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CTRI Number  CTRI/2025/04/085850 [Registered on: 28/04/2025] Trial Registered Prospectively
Last Modified On: 26/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Single Arm Study 
Public Title of Study   kan puravalaiyam for kannerichal 
Scientific Title of Study   A Pilot open labeled clinical trial to determine the therapeutic effect of Kan puravalaiyam Ophthalmic application in the management of Kannerichal Burning eyes in computer vision syndrome  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  N A Adlinnivetha 
Designation  PG Scholar 
Affiliation  National Institute of Siddha 
Address  Room No 14 Department of Puramaruthuvam National Institute of Siddha Tambaram sanatorium Kancheepuram Tamilnadu
Room No 14 Department of Puramaruthuvam National Institute of Siddha Tambaram sanatorium Kancheepuram Tamilnadu
Kancheepuram
TAMIL NADU
600047
India 
Phone  7598657299  
Fax    
Email  adlinufiyabsms3@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  D Periyasami 
Designation  Associate Professor HOD Ic 
Affiliation  National Institute of Siddha 
Address  Room No 14 Department of Puramaruthuvam National Institute of Siddha Tambaram sanatorium Kancheepuram Tamilnadu
Room No 14 Department of Puramaruthuvam National Institute of Siddha Tambaram sanatorium Kancheepuram Tamilnadu
Kancheepuram
TAMIL NADU
600047
India 
Phone  7358481734  
Fax    
Email  sami2011nis@gmail.com  
 
Details of Contact Person
Public Query  
Name  D Periyasami 
Designation  Associate Professor HOD Ic 
Affiliation  National Institute of Siddha 
Address  Room No 14 Department of Puramaruthuvam National Institute of Siddha Tambaram sanatorium Kancheepuram Tamilnadu
Room No 14 Department of Puramaruthuvam National Institute of Siddha Tambaram sanatorium Kancheepuram Tamilnadu
Kancheepuram
TAMIL NADU
600047
India 
Phone  7358481734  
Fax    
Email  sami2011nis@gmail.com  
 
Source of Monetary or Material Support  
Ayothidass Pandithar Hospital National Institute of Siddha Tambaram Sanatorium-600047 Kancheepuram Tamilnadu 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  Room No 14 Department of Puramaruthuvam National Institute of Siddha Tambaram sanatorium Kancheepuram Tamilnadu 
Type of Sponsor  Research institution and hospital 
 
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 N A Adlinnivetha  Ayothidass Pandithar Hospital  Room no 14 Department of Puramaruthuvam National Institute of Siddha Tambaram sanatorium Kancheepuram Tamilnadu Kancheepuram
Kancheepuram
TAMIL NADU 		 7598657299

adlinufiyabsms3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H579||Unspecified disorder of eye and adnexa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Puravalaiyam for Kannerichal  A 5 drugs are mixed with alovera pulp and honey Then placed on around the eye 15 to 30 minutes days 7 to 14  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Presence of burning or stinging sensation
More than 3 hours per day usage of VDUs and more than one year exposure of VDUs
Willing to give blood samples for investigation
Willing to take photographs
Willing to participate in trial and
signing consent by fulfilling the condition  
 
ExclusionCriteria 
Details  Systemic diseases affecting the eyesNeurological and psychiatric disorders
Chemical burns
Pregnancy and lactation
Infectious conditions of the eye like conjunctivitis, scleritis, glaucoma, and blepharitis.
Environmental factors
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The expected outcome may reveal the therapeutic effect of kan puravalaiyam in the management of Kannerichal Burning eyes in computer vision syndrome by reduction in the Ocular discomfort analogue scale
 		 The expected outcome may reveal the therapeutic effect of kan puravalaiyam in the management of Kannerichal Burning eyes in computer vision syndrome by reduction in the Ocular discomfort analogue scale
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 3 
Date of First Enrollment (India)   01/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/06/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
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  

Siddha system of medicine is one of the oldest traditional medical systems in the world emphasizes a holistic approach to health by physical mental and spiritual well being with unique diagnostic methods therapeutics and treatment procedures The medicines in Siddha are classified into Agamarunthugal Internal medicines and Puramarunthugal External medicines The External medicine includes external application of medicine external therapy surgical and Para surgical procedures Kan puravalaiyam is one among the Puramarunthugal in which the medicine is applied to the eyes This procedure cools lubricates and rejuvenates the eyes

In Agathiyar aayul vedham 1200 it is mentioned that Kadukkai Terminalia chebula Nelli paruppu Phyllanthus emblica Puliyam kolunthu Tamarindus indica Sadhakuppai Anethum graveolens  Katralai saaru Aloebarbadensis Thean Honey can be used as kan puravalaiyam for burning sensation.

Computer Vision Syndrome CVS also known as Digital Eye Strain is a growing concern in the digital era due to prolonged screen exposure One of the most common symptoms of CVS is a burning sensation in the eyes often accompanied by dryness irritation and fatigue This condition arises due to factors such as reduced blinking improper lighting and prolonged focus on digital screen

While conventional treatments focus on artificial tears ergonomic adjustments and lifestyle modifications traditional Siddha medicine offers holistic and natural remedies Siddha ophthalmic application formulated with herbal extracts and mineral preparations have been traditionally used to soothe eye discomfort reduce inflammation and enhance ocular health

This study explores the efficacy of Puravalaiyam ophthalmic applications in alleviating the burning sensation associated with Computer Vision Syndrome By integrating traditional wisdom with modern scientific analysis  the research aims to provide a natural and sustainable approach to managing digital eye strain

OBJECTIVE

 To evaluate the therapeutic effect of kan puravalaiyam in the management of Kannerichal Burning eyes in computer vision syndrome by assessing the reduction in the Ocular discomfort analogue scale ODAS

STUDY DESIGN

 A pilot open labeled clinical trial with a total number of 30 diagnosed patient of kannerichal reporting at Ayothidass Pandithar hospital National Institute of Siddha will be enrolled in the study patients having systemic diseases neurological diseases psychiatric illnesses chemical burns conjunctivitis and environmental factors will be excluded The trial procedure Puravalaiyam will be given for 14 days

 
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