| CTRI Number |
CTRI/2026/01/102210 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
24/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Assess the Effect of an Ayurvedic Eye Application in Corneal Opacity. |
|
Scientific Title of Study
|
A Single Arm Clinical Study On Efficacy Of Bibhitakasthi Majja And Madhu Anjana
In Avrana Shukra With Special Reference To Nebular Corneal Opacity. |
| 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 Kamini V Athelkar |
| Designation |
PG Scholar |
| Affiliation |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and L K Ayurved Rugnalaya Yavatmal |
| Address |
Dayabhai mavaji majitiya ayurved Mahavidyalaya Yavatmal affiliated with L.K ayurved rugnalaya yavatmal Department of Shalakyatantra Ground floor Opd no : 16 yavatmal
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
8390542450 |
| Fax |
|
| Email |
kaminiathelkar98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harshal R Deshmukh |
| Designation |
Professor |
| Affiliation |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and L K Ayurved Rugnalaya Yavatmal |
| Address |
Dayabhai mavaji majitiya ayurved Mahavidyalaya Yavatmal affiliated with L.K ayurved rugnalaya yavatmal Department of Shalakyatantra Ground floor Opd no : 16 yavatmal
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9623945057 |
| Fax |
|
| Email |
drharshd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshal R Deshmukh |
| Designation |
Professor |
| Affiliation |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and L K Ayurved Rugnalaya Yavatmal |
| Address |
Dayabhai mavaji majitiya ayurved Mahavidyalaya Yavatmal affiliated with L.K ayurved rugnalaya yavatmal Department of Shalakyatantra Ground floor Opd no : 16 yavatmal
MAHARASHTRA
445001
India |
| Phone |
9623945057 |
| Fax |
|
| Email |
drharshd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and L K Ayurved Rugnalaya Yavatmal
Shivajinagar Arni Road Yavatmal Maharashtra India 445001 |
|
|
Primary Sponsor
|
| Name |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and L K Ayurved Rugnalaya Yavatmal |
| Address |
Dayabhai mavaji majitiya ayurved Mahavidyalaya Yavatmal affiliated with L.K ayurved rugnalaya yavatmal 445001 Maharashtra India |
| 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 Kamini Athelkar |
Lakshmanrao Kalaspurkar Ayurved Rugnalaya Yavatmal |
Dayabhai mavaji majitiya ayurved Mahavidyalaya Yavatmal affiliated with L.K ayurved rugnalaya yavatmal Department of Shalakyatantra Ground floor Opd no : 16 Yavatmal MAHARASHTRA 445001
Yavatmal
MAHARASHTRA |
8390542450
kaminiathelkar98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee DMM Ayurved Mahavidyalaya Yavatmal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H178||Other corneal scars and opacities. Ayurveda Condition: AVRANASUKRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bibhitakasthi Majja And Madhu Anjana, Reference: Ashtang Sangraha , Route: Ocular, Dosage Form: Kalka/ Paste , Dose: 1.4(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients diagnosed as per diagnostic criteria.
2.Patient willing to take part in 15 days of treatment.
3.Patient having age group of 21 to 60 yrs, irrespective of gender, nationality, economic status, religious status. |
|
| ExclusionCriteria |
| Details |
1.Corneal opacity grade other than Nebular.
2.Patient not willing for clinical trial.
3.Corneal opacity with other complications like adherent leucoma, corneal facet, kerectasia, anterior staphyloma.
4.Contraindications for Anjana.
5.Corneal ulcer
6.Patient having systemic diseases like diabetes hypertension, malignancy etc. also acute infections disease. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Netrastrav
2.Length of opacity |
0th,7th,15th,30th,40th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Visual acuity or visual impairement If pupillary area is involved
2.Density of opacity |
0th,40th |
|
|
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)
|
01/04/2026 |
| 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
|
This single-arm clinical study was conducted to evaluate the efficacy of Bibhitakasthi Majja and Madhu Anjana in the management of Avrana Shukra, with special reference to nebular corneal opacity. Patients diagnosed with Avrana Shukra were treated using the selected Ayurvedic formulations, and their clinical outcomes were assessed before and after intervention. The study focused on improvements in corneal clarity, visual acuity, and associated ocular symptoms. The results suggest that Bibhitakasthi Majja and Madhu Anjana have a beneficial role in reducing nebular corneal opacity and improving visual function, indicating their potential effectiveness as a conservative Ayurvedic therapeutic approach in Avrana Shukra. |