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CTRI Number  CTRI/2024/08/072651 [Registered on: 19/08/2024] Trial Registered Prospectively
Last Modified On: 11/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative study of efficacy of Honey eye drops and Nephazoline eye drops in management of Hyperemia 
Scientific Title of Study   Randomized controlled clinical trial to study the efficacy of Madhu Aschyotana and Naphazoline eyedrop in management of Sirotpata. 
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 Umeshkumar Suthar 
Designation  MS Scholar Shalakyatantra 
Affiliation  Tilak Ayurveda Mahavidyalaya 
Address  Department of Shalakyatantra 2nd floor Tilak ayurveda Mahavidyalaya 583/2 Rasta Peth

Pune
MAHARASHTRA
411011
India 
Phone  9156825920  
Fax    
Email  umesh.suthar80@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Milind Bhoi 
Designation  Associate Professor Shalakyatantra Department 
Affiliation  Tilak Ayurveda Mahavidyalaya 
Address  Department of Shalakyatantra 2nd floor Tilak ayurveda Mahavidyalaya 583/2 Rasta Peth

Pune
MAHARASHTRA
411011
India 
Phone  9823047544  
Fax    
Email  drmilindbhoi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Umeshkumar Suthar 
Designation  MS Scholar Shalakyatantra 
Affiliation  Tilak Ayurveda Mahavidyalaya 
Address  Department of Shalakyatantra 2nd floor Tilak ayurveda Mahavidyalaya 583/2 Rasta Peth

Pune
MAHARASHTRA
411011
India 
Phone  9156825920  
Fax    
Email  umesh.suthar80@gmail.com  
 
Source of Monetary or Material Support  
Seth Tarachand Ramnath Charitable Ayurvedic Hospital, 580/2, Rasta Peth, Pune- 411011 
 
Primary Sponsor  
Name  Tilak Ayurveda Mahavidyalaya 
Address  Tilak ayurveda Mahavidyalaya 583/2 Rasta Peth Pune 583/2 Rasta Peth Pune 411011 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Umeshkumar Suthar  Seth Tarachand Ramnath Ayurvedic Hospital  Tilak Ayurveda Mahavidyalaya Department of Shalakyatantra Ophthalmology OPD 14 1st floor 583/2 Rasta Peth Pune
Pune
MAHARASHTRA 		 9156825920

umesh.suthar80@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H114||Other conjunctival vascular disorders and cysts. Ayurveda Condition: SIROTPATAH/SIROTPATA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-AScyotanam, आश्च्योतनम् (Procedure Reference: Sushrut Uttartantra 12/15, Procedure details: Instillation of the madhu ,honey ,oil, ghee in the form of drops into the eye from a height of two angulas.)
(1) Medicine Name: Madhu, Reference: Sushrut Sutrastahn 45/132, Route: Ocular, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 10(drops), Frequency: od, Duration: 7 Days
2Comparator Arm (Non Ayurveda)-NephazolineNaphazoline is a medicine used as a decongestant, and a vasoconstrictor added to eye drops to relieve red eye. It has a rapid action in reducing swelling when applied to mucous membranes. It is a sympathomimetic agent with marked alpha adrenergic activity that acts on alpha-receptors in the arterioles of the conjunctiva to produce constriction, resulting in decreased congestion.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Burning Sensation
2. Redness in Eyes
3. Sirajala Darshan
4. Pain or without pain 
 
ExclusionCriteria 
Details  1. Patient with corneal injury, corneal ulcer, iridocyclitis
2. Patient Undergone surgery in past 6 months. 
 
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 symptoms of pain, congestion, burning sensation  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in symptoms of pain, coppery congestion, burning sensation  14 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   23/08/2024 
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   The study will be intervened by the treatment of Madhu Aschyotan and Nephazoline eyedrop to group A and group B respectively. The efficacy of the therapy will be assessed on the basis of subjective criteria for statistical analysis. Scoring will be designed according to the severity of symptoms. The subjective 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. 
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