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CTRI Number  CTRI/2022/10/046381 [Registered on: 11/10/2022] Trial Registered Prospectively
Last Modified On: 10/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical Study To Evaluate The Efficacy Of Timirhara Lauha Internally And Dhatyadi Rasakriya Anjana In The Management Of Prathama Patalagata Timira w.s.r Simple Myopia 
Scientific Title of Study   Clinical Study To Evaluate The Efficacy Of Timirahara Lauha And Dhatryadi Rasakriya Anjana In Prathama Patalagata Timira w.s.r 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 Nalini Yadav 
Designation  PG SCHOLAR 
Affiliation  Dr BRKR Govt Ayurvedic College Hyderabad 
Address  Dept of Shalakya Dr BRKR Govt Ayurveda College, Erragadda,Hyderabad

Hyderabad
TELANGANA
500038
India 
Phone  6265269364  
Fax    
Email  naliniyadav60@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  K Anasuya 
Designation  Professor and Guide 
Affiliation  Dr BRKR Govt Ayurvedic College Hyderabad  
Address  Dept of Shalakya Dr BRKR Govt Ayurveda College, Erragadda,Hyderabad

Hyderabad
TELANGANA
500038
India 
Phone  9985266955  
Fax    
Email  kanasuya9191@gmail.com  
 
Details of Contact Person
Public Query  
Name  K Anasuya 
Designation  Professor and Guide 
Affiliation  Dr BRKR Govt Ayurvedic College Hyderabad  
Address  Dept of Shalakya Dr BRKR Govt Ayurveda College, Erragadda,Hyderabad

Hyderabad
TELANGANA
500038
India 
Phone  9985266955  
Fax    
Email  kanasuya9191@gmail.com  
 
Source of Monetary or Material Support  
Govt Ayurvedic Hospital ,A G Colony road,Opposite ESI hospital, Erragadda,Hyderabad.,Telangana Pin - 500038 
 
Primary Sponsor  
Name  Dr Nalini Yadav 
Address  Dr BRKR Govt Ayurveda College, Erragadda,Hyderabad 
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 Nalini Yadav  Govt. Ayurvedic Hospital, erragadda  Room no 11 Department Of Shalakya Govt Ayurvedic Hospital,Erragadda
Hyderabad
TELANGANA 		 6265269364

naliniyadav60@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: Pratham Patalagata Timira, (2) ICD-10 Condition:H521||Myopia. Ayurveda Condition: TIMIRAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Timirhara Lauha, Reference: Bheshajya ratnawali 64/220, Route: Oral, Dosage Form: Lauha-Mandura, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 40 Days, anupAna/sahapAna: Yes(details: -ghrita 2gm and madhu 1gm), Additional Information: -
2Intervention ArmProcedure-a~jjanam, अंजनम् (Procedure Reference: Sushruta Uttara Tantra 18/51, Procedure details: Anjana is a procedure of applying medicinal paste or powders to the inner side of lower eyelid either by fingertips or with an applicator.)
(1) Medicine Name: Dhatryadi Rasakriya Anjana, Reference: Chakradutta 59/149, Route: Ocular, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 60(mg), Frequency: od, Duration: 21 Days
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1) Patients presenting with classical features of
Prathama Patalagata Timira.
2) Patient Presenting with classical feature of
Simple Myopia.
3) Patient having refractive error between -0.5D to
-6D. 
 
ExclusionCriteria 
Details  1) Patient having refractive error more than -6D.
2) Patient having other ocular pathology like -
Cataract, Corneal opacity ,Corneal ulcer.
3) Patient having systematic disorders like Cardio
vascular disorder, Diabetes and Hypertension.
4) Contraindicated for Anjana. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in visual acuity of the patient.
 		 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in quality of life.  6 week 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/11/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [naliniyadav60@gmail.com].

  6. For how long will this data be available start date provided 21-07-2023 and end date provided 21-11-2023?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Myopia is a major public health problem pertaining to eye that entails substantial social, personal ,educational, and economic impacts .Though the modern counterpart has made tremendous progress in the field of ophthalmology but no satisfactory and universally accepted treatment of Myopia is available .Myopia progression is irreversible and there is no cure. Methods of the correction of Myopia are not without complications, including corneal infections due to contact lens wear and corneal scarring and persistent corneal haze from refractive surgery. in Ayurveda texts Timira is said to be " Aushadh sadhya Vyadhi" i.e, medically treatable disease. Various treatment modalities like Snehapana, Sanshodhana, Nasya, Tarpana, Anjana are described in detail. Daily health regimen for healthy eye like Trataka, Padabhayanga, Pranayama, eye exercises are also implemented along with Nidana parivarjana. In the light of above mentioned scenario " DHATRYADI RASAKRIYA ANJANA’ and "TIMIRHAR LAUHA" , has been selected for evaluation of its clinical efficacy in Prathama Patalgata Timira.  
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