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CTRI Number  CTRI/2025/03/081766 [Registered on: 06/03/2025] Trial Registered Prospectively
Last Modified On: 04/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study on the effectiveness of Dhatryadi malahar with and without Netra balya vati for treating Presbyopia 
Scientific Title of Study   A comparative clinical study to asses the efficacy of Netra balya vati and Dhatryadi rasakriya malhara along with Netra balya vati in the management of Dwitiya patalagat timira w.s.r. to 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 Geeta Rathi 
Designation  BAMS MS(Scholar) Shalakyatantra 
Affiliation  D.Y. Patil School of Ayurveda, Navi Mumbai 
Address  D.Y. Patil School of Ayurveda,first floor, OPD No.-04, Department of Shalakyatantra ,Nerul, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  8806220777  
Fax    
Email  komalrathi1205@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kavita Thorat 
Designation  Associate Professor, Shalakyatantra deptartment 
Affiliation  D.Y. Patil School of Ayurveda,Nerul, Navi Mumbai 
Address  D.Y. Patil School of Ayurveda,first floor, OPD No.-04, Deptartment of Shalakyatantra,Nerul, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9167219691  
Fax    
Email  kavita.thorat@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  Dr Kavita Thorat 
Designation  Associate Professor, Shalakyatantra Department  
Affiliation  D.Y. Patil School of Ayurveda,Nerul, Navi Mumbai 
Address  D.Y. Patil School of Ayurveda,first floor, OPD No.-04, Department of Shalakyatantra,Nerul, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9167219691  
Fax    
Email  kavita.thorat@dypatil.edu  
 
Source of Monetary or Material Support  
D Y Patil,School of Ayurveda, Sector 07, Nerul, Navi Mumbai,India.Pin code-400706 
 
Primary Sponsor  
Name  Dr Geeta Rathi 
Address  D.Y. Patil School of Ayurveda,Sector 07,Nerul,Navi Mumbai,India.Pin code-400706 
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 
Dr Geeta Rathi  D Y Patil, School of Ayurveda  D.Y. Patil School of Ayurveda,First floor, OPD No.-04, Department of Shalakya tantra,Nerul, Navi Mumbai.
Thane
MAHARASHTRA 		 8806220777

komalrathi1205@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H524||Presbyopia. Ayurveda Condition: TIMIRAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Dhatryadi malahar, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(drops), Frequency: hs, Bhaishajya Kal: Antarabhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Netra balya vati, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: warm water), Additional Information: -
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1)Patients willing to participant in this trail through written informed consent.
2)Patient who are 35 years to 45 years of age and from any sex.
3)Patients having specific symptoms of Dwitiya patalagata timira. 
 
ExclusionCriteria 
Details  1)A person with age below 35 years and above 45 years.
2)Presbyopia associated with systemic disorders and ocular pathology.
3)Persons with myopia and hypermetropia.
4)Persons who are not willing to give their written consent. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Blurred vision, difficulty in near vision, eye strain   3 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Eye strain, headache, watery discharge  3 Months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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/ Phase 3 
Date of First Enrollment (India)   03/04/2025 
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  
Title 

A comparative clinical study to asses the efficacy of Netra balya vati and Dhatryadi rasakriya malhara along with Netra balya vati in the management of Dwitiya patalagat timira w.s.r. to Presbyopia

In Presbyopia patient becomes spectacle dependent for near reading after 40 years of age.The alternative surgical treatment is costly and not yet proven. Thus, an ayurvedic treatment for Presbyopia needs to be explored. So we tried to escalate this problem by using rich knowledge available in ayurvedic text. In this regard  Netra balya vati and Dhatryadi rasakriya malhara is taken for the management of Dwitiya patalagata timira which is Presbyopia.
 
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