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CTRI Number  CTRI/2025/04/085700 [Registered on: 25/04/2025] Trial Registered Prospectively
Last Modified On: 08/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [LOCAL THERAPY AND INTERNAL MEDICATIONS]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Eye Drops For Near Vision Impairment 
Scientific Title of Study   A Comparative clinical study to evaluate The Efficacy Of Vrisha Ghrita And Anantadi Ghrita Aschotana And Pana in the Management Of Dwitiya Patalagata Timira (Presbyopia) 
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 Bhargavi Joshi 
Designation  PG Scholar 
Affiliation  SDM College Of Ayurveda And Hospital Hassan 
Address  Department of Shalakya Tantra 4th floor SDM College Of Ayurveda And Hospital BM Road Thanniruhalla Hassan

Hassan
KARNATAKA
573201
India 
Phone  9481013593  
Fax    
Email  pg23173@sdmcahhassan.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Gururaj Anil Bhat 
Designation  Associate Professor 
Affiliation  SDM College Of Ayurveda And Hospital Hassan 
Address  Department of Shalakya Tantra 4th floor SDM College Of Ayurveda And Hospital BM Road Thanniruhalla Hassan

Hassan
KARNATAKA
573201
India 
Phone  9880856916  
Fax    
Email  drgururajanilbhat@sdmcahhassan.org  
 
Details of Contact Person
Public Query  
Name  Dr Gururaj Anil Bhat 
Designation  Associate Professor 
Affiliation  SDM College Of Ayurveda And Hospital Hassan 
Address  Department of Shalakya Tantra 4th floor SDM College Of Ayurveda And Hospital BM Road Thanniruhalla Hassan

Hassan
KARNATAKA
573201
India 
Phone  9880856916  
Fax    
Email  drgururajanilbhat@sdmcahhassan.org  
 
Source of Monetary or Material Support  
OPD no-13 SDM College of Ayurveda and Hospital BM Road Thanniruhalla Hassan Karnataka- 573201 India 
 
Primary Sponsor  
Name  SDM College of Ayurveda and Hospital 
Address  OPD No-13 Sdm College of Ayurveda and Hospital BM Road Thanniruhalla Hassan-573201 Karnataka 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 Bhargavi Joshi  SDM College of Ayurveda and Hospital  SDM College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
Hassan
KARNATAKA 		 9481013593

pg23173@sdmcahhassan.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College Of Ayurveda and Hospital, Thanniruhalla Hassan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H538||Other visual disturbances. Ayurveda Condition: TIMIRAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-AScyotanam, आश्च्योतनम् (Procedure Reference: Sushruta Samhita , Procedure details: The patient will be made to lie down in the supine position. Eyes will be opened with the left hand & the medicated drops will be held in the right hand just two Angula above the Kaninika Sandhi (inner canthus). 10 bindu prescribed ghrita is put into each eye. After that the eyes should be wiped with soft cloth.)
(1) Medicine Name: Anantadi Ghrita, Reference: Chikitsa Manjari , Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 10(drops), Frequency: od, Duration: 7 Days
2Intervention ArmDrugClassical(1) Medicine Name: Anantadi Ghrita, Reference: Chikitsa Manjari, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushna Jala), Additional Information: Patient Will Take Pana of Anantadi Ghrita Along With Aschotana Of Anantadi Ghrita But Aschotana Will Be Done Only For 7 Days
3Intervention ArmProcedure-AScyotanam, आश्च्योतनम् (Procedure Reference: Sushruta Samhita, Procedure details: The patient will be made to lie down in the supine position. Eyes will be opened with the left hand & the medicated drops will be held in the right hand just two Angula above the Kaninika Sandhi (inner canthus). 10 bindu prescribed ghrita is put into each eye. After that the eyes should be wiped with soft cloth.)
(1) Medicine Name: Vrisha Ghrita, Reference: Sahasrayoga, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 10(drops), Frequency: od, Duration: 7 Days
4Intervention ArmDrugClassical(1) Medicine Name: Vrisha Ghrita, Reference: Sahasrayoga, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushna Jala), Additional Information: Patient Will Take Pana of Anantadi Ghrita Along With Aschotana Of Anantadi Ghrita But Aschotana Will Be Done Only For 7 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients presenting with the symptoms of Dwitiya Patalagata Timira (Presbyopia)  
 
ExclusionCriteria 
Details  1) Patients who are Diabetic, ID +ve and HbsAg +ve, and any other systemic disorders. 2) Patients with other Ocular Pathologies like Cataract, Corneal Opacity, optic atrophy, diabetic retinopathy, hypertensive retinopathy, papilledema, and any other refractive errors.  
 
