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CTRI Number  CTRI/2021/07/035155 [Registered on: 27/07/2021] Trial Registered Prospectively
Last Modified On: 22/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Saptanna Ghrita and Shringaveradi Taila Nasya in Prathama Patalagata Timira (simple myopia) 
Scientific Title of Study   "Evaluation of Saptanna Ghrita and Shringaveradi Taila Nasya in Prathama Patalagata Timira (simple myopia)" 
Trial Acronym  Simple Myopia 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr R K Bishwal 
Designation  Professor 
Affiliation  Gurukul Campus UAU Haridwar 
Address  OPD NO. 8 PG Department of Shalakya Tantra Gurukul Campus Haridwar UAU
Gurukul Campus UAU Haridwar
Hardwar
UTTARANCHAL
249404
India 
Phone  98370649106  
Fax    
Email  drbishwal72@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr R K Bishwal 
Designation  Professor 
Affiliation  Gurukul Campus UAU Haridwar 
Address  OPD NO. 8 PG Department of Shalakya Tantra Gurukul Campus Haridwar UAU
Gurukul Campus UAU Haridwar
Hardwar
UTTARANCHAL
249404
India 
Phone  98370649106  
Fax    
Email  drbishwal72@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr R K Bishwal 
Designation  Professor 
Affiliation  Gurukul Campus UAU Haridwar 
Address  OPD NO. 8 PG Department of Shalakya Tantra Gurukul Campus Haridwar UAU
Gurukul Campus UAU Haridwar
Hardwar
UTTARANCHAL
249404
India 
Phone  98370649106  
Fax    
Email  drbishwal72@gmail.com  
 
Source of Monetary or Material Support  
Gurukul Campus UAU Haridwar 
 
Primary Sponsor  
Name  Gurukul campus UAU Haridwar 
Address  Gurukul Campus UAU Haridwar 
Type of Sponsor  Government 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 
Sasmita Gumansingh  U.A.U. Gurukul Campus, Haridwar  OPD No. 8, P.G. Department of Shalakya Tantra,Gurukul Campus, Haridwar
Hardwar
UTTARANCHAL 		 9437317615

sasmitagumansingh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Gurukul campus UAU Haridwar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H531||Subjective visual disturbances. Ayurveda Condition: PRATHAMA-PATALAGATADOSHAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Shringaveradi Taila in Simple Myopia  8 Bindu In each nostril.There will be 3 coures of Nasya for 13 days with interval of 3 days. 
Intervention  Shringaveradi Taila Nasya followed by orally Saptanna Ghrita in Simple Myopia  given shringaveradi Taila Nasya 8 bindu in each nostril there will be 3 coures of nasya for 13 days with interval of 3 days followed by 10 ml of Saptanna Ghrita orally twice in a day 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1)The patients presenting with features of Prathama patalagata Timira(Simple Myopia)
2)Vatika Timira
3)Those fit for Nasya
4)Patients having -0.25D to -2.5D of vision.
5)Patients aged between 13 to 35 years. 
 
ExclusionCriteria 
Details  1)Dwitiya,tritiya and chaturtha patalagata timira.
2)Paittik Timira, Shlaismik Timira, Raktaj Timira,Sannipataja Timira.
3)High myopia or progressive myopia.
4)Congenital myopia.
5)Myopia with systemic disease like TB, Hypertension, DM etc.
5)Patients more than -2.5D of vision.
6)Hypermetropia,presbyopia and Astigmatism. 
 
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 
Relief in Subjective parameters like-
1)Avyaktha Darshana(Blurring of Vision)
2)Eye strain
3)Headache
4)Watering eyes 		 1st, 15th, 30th and 45th day. 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment will be done on the basis of Visual acuity and Diopetric power.  At 1st and 45th day. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   05/08/2021 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

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

  6. For how long will this data be available start date provided 05-08-2021 and end date provided 05-08-2026?
    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   This study is a open label, randomised parallel clinical trial to determine the Efficacy of Evaluation of Saptanna Ghrita and Shringaveradi Taila Nasya in Prathma Patalagata Timira in Simple Myopia for age group between 13 to 35 years daily for 45 days.The study will be conducted at Gurukul Campus UAU Haridwar in 40 patients.The assessment will be done on basis of  Subjective and Objective parameters. The study will be conducted at OPD/IPD level of PG Depatment of Shalakya Tantra.The assessment will be done at 1st,15th,30th and 45th day of the clinical trial and the results obtained will be tabulated and statistically analyzed using appropriate tests. 
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