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CTRI Number  CTRI/2025/04/085566 [Registered on: 24/04/2025] Trial Registered Prospectively
Last Modified On: 23/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Biological
Ayurveda
Preventive
Other (Specify) [Therapeutic]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical study to see the effect of Ayurvedic formulation in the treatment of motiyabind (Cataract) 
Scientific Title of Study   A randomized controlled trial on the efficacy of Guduchyadi Anjana and Sodium Chloride Eye Drop in Kaphaj Timira with reference to Lens Opacification in Senile Immature Cataract  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vd Komal Vidyadhar Garad 
Designation  MS Scholar Shalakyatantra (Ayurved) 
Affiliation  MAMS Sumatibhai Shah Ayurved Mahavidyalaya 
Address  OPD no. 09, Department of Shalakyatantra, Sane Guruji ArogyaKendra, Malwadi road, Hadapsar Pune MAHARASHTRA 411028 India

Pune
MAHARASHTRA
411028
India 
Phone  9960470605  
Fax    
Email  komalvidyadhar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Mrs Nilakshi S Pradhan 
Designation  HOD Shalakyatantra 
Affiliation  MAMS Sumatibhai Shah Ayurved Mahavidyalaya 
Address  OPD no. 09, Department of Shalakyatantra, Sane Guruji ArogyaKendra, Malwadi road, Hadapsar Pune MAHARASHTRA 411028 India

Pune
MAHARASHTRA
411028
India 
Phone  9423580963  
Fax    
Email  drnspradhan@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Prof Mrs Nilakshi S Pradhan 
Designation  HOD Shalakyatantra 
Affiliation  MAMS Sumatibhai Shah Ayurved Mahavidyalaya 
Address  OPD no. 09, Department of Shalakyatantra, Sane Guruji ArogyaKendra, Malwadi road, Hadapsar Pune MAHARASHTRA 411028 India

Pune
MAHARASHTRA
411028
India 
Phone  9423580963  
Fax    
Email  drnspradhan@yahoo.com  
 
Source of Monetary or Material Support  
Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune 411028 Maharashtra India 
 
Primary Sponsor  
Name  Sane Guruji Arogya Kendra 
Address  165, Malwadi road, Hadapsar, Pune 411028 Maharashtra, India 
Type of Sponsor  Research institution and hospital 
 
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 
Vd Komal V Garad  Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune411028  OPD no. 09, Department of Shalakyatantra, Sane Guruji ArogyaKendra, Malwadi road, Hadapsar Pune MAHARASHTRA 411028 India
Pune
MAHARASHTRA 		 09960470605

komalvidyadhar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumatibhai Shah Ayurved Mahavidyalaya and Sane Guruji Arogya Kendra   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H259||Unspecified age-related cataract. Ayurveda Condition: TIMIRAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-a~jjanam, अंजनम् (Procedure Reference: Ashtanghridayam Sutrasthan 23/26, Procedure details: 1. Patient will be advised to wash their hands before applying Varti 2. Patient will be instructed to levigate Varti in honey about 4-5 rounds, while looking upward apply it to the margin of lower eyelid. 3.Closed eyes for 2-3 minutes.)
(1) Medicine Name: Guduchyadi Anjana, Reference: Yogratnakar Netraroga adhikar, Route: Ocular, Dosage Form: Varti/ Suppository, Dose: 2(drops), Frequency: bd, Duration: 45 Days
2Comparator Arm (Non Ayurveda)-Sodium chloride Eye dropSodium Chloride Eye Drop will be instilled two times in a day by topical route.
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1 Patient of age group 50 to 70 years
2 Visual acuity of 6/12 or less Without power glass or with power glass
3 Patients showing symptoms of Kaphaja Timira the moon the sun the flame etc appear lusterless and as though covered with thin cloth Sitabha Drusti
4 Irrespective of gender caste and socio-economic status 
 
ExclusionCriteria 
Details  1 Senile mature or hyper mature cataract
2 Visual acuity of less than 6/60
3 Congenital traumatic complicated and metabolic cataract
4 Patients having Retinal disorders
5 Patients with any other systemic disease such as DM HTN 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate efficacy of topical administration of Guduchyadi Anjana in Kaphaja Timira with referance to Senile Immature Cataract which will be assessed on the basis of Visual Acuity and Gradations of Cataract as per WHO  The total duration of treatment for each patient will be 45 days with follow up on 0th, 15th 30th and 45th day with an observational follow up on 60th day. The effect will be assessed before and after treatment on gradation of lens opacity as per WHO grading system. 
 
Secondary Outcome  
Outcome  TimePoints 
decrease in severity, intensity, duration of symptoms  18 Months 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   30/05/2025 
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="15" 
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  
     The term cataract refers to development of any opacity in the lens or its capsule. Cataract may occur, either due to formation of opaque lens fibres or due to degenerative process leading to opacification of the normally formed transparent lens fibres.
Age related cataract also called Senile Cataract is the commonest type of acquired cataract above the age of 50 years. The condition is usually bilateral, but almost always one eye is affected earlier than the other.
     In Ayurveda visual disturbances are described in the context of Timira. According to Acharya Sushruta, Timira is one of the Drishtigata Netra Rogas, if proper care is not taken it leads to Kacha which converts to Linganasha. Timira is an early stage characterized by blurring of vision and Linganasha is the end stage where complete loss of vision occurs.Acharyas have advocated different Anjana application and oral medications in the Timira and Kacha stage.
    Anjana is one of the ocular therapeutics of Ayurveda, which is very helpful in treating various eye disorders, Timira is one among them. Application of Anjana is advisable both in healthy and diseased person.
 
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