FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/08/072302 [Registered on: 12/08/2024] Trial Registered Prospectively
Last Modified On: 10/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to evaluate efficacy of Masuradi Ghrita Tarpana and Triphala Ghrita along with Eye Exercises in Prathama patalagata timira wsr to Simple myopia 
Scientific Title of Study   An open label randomized controlled clinical study on the evaluation of efficacy of Masuradi Ghrita Tarpana with Ocular Exercises in the management of Prathama Patalagatatimira, Simple Myopia  
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 Aishwarya K  
Designation  Post Graduate Scholar 
Affiliation  Jss Ayurveda Medical College and Hospital 
Address  Room no : 4, Department of shalakya tantra, Jss Ayurveda Medical College and Hospital Lalitadripura Road Mysuru

Mysore
KARNATAKA
570028
India 
Phone  9900510424  
Fax    
Email  draishwaryakarthikeyan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandhya Rani D 
Designation  Professor 
Affiliation  Jss Ayurveda Medical College and Hospital 
Address  Room no : 4, Department of shalakya tantra, Jss Ayurveda Medical College and Hospital Lalitadripura Road Mysuru

Mysore
KARNATAKA
570028
India 
Phone  9448584801  
Fax    
Email  sandhyaranid30@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Dr Sandhya Rani D 
Designation  Professor 
Affiliation  Jss Ayurveda Medical College and Hospital 
Address  Room no : 4, Department of shalakya tantra, Jss Ayurveda Medical College and Hospital Lalitadripura Road Mysuru

Mysore
KARNATAKA
570028
India 
Phone  9448584801  
Fax    
Email  sandhyaranid30@yahoo.in  
 
Source of Monetary or Material Support  
Jss Ayurveda Medical College and Hospital Lalitadripura Road Mysuru 
 
Primary Sponsor  
Name  Dr Aishwarya K 
Address  Jss Ayurveda Medical College and Hospital Lalitadripura Road Mysuru, India, 570028 
Type of Sponsor  Other [Self] 
 
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 Aishwarya K  Jss Ayurveda Medical College and Hospital Lalitadripura Road Mysuru  Room no : 4, Department of shalakya tantra, Jss Ayurveda Medical College and Hospital Lalitadripura Road Mysuru India 570028
Mysore
KARNATAKA 		 9900510424

draishwaryakarthikeyan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committe, JSS Ayurveda Medical College, Mysuru  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H521||Myopia. Ayurveda Condition: PRATHAMA-PATALAGATADOSHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-netratarpaNam, नेत्रतर्पणम् (Procedure Reference: Ashtanga Hridaya Sutrasthana 24, Procedure details: Procedure details: Purvakarma Sthanika Mrudu Abhyanga followed by Mrudu Swedana Pradhanakarma Netra Tarpana with Triphala Ghrita for 18 minutes from Day 1 to 7 Adjuvant Ocular Exercise from Day 1 to 28 Paschatkarma Removing Ghrita & Mashapishti then Mrudu Sweda is given)
(1) Medicine Name: Triphala Ghrita, Reference: Ashtanga Hridaya Uttara Tantra 13, Route: Ocular, Dosage Form: Ghrita, Dose: 200(ml), Frequency: od, Duration: 7 Days
2Intervention ArmProcedure-netratarpaNam, नेत्रतर्पणम् (Procedure Reference: Ashtanga Hridaya Sutrasthana 24, Procedure details: Procedure details: Purvakarma Sthanika Mrudu Abhyanga followed by Mrudu Swedana Pradhanakarma Netra Tarpana with Masuradi Ghrita for 18 minutes from Day 1 to 7 Adjuvant Ocular Exercise from Day 1 to 28 Paschatkarma Removing Ghrita & Mashapishti then Mrudu Sweda is given)
(1) Medicine Name: Masuradi Ghrita, Reference: Vangasena Samhita Netraroga Adhikara 287, Route: Ocular, Dosage Form: Ghrita, Dose: 200(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Subjects aged between 12 to 25 years of age
Subjects having classical symptoms of Prathama Patalagata Timira, Simple Myopia
Subjects prescribed with myopic lens below the power of minus 6 Diopters
Subjects who are Tarpana Yogya
 
 
ExclusionCriteria 
Details  Systemic exclusion like Juvenile Diabetes, Hyperthyroidism.
Subjects who are known cases of Ocular Infections
Subjects who are known cases of abnormalities of corneal curvature like Keratoconus, Keratoglobus, Corneal degeneration.
Subjects who underwent any previous ocular surgery.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in Visual Acuity
Reduction in Antero-posterior diameter of the eyeball (A scan)
 		 28 Days
 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in Blurring of Vision
Reduction in Headache
Reduction in Eye Strain
Reduction in Watering of eye
 		 28 Days
 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   N/A 
Date of First Enrollment (India)   26/08/2024 
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="3"
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   Prathama Patalagata Timira is characterized by Avyakta Darshana (gradual and painless vision deterioration).When observing the different symptoms associated with this condition, Prathama Patalagata Timira can be correlated to Simple Myopia. Myopia  or  shortsightedness  is  a  type  of refractive   error   in   which   parallel   rays   of   light coming  from  infinity  are focused  in  front  of  the retina  when  accommodation  is  at  rest.This results in Blurring of near vision, Headache, Watering of Eyes and Eye Strain. Treatments that are available for simple myopia include spectacle lenses, contact lenses, and pharmaceutical agents. Currently there is no medication available to safeguard the eyesight of individuals with Myopia, nor is there any formulation indicated for maintaining the overall health of the eyes. Surgical interventions come with inherent risks and potential complications, aside from being financially burdensome. On the other hand, Ayurveda has the concept of Chakshushya Dravya which constitutes drugs that maintain the healthy state of eyes and to treat their pathological condition. Also topical ophthalmic therapeutic procedures for eye disorders are described under the term "Kriyakalpa" among which Tarpana is indicated in Timira, and many Ghritas are mentioned for the same. Triphala Ghrita is Chakshushya and Sarva Timirahara according to Acharya Vagbhatta. Masuradi Ghrita is said to be Timirahara by Vangasena and is conducive to all types of Timira. Thus, present research is being undertaken to scientifically study and validate the effect of Masuradi Ghrita Tarpana in comparision with Triphala Ghrita Tarpana with Ocular Exercises in Prathama Patalagata Timira (Simple Myopia). 
Close