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 
Improvement in Near Vision, Reduction In The Aesthenopic Symptoms  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Patient Can Read Without Spectacles  30 days 
Reduction In The Aesthenopic Symptoms   
 
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)   05/05/2025 
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="6"
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  

SUMMARY OF SYNOPSIS WORK

 

1.TITLE OF DESSERTATION-  : COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF VRISHA GHRITA AND ANANTADI GHRITA ASCHOTANA AND PANA IN THE MANAGEMENT OF DWITIYA PATALA GATA TIMIRA (PRESBYOPIA

 

2.STUDENT NAME-           

                                                  DR. BHARGAVI JOSHI

                                      PRELIMINARY M S (AYU) SCHOLAR

DEPARTMENT OF SHALAKYA TANTRA

SRI DHARMASTHALA MANJUNATHESHWARA

                            COLLEGE OF AYURVEDA AND HOSPITAL, HASSAN

 

3.GUIDE NAME-

    Dr. GURURAJ ANIL BHAT  MS (Ayu)

ASSISTANT PROFESSOR

DEPARTMENT OF SHALAKYA TANTRA

SRI DHARMASTHALA MANJUNATHESHWARA

COLLEGE OF AYURVEDA AND HOSPITAL, HASSAN


5. AIM OF STUDY- TO EVALUATE THE EFFICACY OF VRISHA GHRITA AND ANANTADI GHRITA ASCHOTANA AND PANA IN THE MANAGEMENT OF DWITIYA PATALA GATA TIMIRA (PRESBYOPIA)

 

6.OBJECTIVE OF STUDY-

·         To evaluate the efficacy of Vrisha Ghrita Aschotana and pana in the management of Dwitiya patalagata Timira w.s.r to Presbyopia

·         To evaluate the efficacy of Anantadi Ghrita Aschotana and pana in the management of Dwitiya patalagata Timira w.s.r to Presbyopia

To compare the efficacy of Vrisha Ghrita and Anantadi Ghrita Aschotana and Pana in the management of Dwitiya patalagata Timira w.s.r to Presbyopia


7.METHODOLOGY-

 

     I.            STUDY PERIOD-30 DAYS

 

  II.            SOURCE OF DATA:

                           40 Patients will be selected from Out-patient department and In-patient Department of Shalakya Tantra, Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital, Hassan.

III.            DIAGNOSTIC CRITERIA:

1. Clinical features of Dwitiya Patalagata Timira or Presbyopia

2. Visual Acuity test with the help of Snellen’s Near vision Chart for the near vision


     I.            SUBJECTIVE PARAMETER

1) Samipastha Avyakta Darshana

     2) Netrayaasa

           3) Netrasrava

           4) Shirashoola

 

   OBJECTIVE PARAMETER

1) Near vision reading

2) Manual refraction

  II.            INCLUSION CRITERIA:

1)      Participants of either gender having  the age of above 30 and below 70 years.

2) Patients presenting with the symptoms of Dwitiya Patalagata Timira / Presbyopia

 

III.            EXCLUSION CRITERIA:

 

  1) Patients who are Diabetic, ID +ve and HbsAg +ve, and any other systemic disorders.

2) Patients with other Ocular Pathologies like Cataract, Corneal Opacity, optic atrophy, diabetic retinopathy, hypertensive retinopathy, papilledema, and any other refractive errors.


VII.PROCEDURE METHODOLOGY:

 

Purva karma-Detail procedure  of Aschotana is explained to participant and Consent is taken for the procedure.Vrisha Ghrita/Anantadi Ghrita is taken in Gokarnika and made lukewarm by keeping in the hot water bath and kept ready.

Pradhana karma – The patient will be made to lie down in the supine position in a room devoid of wind and light. Eyes will be opened with the left hand and the medicated drops will be held in the right hand just two Angula  above the Kaninika Sandhi (inner canthus). 10 bindu of prescribed Ghrita is put into each eye. After that the eyes should be wiped with soft cloth. The patient is advised to take 30ml of the prescribed Ghrita internally in two divided doses, that is, 15ml twice a day before food.

Paschat karma- Patient is advised to follow pathya diet and to avoid dust, breeze and smoke.

Follow up:  Patient is advised to follow-up on 45th day from day of study.


VIII.ASSESSMENT CRITERIA

·         Will be done on grading scale and assessed on the basis of improvement.

·         Assessed with subjective and objective parameters of Dwitiya Patalagata Timira before and after the treatment with appropriate statistical method.

8. REFERENCE:

1) Malhotra S, Vashist P, Kalaivani M, Rath RS, Gupta N, Gupta SK, Prasad M, Sathiyamoorthy R. Prevalence of presbyopia, spectacles coverage and barriers for unmet need among adult population of rural Jhajjar, Haryana. J Family Med Prim Care. 2022 Jan;11(1):287-293. doi: 10.4103/jfmpc.jfmpc_1148_21. Epub 2022 Jan 31. PMID: 35309602; PMCID: PMC8930150.

2) K. Niteshwar & Dr. R. Vidyanath, Sahasrayogam (3/5) Text with English Translation ,2nd edition, Chowkamba Sanskrit Series Office, 2008. p.68

3) Chikitsa Manjari, Dr. Sreeman Namboothiri, Edition 9, January 2010 Published By Vidyarambham Publishers, ISBN 81-85315-41-8, Page no. 466


 
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