, Redness, Diplopia, Irritated eye, slow refocusing, Dizziness, Change in colour perception, Fatigue (Neck/Shoulder/Backache). |
1st day, 15th day and 30th day, 60th day. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
25/07/2024 |
| 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 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
|
PRIMARY OBJECTIVE To evaluate the efficacy of Bilvadi eye drops along with Lauhadi Guggulu orally on ocular symptoms of computer vision syndrome i.e. Eye strain and Burning eyes. SECONDARY OBJECTIVE 1. To evaluate the efficacy of Bilvadi eye drops along with Lauhadi Guggulu orally on other ocular symptoms of computer vision syndrome which are Dry eyes, Blurred vision, Headache, Redness, Diplopia, Irritated eye, slow refocusing, Dizziness, Change in colour perception, Fatigue (Neck/Shoulder/Backache). MATERIAL AND METHODOLOGY STEP-1: The detailed study of the available description on computer vision syndrome will be studied from various Sources of Ayurvedic and Contemporary Ophthalmology. STEP-2: The detailed review of selected drug and authentication of procured drug will be done and drug will be prepared in pharmacy of AIIA if feasible or can be procured from GMP certified pharmaceutical company (The eye drop will be prepared by distillation method which is already standardized and same will be followed). STEP-3: Therapeutic intervention.
Setting – Shalakya Tantra OPD Study design – Open labelled double arm randomized control clinical trial. Groups – 2 groups 1.Group 1-Bilvadi eye drops and Lauhadi Guggulu 2.Group 2- Triphala eye drops and Saptamrit Lauha Randomisation – Computer generated random number table Sample size - 36 patients in each group Assessment on – 0th day, 15th day and 30th day Treatment period- 30 days Follow up – 60th day Duration of trial – 60 days DIAGNOSIS CRITERIA:
1. Subjective parameters. 2.Objective parameter: -Since CVS do not have any objective parameters, following tests will be carried out to rule out cases of Dry Eye Syndrome. Schirmer’s test, Tear film break uptime. ASSESMENT CRITERIA : Suitable scoring criteria will be adopted SUBJECTIVE PARAMETER Eye strain Burning eye Blurred vision Dry eyes Headache Redness Diplopia Irritated eye Slow refocusing Dizziness Change in colour perception Fatigue (Neck/Shoulder/Backache) |