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CTRI Number  CTRI/2022/04/041862 [Registered on: 13/04/2022] Trial Registered Prospectively
Last Modified On: 12/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   “In Simple Myopia effect of haritkyadi eye drops and eye exercises study" 
Scientific Title of Study   An Open Labelled Randomised Controlled Clinical Trial To Evaluate The Adjuvant Effect Of Haritkyadi Eye Drops And Eye Exercises In Prathama Patalgata Timira With Special Refrences To Simple Myopia.’ 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manjiri Keskar 
Designation  Professor 
Affiliation  Parul Institute of Ayurveda 
Address  OPD-108,Parul Ayurveda hospital, shalakya tantra department, Parul institute of Ayurveda,Parul University, At Post-Limda, Tal- Waghodia, VADODARA, Gujarat. 391760

Vadodara
GUJARAT
391760
India 
Phone  9822606358   
Fax    
Email  manjirikeskar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Priyanka Satapathy 
Designation  PG Scholar 
Affiliation  Parul Institute of Ayurveda 
Address  OPD-108,Parul Ayurveda hospital, shalakya tantra department, Parul institute of Ayurveda,Parul University, At Post-Limda, Tal- Waghodia, VADODARA, Gujarat. 391760

Vadodara
GUJARAT
391760
India 
Phone  8328845165  
Fax    
Email  mail2priyankasatapathy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Priyanka Satapathy 
Designation  PG Scholar 
Affiliation  Parul Institute of Ayurveda 
Address  OPD-108,Parul Ayurveda hospital, shalakya tantra department, Parul institute of Ayurveda,Parul University, At Post-Limda, Tal- Waghodia, VADODARA, Gujarat. 391760

Vadodara
GUJARAT
391760
India 
Phone  8328845165  
Fax    
Email  mail2priyankasatapathy@gmail.com  
 
Source of Monetary or Material Support  
Parul Ayurveda hospital, parul university, at P. O limda, Tal- waghodiya, vadodara- 391760 
 
Primary Sponsor  
Name  Dean Parul institute of Ayurveda  
Address  Parul Ayurveda hospital, Parul University, At P.O-Limda, Tal- Waghodia, VADODARA-391760 
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 
Priyanka SATHPATHY  Parul Institute of Ayurveda  OPD-108, parul Ayurveda hospital, shalakya tantra department, parul university, aat P. Ke limda, Tal- waghodiya, vadodara, 391760
Vadodara
GUJARAT 
8328845165

mail2priyankasatapathy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee  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
1Intervention ArmDrugClassical(1) Medicine Name: Haritakyadi eye drop, Reference: Vangasen36/326, Route: Topical, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 0.70(ml), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 14 Days, Reference: , Route: , Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(3) Medicine Name: 14 Days, Reference: , Route: , Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
2Comparator ArmProcedure-Eye exercises (Procedure Reference: 10. Bates WH. “Perfect eye sight without glasses” 1st Edition 1919. Available from www.eyesightimprovenaturally.com. , Procedure details: Eye wash, Prayer, Deep Breathing, Palming, Shifting the Near and Far Focus, Clock rotation 1. Eye wash-Before commencement of Eye exercise. 2. Prayer- 3. Deep Breathing-5 times 4. Shifting the Near and far focus-10 times 5. Clock and anti clock wise rotation-10 times 6. Palming-10 times sop of eye exercise will be given to all the subjects enrolled and will be demonstrated on 1st days under the supervision of PG scholar and guide. )
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1. Patients presenting with classical features of prathama patalagata timira.
2. Presenting presenting with asthenopic symptoms.
3. With correction <-3Ds
4. Those who are fit for Anjana.
Those who give assent or consent, as per requirement.  
 
ExclusionCriteria 
Details  1.Dwitiya, Trutiya and Chaturtha Patalagata Timira
2.With correction > -3 Ds
3.Patients with ocular manifestations due to serious systemic illness.
4. Patient underwent any of the ophthalmic surgeries.
• Those contraindicated for Anjana.
• Patient with astigmatism will be excluded.
• Known cases of Hypertension, Diabetes etc… 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Preparation of Haritakyadi eye drops which is reduced symptoms like :Blurring of vision
,
Eye strain, Headache ,Watering of eyes  
3 month and 12 week 
 
Secondary Outcome  
Outcome  TimePoints 
Intervention of Haritakyadi eye drop and eye exercise  10 month 
Intervention of eye exercises which is reduced symptoms like : blurring of vision, eye strain, Headache, watering from eyes.  10 month 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
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 2 
Date of First Enrollment (India)   01/05/2022 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   • In Ayurveda, Timira is described as one among the Patalagata Vikruti Lakshana.Netra is given the prime importance among all the Indriyas.
• “द्रुष्टिश्चनिाष्टिष्टिधंजगच्चतमोमयंजायतएकरुपम्"[अ. ह्. सु२४/२३]
• Acharya Vagbhatta, quoted in Ashtanga Hrudaya sincere efforts should be made by
every individual to preserve hisher vision till the last breath of life, because, for an
individual who is blind, day and night are the same and this beautiful world is of no
use to him even if he possesses a lot of wealth.
• So, if vision is lost merely everything is lost. All our daily activities depend on the
quality of our vision. The loss of vision is nothing but the loss of life.
• As described in the ayurvedic literature, Sushruta Samhita, our eyes consist of six
Patalas; 2 Vartama Patalas and 4 Akshigolaka Patalas. The outer one of the four
Akshigolaka patalas i.e. the first Patala is associated with Rasa and Rakta dhatu. It is
supported by Tejas and Jala.
2
• Prathama Patalagata Timira is comparable to the most common refractive error i.e.
Simple Myopia. It manifests as blurring of distant vision. Clinical features related to
visual disturbance are seen only in Drishtigata Netra rogas, and hence all the errors
of refraction can be co-related with Timira-Kaach-Lingnasha..
• Myopia or short-sightedness is a type of refractive error in which parallel rays of light
coming from infinity are focused in front on the retina when accommodation is at
rest.3
• According to the World Health Organisation (WHO)-prevalence of myopia in India is
found to be 6.9%. in fact, vision 2020 which is foremost large scale program.4
• Overall reported prevalence is 20-40% of population.5
• There are various therapeutic procedures known as kriya-kalpa mentioned in our
classical literature for its prevention and cure.
• Anjana is one such simple, non-invasive procedure which can be easily done on the
patients.
• Eye exercises are relaxing techniques which are easy to perform and play an
important role in strengthening and toning eye muscles. It also helps in restoration and
improving eyesight
 
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