| CTRI Number |
CTRI/2025/04/085610 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
13/04/2025 |
| 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
|
Randomized Clinical Trial to see effects of Yastimadhu Arka eye drop in managing the symptoms of Vataj Abhishyanda (simple allergic conjunctivitis) in comparison to Olopatadine 0.1% eye drop |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial on Comparison of Yastimadhu Arka Eye Drop with Olopatadine 0.1% Eye Drop in Vataj Abhishyanda (Simple Allergic Conjunctivitis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chirag Parmar |
| Designation |
PG scholar in Shalakyatantra |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre. |
| Address |
OPD NO 6 Department of Shalakyatantra Dr D Y Patil College of Ayurved and Research Centre.
Pune
411018
Maharashtra
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9657652876 |
| Fax |
|
| Email |
chirag106258@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayur Shiralkar |
| Designation |
HOD and Professor in Shalakyatantra Department |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre. |
| Address |
OPD NO 6 Department of Shalakyatantra Dr D Y Patil College of Ayurved and Research Centre.
Pune
411018
Maharashtra
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9422007951 |
| Fax |
|
| Email |
mayur.shiralkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chirag Parmar |
| Designation |
PG scholar in Shalakyatantra |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre. |
| Address |
OPD NO 6 Department of Shalakyatantra Dr D Y Patil College of Ayurved and Research Centre.
Pune
411018
Maharashtra
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9657652876 |
| Fax |
|
| Email |
chirag106258@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College of Ayurved and Research Centre. |
|
|
Primary Sponsor
|
| Name |
Dr D Y Patil College of Ayurved and Research Centre. |
| Address |
OPD NO 6 Dr D Y Patil College of Ayurved and Research Centre.
Pune
411018
Maharashtra
India |
| Type of Sponsor |
Other [College of Ayurved and Research Centre.] |
|
|
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 Chirag Parmar |
Dr D Y Patil Ayurved College , Hospital and Research Centre. |
OPD NO 6 Department of Shalakyatantra Dr D Y Patil College of Ayurved and Research Centre.
Pune
411018
Maharashtra
India
Pune
MAHARASHTRA |
09657652876
chirag106258@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR. DYPCA AND RC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H101||Acute atopic conjunctivitis. Ayurveda Condition: VATABISHYANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Yastimadhu Arka eye drop , Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(drops), Frequency: qid, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 5 Days, Reference: NA, Route: -, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Olopatadine 0.1/% eye drop , Reference: Anti-histamine eye drop, Route: Topical, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 1(drops), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 5 Days, Reference: No, Route: -, 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 |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from symptoms of pricking pain , lacrimation , friction of eyelids and signs like congestion and papillae of conjunctiva. |
|
| ExclusionCriteria |
| Details |
Patients suffering from any other ocular pathology like bacterial conjunctivitis , other types of allergic conjunctivitis , corneal opacity , dacryocystitis and tumors of eye . |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Yastimadhu Arka eye drop in reducing the symptoms of Vataja Abhishyanda(simple allergic conjunctivitis) |
The assessment of the patient will be done on day 1 , after which the intervention will be provided . Follow up will be taken after 3rd day and finally on 6th day . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Standardisation of Yastimadhu Arka eye drop . |
The Secondary outcome will be achieved in 6 weeks after CTRI registration is done . |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
24/04/2025 |
| 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="6"
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
|
Aim :- To study the efficacy of Yastimadhu Arka Eye drop in the management of Vataja Abhishyanda (Simple Allergic Conjunctivitis).
Sample size - 35 in each arm
Duration of study :- 5 days
Assesment Day - Day 1
Follow up - 3rd and 6th day
The Final conclusion will be drawn on the basis of the statistical analysis based on the observations and result would be interpreted accordingly . |