| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Simple Myopia |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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. )
| | 2 | Comparator Arm | Procedure | - | 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. |