| CTRI Number |
CTRI/2025/07/089925 [Registered on: 01/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing efficacy of Ayurvedic Ardhodaka Godugdha eye drops and Olopatadine 0.1 Percent eye drops in Allergic conjunctivitis in age group 18-70 years. |
|
Scientific Title of Study
|
A randomised controlled trial to study the efficacy of Ardhodaka Godugdha Aschyotana and Olopatadine 0.1 Percent eye drop in vataja netra abhishyanda (allergic conjunctivitis) |
| 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 Neha Shailesh Agrawal |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya Pune |
| Address |
Department of Shalakyatantra Tilak Ayurved Mahavidyalaya Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
7218639916 |
| Fax |
|
| Email |
nehasagrawal9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangeeta Santosh Salvi |
| Designation |
Head of department |
| Affiliation |
Tilak Ayurved Mahavidyalaya Pune |
| Address |
Department of Shalakyatantra Tilak Ayurved Mahavidyalaya Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9822082795 |
| Fax |
|
| Email |
salvisangeeta@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sangeeta santosh Salvi |
| Designation |
Head of department |
| Affiliation |
Tilak Ayurved Mahavidyalaya Pune |
| Address |
Department of Shalakyatantra ,Tilak Ayurved Mahavidyalaya Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9822082795 |
| Fax |
|
| Email |
salvisangeeta@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Seth Tarachand Ramnath Charitable Ayurvedic Hospital, 580/2 Rasta Peth, Pune, 411011,
Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya Pune |
| Address |
Tilak Ayurveda Mahavidyalaya Department of Shalakyatantra 583/2 Rasta Peth Pune 411011 |
| Type of Sponsor |
Private medical college |
|
|
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 Neha Shailesh Agrawal |
Seth Tarachand Ramnath Ayurvedic Hospital Pune |
Tilak Ayurved
Mahavidyalaya, 1st
floor, Kaumarbhritya
department, Rastapeth,
583/2, Pune 411011.
Pune MAHARASHTRA
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
7218639916
nehasagrawal9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethical committe, TAMV pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H101||Acute atopic conjunctivitis. Ayurveda Condition: ABISHYANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Olopatadine 0.1 % eye drops | Olopatadine 0.1 % eye drops . Dose 1 drop BID . Duration 7 days .Route Topical | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ardhodaka Godugdha, Reference: Sushrut samhita ,Uttartantra ,9 th chapter vatabhishyandpratishedhadhyay shloka number 12-13, Route: Topical, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: qid, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 7 Days, Reference: No, Route: NA, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants having any three of the above symptoms mentioned in subjective criteria of vataja netrabhishyanda ( allergic conjunctivitis).
2. Participant having age group of 18-70 years irrespective of their gender, caste, economic status & residence status. |
|
| ExclusionCriteria |
| Details |
1.Patient with known case of corneal oedema, central corneal ulceration.other ocular pathology (e.g. infective conjunctivtis).
2.Participant with known allergic reaction to sulphur drug or under medication for allergic
disorders. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| decrease in pricking pain , congestion and oedema |
3 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| decrease in itching , Eye Discharge , Stiffness of lids |
7 day |
|
|
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)
|
30/07/2025 |
| 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="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
|
The study will be intervened by the treatment of Ardhodaka Godugdha Aschyotana and Olopatadine 0.1% Eye Drop to group A and group B respectively. The efficacy of the therapy will be assessed on the basis of subjective and objective criteria for statistical analysis. Scoring will be designed according to the severity of symptoms. The subjective and objective gradation of symptoms will be done as follows and the intensity of each symptom will be calculated before treatment, after treatment and after follow up. The effect of treatment result will be assessed in regards to clinical signs and symptoms on the basis of grading and scoring system. The signs and symptoms will be assessed by adopting the suitable scoring method. |