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CTRI Number  CTRI/2024/04/066278 [Registered on: 25/04/2024] Trial Registered Prospectively
Last Modified On: 24/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect Of Guduchyadi Rasakriya Anjana In Short-Sightedness 
Scientific Title of Study   A Randomized Controlled Clinical Study On Add-On Effect Of Guduchyadi Rasakriya Anjana In 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 Yash B Jain 
Designation  PG Scholar 
Affiliation  Bharati Vidyapeeth Deemed to be University College of Ayurved 
Address  Bharati Vidyapeeth Deemed to be University College of Ayurved Department of Shalakyatantra Dhankawadi Campus Katraj Pune

Pune
MAHARASHTRA
411043
India 
Phone  8407945741  
Fax    
Email  yash.jain-ayurved@bvp.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Santosh Mulik 
Designation  Professor 
Affiliation  Bharati Vidyapeeth Deemed to be University College of Ayurved 
Address  Bharati Vidyapeeth Deemed to be University College of Ayurved Department of Shalakyatantra Dhankawadi Campus Katraj Pune

Pune
MAHARASHTRA
411043
India 
Phone  9823491389  
Fax    
Email  mulik.santosh@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query  
Name  Dr Santosh Mulik 
Designation  Professor 
Affiliation  Bharati Vidyapeeth Deemed to be University College of Ayurved 
Address  Bharati Vidyapeeth Deemed to be University College of Ayurved Department of Shalakyatantra Dhankawadi Campus Katraj Pune

Pune
MAHARASHTRA
411043
India 
Phone  9823491389  
Fax    
Email  mulik.santosh@bharatividyapeeth.edu  
 
Source of Monetary or Material Support  
DEPARTMENT OF SHALAKYATANTRA, College of Ayurved, Bharati Vidyapeeth (Deemed to be) University, Katraj Dhankawadi Campus, Pune 
 
Primary Sponsor  
Name  Dr Yash B Jain 
Address  DEPARTMENT OF SHALAKYATANTRA, College of Ayurved, Bharati Vidyapeeth (Deemed to be) University, Katraj Dhankawadi Campus, Pune 
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 
DrYash B Jain  Bharati Ayurved Hospital   Bharati Vidyapeeth Deemed To Be University, College Of Ayurved And Hospital, Department Of Shalakyatantra, OPD No 26, Dhankawadi Campus, Katraj, Pune
Pune
MAHARASHTRA 		 8407945741

yash.jain-ayurved@bvp.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE FOR APPROVAL OF A RESEARCH PROJECT  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: TIMIRAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-rasakriyA, रसक्रिया (Procedure Reference: Sushrut Uttartantra 18/52, Procedure details: Anjana will be applied in the lower palpebral conjunvctiva of both the eyes from inner to outer canthus, once a day)
(1) Medicine Name: Guduchyadi Rasakriya, Reference: Sharangdhar Uttarkhanda 43/98-99, Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 125(mg), Frequency: od, Duration: 45 Days
2Comparator Arm (Non Ayurveda)-SpectaclesRegular Use of spectacles
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.Patients between the age group of 18 to 40 years will be included.
2.Patients will be selected irrespective of gender, socioeconomic status and religion.
3.Patients diagnosed with Simple Myopia and his refractive power will be between -0.5D TO
-6.00D 
 
ExclusionCriteria 
Details  1.Patient suffering from high myopia and pathological myopia
2.Patient suffering from any retinal pathologies, ocular surface pathology
3.Patient having congenital anomalies
4.One eyed patient 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Improvement in visual acuity based on LOGMAR chart.
2. Reduction of refractive error in the trial group. 		 Baseline, 15th, 30th, 45th day 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in the symptoms of headache, eye strain and blurring of vision in the trial
group. 		 Baseline, 15th, 30th, 45th day 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 1 
Date of First Enrollment (India)   05/05/2024 
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="0"
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  
Myopia, commonly referred to as short sightedness, 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. Myopia is the most common human eye disorder with its increasing prevalence and earlier age
of onset in recent birth cohorts. Procedures like Tarpana are not cost
effective for all and also it cannot be self-administered. Also, no one has ever studied the
Guduchyadi Rasakriya Anjana as a treatment modality in Simple Myopia. Here,Guduchi is a
Rasayana and Tridosha Shamak while Madhu and Saindhava both have Chakshushya
properties.  Also, Anjana being one of the Kriyakalpas, is mentioned in Dincharya for ocular
health.T
 
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