| CTRI Number |
CTRI/2025/03/081674 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| 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
|
Effect of Yastimadhwadi Ashchyotana In The Management Of Dry Eye
|
|
Scientific Title of Study
|
Topical Ayurvedic Intervention (Yastimadhwadi Ashchyotana) in the Management of Computer Vision Syndrome Associated Dry Eye: A Pilot Clinical 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 |
Dr Bhanu Ahirwar |
| Designation |
Postgraduate Resident |
| Affiliation |
Government Ayurvedic Collage and Hospital Kadamkuan Patna Bihar |
| Address |
Department Of Shalakya Tantra OPD No 2 Government Ayurvedic Collage and Hospital Kadamkuan Patna Bihar
Patna
BIHAR
800003
India |
| Phone |
9977317561 |
| Fax |
|
| Email |
bhanu96.ahirwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prof Kumari Uma Pandey |
| Designation |
Professor and Head Of Department |
| Affiliation |
Government Ayurvedic Collage and Hospital Kadamkuan Patna Bihar |
| Address |
Department Of Shalakya Tantra OPD No 2 Government Ayurvedic Collage and Hospital Kadamkuan Patna Bihar
Patna
BIHAR
800003
India |
| Phone |
9431646285 |
| Fax |
|
| Email |
umapandey.nipun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhanu Ahirwar |
| Designation |
Postgraduate Resident |
| Affiliation |
Government Ayurvedic Collage and Hospital Kadamkuan Patna Bihar |
| Address |
Department Of Shalakya Tantra OPD No 2 Government Ayurvedic Collage and Hospital Kadamkuan Patna Bihar
Patna
BIHAR
800003
India |
| Phone |
9977317561 |
| Fax |
|
| Email |
bhanu96.ahirwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic Collage and Hospital Kadamkuan Patna Bihar 800003 |
|
|
Primary Sponsor
|
| Name |
Dr Bhanu Ahirwar |
| Address |
Department Of Shalakya Tantra Government Ayurvedic Collage and Hospital Kadamkuan Patna Bihar 800003 |
| 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 Bhanu Ahirwar |
Government Ayurvedic Collage and Hospital Kadamkuan Patna Bihar 800003 |
Department Of Shalakya Tantra OPD No 2 Government Ayurvedic Collage and Hospital Kadamkuan Patna Bihar 800003
Patna
BIHAR |
9977317561
bhanu96.ahirwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee , Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H046||Other changes of lacrimal passages. Ayurveda Condition: SUSHKAKSHIPAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yastimadhwadi Ashchyotana, Reference: Sushrut Uttartantra 10/12, Route: Topical, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 1(drops), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Carboxymethyl cellulose 0.5% | dose - 1 drop
frequency - qid
route - topical
duration - 6 weeks |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients of either gender aged between 12 to 65 years.
b) Patients having minimum three symptoms of Computer Vision Syndrome (Eye strain and
fatigue, Headache, blurred vision, dry and irritated eyes, double vision, redness of eyes,
burning eyes, excessive tearing and photophobia).
c) Minimum 3 hours daily exposure to any type of Video Display Terminals (VDT) for 1 year.
d) Patients able and willing to provide written informed consent.
e) No expectation that subject will be moving out of the area of the study center during the study
period. |
|
| ExclusionCriteria |
| Details |
a) Known allergy to any eye drops.
b) Ocular therapies other than artificial tears.
c) Patients having current ocular infection, laser in situ keratomileusis (LASIK) in the last 3
months, active ocular allergy, contact lens wearer, Meibomian gland dysfunction (MGD) over
grade 2 (the grade is according to the report of the International Workshop on MGD in 2011),
severe blepharitis or obvious inflammation of the eyelid margin, which in the judgment of the
investigator may interfere with the interpretation of the study results.
d) Patients having herpetic eye disease, diabetes, liver diseases, HIV and Hepatitis B and C.
e) Systemic (tetracycline’s and corticosteroids) or topical medications (other than artificial tear
supplements) that could affect tear film or meibomian gland functions will be discontinued
prior to intervention. However, patients will be instructed not to use artificial tear
preparations, 2 hours prior to testing.
f) Pregnancy or lactating mothers.
g) Uncontrolled systemic disease.
h) Hypersensitivity or intolerance to study drugs (intervention or control).
i) Active participation in any type of intervention study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean change from baseline in subjective dry eye symptoms(DESS) and Ocular Surface Disease
Index (OSDI) score at the follow-up and end of treatment visit.
|
day0 day15 day30 day45 day60
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean change in Schirmer test value (tear production) at the follow-up & end of treatment
visit compared with baseline.
Mean change in the Tear Break Up Time (TBUT) (measure of tear film stability) at the followup & end of treatment visit compared with baseline.
The tolerability & safety of Ayurvedic intervention (Yastimadhwadi ashchyotana). |
day0 day15 day30 day45 day60 |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="1"
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 will be conducted to assess the efficacy, safety and tolerability of a topical Ayurvedic ophthalmic intervention (Yastimadhwadi Ashchyotana) in the treatment of Computer Vision Syndrome (CVS) associated dry eye compared to artificial tear eye drops (Carboxy methyl cellulose) 0.5%. the challenges of conventional artificial eye drops, the quest for safe and effective topical preparations for dry eye other than conventional ones has increased. Various topical therapeutic preparations in different forms are described in Ayurveda to treat dry eye conditions but are not in practical use. There is an urgent need to evaluate and validate the efficacy and safety of those preparations on scientific parameters so that an alternative ayurvedic topical ophthalmic preparation could be developed for dry eye conditions. with the help of selective inclusion and exclusion criteria total 30 patient going to be enrolled for the study in also with 10 patient to compensate for dropout . 2 groups will be made in that group 1 is for ayurvedic intervention group and group 2 is control group . study duration will be 60 days . |