| CTRI Number |
CTRI/2025/03/081558 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
02/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To check the effect of Haridradi Anjan application in patients with complaints of Simple Allergic Conjunctivitis |
|
Scientific Title of Study
|
Randomized control clinical trial to evaluate the efficacy of Haridradi Anjan in Vataja Abhishyanda w.s.r. to Simple 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 Pragati Audumbar Sarvade |
| Designation |
MS Shalakyatantra Scholar |
| Affiliation |
LKR Ayurvedic Mahavidyalaya Post Graduate Training and Research Center, Gadhinglaj, Kolhapur |
| Address |
Shalakyatantra department
1 st floor
OPD no 49
Late Kedari Redekar Ayurvedic mahavidyalay Gadhinglaj
P2 M I D C Area, shendri Mal, Gadhinglaj, Kolhapur
Pune
MAHARASHTRA
410501
India |
| Phone |
9763654187 |
| Fax |
|
| Email |
sarvadepragati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yuvraj Sutar |
| Designation |
MS Shalakyatantra |
| Affiliation |
LKR Ayurvedic Mahavidyalaya Post Graduate Training and Research Center, Gadhinglaj, Kolhapur |
| Address |
Shalakyatantra department
1 st floor
OPD no 49
Late Kedari Redekar Ayurvedic mahavidyalay Gadhinglaj
P2 M I D C Area, shendri Mal, Gadhinglaj, Kolhapur
Shalakyatantra department
1 st floor
OPD no 49
Late Kedari Redekar Ayurvedic mahavidyalay Gadhinglaj
P2 M I D C Area, shendri Mal, Gadhinglaj, Kolhapur
Kolhapur
MAHARASHTRA
416505
India |
| Phone |
9850544418 |
| Fax |
|
| Email |
drsutaryuvrajmsophth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pragati Audumbar Sarvade |
| Designation |
MS Shalakyatantra Scholar |
| Affiliation |
LKR Ayurvedic Mahavidyalaya Post Graduate Training and Research Center, Gadhinglaj, Kolhapur |
| Address |
Shalakyatantra department
1 st floor
OPD no 49
Late Kedari Redekar Ayurvedic mahavidyalay Gadhinglaj
P2 M I D C Area, shendri Mal, Gadhinglaj, Kolhapur
Pune
MAHARASHTRA
410501
India |
| Phone |
9763654187 |
| Fax |
|
| Email |
sarvadepragati@gmail.com |
|
|
Source of Monetary or Material Support
|
| Late Kedari Redekari Ayurvedic Mahavidyalaya P.G. Gadhinglaj, P-2, M.I.D.C. Area Shendri Mal, Gadhinglaj |
|
|
Primary Sponsor
|
| Name |
Dr Pragati Audumbar Sarvade |
| Address |
Shalakyatantra department
1 st floor
OPD no 49
Late Kedari Redekar Ayurvedic mahavidyalay Gadhinglaj |
| 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 Pragati Audumbar Sarvade |
LKR Ayurvedic Mahavidyalaya Gadhinglaj |
LKR Ayurvedic Mahavidyalaya P.G. Gadhinglaj,P-2,M.I.D.C. Area Shendri Mal Gadhinglaj Dist-Kolhapur.
Shalakyatantra department 1st Floor OPD No.49
Kolhapur
MAHARASHTRA |
9763654187
sarvadepragati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LKR Ayurvedic College, Gadhinglaj, Kolhapur |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haridradi Anjan , Reference: Yogaratnakar , Route: Ocular, Dosage Form: , Dose: 2(NA), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: Haridradi Anjan will be used in vataja Abhishyanda w.s.r. to simple allergic conjunctivitis in the doses of 2 Harenu matra. | | 2 | Comparator Arm (Non Ayurveda) | | - | Olopatadine eye drop (0.1%w/v) | Olopatadine eye drop belongs to a group of medicines called antihistamine.It is indicated for the symptomatic treatment of ocular itching associated with allergic conjunctivitis as ophthalmic solution. Dose- 2 Drops
Frequency-BD (Morning and Evening)
Route- Ocular
Days- 21 Days
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age group - 18 to 50 years
The patients presenting classical signs and symptoms of Vataja Abhishyanda |
|
| ExclusionCriteria |
| Details |
Patients having any other known ocular pathology.
Any past or present history of ocular trauma.
Patients with K/C/O Naso lacrimal duct block/ Dacryocystitis) |
|
|
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 Evaluate the Efficacy of Haridradi Anjan in Vataja Abhishyanda w.s.r. to Simple Allergic conjunctivitis. |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse reaction if any |
21 days |
|
|
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 |
|
Date of First Enrollment (India)
|
13/03/2025 |
| 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
|
This study is single blind randomized control clinical study to evaluate the efficacy of Haridradi Anjan in Simple Allergic Conjunctivitis. Total 60 patients of age 18 to 50 years of both sex will be randomly selected for this trial and divided into two groups. Group A Haridradi Anjan Dose- 2 Harenu in the evening for 21 days Group B Olopatadine eye drop Dose- 2 Drops in the morning and evening for 21 days |