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CTRI Number  CTRI/2024/06/069643 [Registered on: 27/06/2024] Trial Registered Prospectively
Last Modified On: 20/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Role of Triphala ghrita and Drishtivardhak nasya in the management of Pratham patal gata timir or Myopia 
Scientific Title of Study   A Comparative study of combined effect of Triphala ghrita as paan with Drishtivardhak nasya and Akshitarpan with Drishtivardhak nasya in the management of Pratham patal Timira wsr to 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 Pranjali Priya 
Designation  Post Graduate Scholar 
Affiliation  Government Ayurvedic College Kadamkuan Patna 
Address  Department of Shalakya tantra Government Ayuervedic College Kadamkuan Patna

Patna
BIHAR
800003
India 
Phone  7070373649  
Fax    
Email  pranjalipriya93@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prof Ajay Kumar Singh 
Designation  Professor 
Affiliation  Government Ayurvedic College Kadamkuan Patna 
Address  Department of Shalakya Tantra Government Ayurvedic College Kadamkuan Patna

Patna
BIHAR
800003
India 
Phone  9576952168  
Fax    
Email  dr.aksingh969@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prof Ajay Kumar Singh 
Designation  Professor 
Affiliation  Government Ayurvedic College Kadamkuan Patna 
Address  Department of Shalakya Tantra Government Ayurvedic College Kadamkuan Patna

Patna
BIHAR
800003
India 
Phone  9576952168  
Fax    
Email  dr.aksingh969@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurvedic College Kadamkuan Patna 800003 
 
Primary Sponsor  
Name  Ayurvedic College Health Department Government of Bihar 
Address  Government Ayurvedic College and Hospital Kadamkuan Patna 800003 
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 
Dr Prof Ajay Kumar Singh  Government Ayurvedic College And Hospital Patna  Room no 02 Department of Shalakya Tantra
Patna
BIHAR 
9576952168

dr.aksingh969@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Approval of Institutional ethical committee , Government Ayurvedic College Hosptal Patna  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 ArmDrugClassical(1) Medicine Name: Triphala Ghrita, Reference: Ashtang Hridaya Uttar Sthan 13, Route: Oral, Dosage Form: Ghrita, Dose: 20(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 4 Months, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Ashtang Hridaya Uttar Sthan 13, Procedure details: Nasya will be done with 10 drop Drishtivardhak nasya in every morning for 7 days regularly. This procedure will be done for 4 months.)
(1) Medicine Name: Triphala Ghrita, Reference: Ashtang Hridaya Uttar Sthan 13, Route: Ocular, Dosage Form: Ghrita, Dose: 30(g), Frequency: od, Duration: 4 Months
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1.Patient having Simple Myopia up to -1.0D
2.Patient having lakshanas of Pratham Patalgata Doshadushti. 
 
ExclusionCriteria 
Details  1.Patient having myopia more than -1.0D
2.Patient having ocular diseases other than simple myopia
3.Patient having any systemic diseases
4.Patient having post operative myopia 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcomes are -
1. Refractive error
2.Visual acuity
3. Dimness vision
4. Blurred vision
5. Eye strain
6.Headache
7.Watering of eye
8.Redness of eye
 
120 days (4 months) 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcomes are -
1.Refractive error
2.Visual acuity
3. Dimness vision
4. Blurred vision
5. Eye strain
6.Headache
7.Watering of eye
8.Redness of eye
 
3 months 
 
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 3 
Date of First Enrollment (India)   01/07/2024 
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="0"
Months="4"
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 is a major health issue around the world. the World Health Organization estimates that half of the population of the world may be myopic due to excess use of electronic gadgets. In December 2019, a novel coronavirus rapidly spread in China and around the world. The Govt started a nationwide school, college, office closure people do their work in home with many types of gadgets such as laptop, mobile, computer etc. During covid 19 the school-aged children were confined to their home and online courses were offered. By which simple myopia were more developed, a number patient was coming with DOV complain. In the management of myopia modern science recommended proper corrected glasses contact lenses and refractive surgery, they give relief but when people wear glasses and contact lenses, they are feeling uncomfortable improper contact lenes wearing unhygienic conditions orient the corneal pathology that is epithelial erosion, keratitis etc.Refractive surgery is too much costly every person does not effort it.  In our classics there are number of formulation and different administration of drugs for the management of Timir. I have selected the topic Pratham Patal Timir, so I would like to establish the research classical formula of a drugs for the management of Pratham Patal gat timir. We will have to make get rid of glasses, contact lenes, and refractive surgery.   As many patients of simple myopia visit our opd  We felt need to develop a treatment that cause better cure with no or lesser side effects, also we tried to choose the kind of drug that is easily available, safe and cost effective under the guidance of best faculties.  To see the comparative effect rate of Triphla ghrita as paan with drishti vardhak nasya and akshitarpan with drishti vardhak nasya, both group in the management of simple myopia.

 

 
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