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CTRI Number  CTRI/2025/07/091062 [Registered on: 17/07/2025] Trial Registered Prospectively
Last Modified On: 03/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the effect of tarpan with viddhakarma in simple myopia  
Scientific Title of Study   A Randomized Comparative Clinical Trial to evaluate an add on effect of Viddhakarma with Goghrita Tarpan in management of 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 VAISHNAVI NANDAKUMAR KUSARE 
Designation  Pg Scholar  
Affiliation  PDEAs college of ayurved and research centre  
Address  PDEAS College of Ayurved and Research Centre third floor shalakyatantra department sector no. 25 pradhikaran Nigadi Pune
PDEAS College of Ayurved and Research Centre third floor shalakyatantra department sector no. 25 pradhikaran Nigadi Pune
Pune
MAHARASHTRA
411044
India 
Phone  7038726522  
Fax    
Email  kusarevaishnavi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chandana Virkar  
Designation  HOD and Professor of Shalakyatantra Department  
Affiliation  PDEAs college of ayurved and research centre  
Address  PDEAS College of Ayurved and Research Centre third floor shalakyatantra department sector no. 25 pradhikaran Nigadi Pune
PDEAS College of Ayurved and Research Centre third floor shalakyatantra department sector no. 25 pradhikaran Nigadi Pune
Pune
MAHARASHTRA
411044
India 
Phone  9822199107  
Fax    
Email  drvirkarchandana@gmail.com   
 
Details of Contact Person
Public Query
 
Name  Dr VAISHNAVI NANDAKUMAR KUSARE 
Designation  Pg Scholar  
Affiliation  PDEAs college of ayurved and research centre  
Address  PDEAS College of Ayurved and Research Centre third floor shalakyatantra department sector no. 25 pradhikaran Nigadi Pune
PDEAS College of Ayurved and Research Centre third floor shalakyatantra department sector no. 25 pradhikaran Nigadi Pune
Pune
MAHARASHTRA
411044
India 
Phone  7038726522  
Fax    
Email  kusarevaishnavi@gmail.com  
 
Source of Monetary or Material Support  
PDEAS College of Ayurved and Research Center nigdi pune 
 
Primary Sponsor  
Name  PDEAS CARC , Nigadi, Pune  
Address  PDEAs College Of Ayurved And Research Centre Shalakyatantra Department Third Floor Nigdi Pune Maharashtra 411044 India 
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 VAISHNAVI NANDAKUMAR KUSARE   Ayurved Rugnalaya And Snowbell Multi Speciality hospital Nigadi Pune   Sector no 27,Shalakyatantra OPD no 122, Pradhikaran Nigadi,Pune, Maharashtra
Pune
MAHARASHTRA 
7038726522

kusarevaishnavi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PDEAS INSTITUTIONAL ETHICAL COMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Simple Myopia  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Viddhakarma (Procedure Reference: तिमिराक्षिपाकप्रभुतिष्वक्ष्यामयेषुपनासिके ललाट्यामापाड्या वा एता एव च शिरोरोगा अधिमन्थप्रभुतिषु रोगेष्विति । (सु.शा.8/16), Procedure details: The area will be cleaned with a spirit solution swab. With 26½ number needle, held perpendicular to the site of Vedhan, a gentle prick of 1.5-2.5 mm deep i.e. ardhavrihi pramana will be made at Lalat & both Apanga. )
2Comparator ArmProcedure-Tarpana (Procedure Reference: Sharangadhar , madhyam khanda , 13/38, Procedure details: Pt will be placed in supine position. Snehana & swedana will be done locally around the eyes followed by application of tarpan goggle which will be filled with lukewarm goghrita. Pt. will be asked to blink the eye for 10-15 min. After specified time goghrita will be removed & eyes will be cleaned)
(1) Medicine Name: Goghrita, Reference: Sushruta sutrasthan 45/97, Route: Topical, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Duration: 5 Days
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1. The patient within age group of 10 to 35 years irrespective of their gender, socio-economic status and religion having symptoms of Myopia
2. Details Subject clinically diagnosed as Myopia
(Refractive error in between Spherical-0.50 to -03.00 Cylindrical upto -1.00 D) 
 
ExclusionCriteria 
Details  1. Subject with any other ocular pathology e.g. cataract, corneal opacity, glaucoma, iridocyclitis, Retinal detachment, Macular scar etc.
2. Any previous eye surgery.
3. K/C/O-Any major systemic disease like Hypertension, Diabetes etc.
4. One Eyed Patient
5. K/C/O any bleeding disorders and patient who is taking Anticoagulants. 
 
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 
To evaluate the add on effect of Viddhakarma with Goghrita Tarpan on Blurring of Vision in Simple Myopia within duration of 30 days.  30 days. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the add on effect of Viddhakarma with Goghrita Tarpan on symptoms other than Blurring of Vision in Simple Myopia within duration of 30 days.
To observe and compare adverse effects if any. 
30 days  
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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)   01/08/2025 
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="0"
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   Myopia is refractive error in which parallel rays of light from an infinity enters the eye and is focused in front of retina, when accommodation is at rest. In modern science, depending on the degree of myopia there is need to wear spectacles or contact lenses all the time. Spectacles or Contact lenses are used to correct refractive error but it neither cures nor prevents the progression of pathology of disease.

Considering all the facts there is a need to have effective and satisfactory drug. According to Ayurveda Samhitas, Timira is Aushadha Sadhya Vyadhi. We can correlate sign and symptom of Myopia with Timir.

Acharya Sushruta describes Drishtigat rogas which are 12

Timira is pratham patalashrit vyadhi. According to Acharya Vagbhata prathama and dwitiya patalgat dosha dushti is known as Timira whereas Tritiya Patalagata Dosha Dushti is known Kacha and chaturth Patalagata dosh Dushti is known as Lingnash

When the vitiated Doshas Invades first Patala, the patient complains of blurred vision or difficulty to see distant Objects which can be related with symptoms of Myopia.

Generally, myopia occurs in school-age children. Because the eye continues to grow during childhood, it typically progresses until average age of 20.

As it affects the young generation it can affect education, personality, self development, confidence and career opportunities that interferes quality of life.

Myopia even of mild degree shuts the door of military, navy or pilot schools, for thousands of young people who dream of such professions.

In Post- Covid days there is significant increase in Cases of Myopia.

Due to the significance of myopia as a global public health concem, it was chosen as a priority.

The Ayurvedic science can be explored to serve a better alternative to manage this condition. In Ayurveda many medical remedies are prescribed for Timira and various herbal preparations for improving visual acuity. So there is a possibility to evolve a new remedy from Indian Medicinal System particularly for Timira with special reference to myopia.

The researches in Ayurveda are being carried out in different institutions all over India with special attention to Timira and also to myopia. The present study is aiming to evaluate the an add on effect of Viddhakarma with Goghrita Tarpan in management of Simple Myopia. 
 
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