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CTRI Number  CTRI/2023/07/054873 [Registered on: 06/07/2023] Trial Registered Prospectively
Last Modified On: 05/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role Of Pratimarsha Nasya with Aschyotana And Marsha Nasya With Tarpana In Treatment of Pratham Patalgata Timira (Simple Myopia) 
Scientific Title of Study   To Evaluate The Effect Of Pratimarsha Nasya With Aschyotana In Comparison To Marsha Nasya With Tarpana In Pratham Patalgata Timira (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  Parul Rawat 
Designation  Pg scholar 
Affiliation  Uttarakhand Ayurveda University, Gurukul Campus Haridwar 
Address  OPD 8 department of shalakya tantra, Uttarakhand Ayurveda University, Sukanya hostel Gurukul campus Haridwar

Hardwar
UTTARANCHAL
249404
India 
Phone  8958035495  
Fax    
Email  rawat.parul23@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aditi 
Designation  Assistant Professor 
Affiliation  Uttarakhand Ayurveda University, Gurukul Campus Haridwar 
Address  OPD 8 Department of Shalakya Tantra, Uttarakhand Ayurveda University, Gurukul Campus Haridwar

Hardwar
UTTARANCHAL
249404
India 
Phone  9719353123  
Fax    
Email  docaditi24@gmail.com  
 
Details of Contact Person
Public Query  
Name  Parul Rawat 
Designation  Pg scholar 
Affiliation  Uttarakhand Ayurveda University, Gurukul Campus Haridwar 
Address  OPD 8 department of shalakya tantra, Uttarakhand Ayurveda University, Sukanya hostel Gurukul campus Haridwar

Hardwar
UTTARANCHAL
249404
India 
Phone  8958035495  
Fax    
Email  rawat.parul23@gmail.com  
 
Source of Monetary or Material Support  
Gurukul campus, Uttarakhand Ayurveda University, Haridwar 
 
Primary Sponsor  
Name  Gurukul Campus Haridwar 
Address  Gurukul Campus 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 
Parul Rawat  Uttarakhand Ayurveda University, Gurukul Campus Haridwar   OPD no. 8 department of Shalakya Tantra, Uttarakhand Ayurveda University, Gurukul Campus Haridwar
Hardwar
UTTARANCHAL 		 8958035495

rawat.parul23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IACUttarakhand Ayurveda University, Gurukul Campus  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 ArmProcedure-pratimarSaH, प्रतिमर्श (Procedure Reference: Astanga Hridya Uttartantra 13/47, Procedure details: After deepana,pachana for three to five days, after which instillation of drug in the form of nasal drops into both nostrils.)
(1) Medicine Name: Bhiringrajadi Taila, Reference: Chakradutta 59/180, Route: Nasal, Dosage Form: Taila, Dose: 2(NA), Frequency: bd, Duration: 35 Days
2Intervention ArmProcedure-AScyotanam, आश्च्योतनम् (Procedure Reference: Astanga Hridya Uttartantra 13/47, Procedure details: After deepana,pachana for three to five days, after which instillation of drug in the form of drops into the eyes from a height of 2 angulas will be done)
(1) Medicine Name: Phaltrikadi Ghrita, Reference: Chakradutta 59/179, Route: Ocular, Dosage Form: Ghrita, Dose: 2(NA), Frequency: bd, Duration: 35 Days
3Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Astanga Hridya Uttartantra 13/47, Procedure details: After deepana,pachana for three to five days, after which snehan(massage) & swedena will be given and then medicine will be poured in both the nostrils alternately.)
(1) Medicine Name: Bhiringrajadi Taila, Reference: Chakradutta 59/180, Route: Nasal, Dosage Form: Taila, Dose: 4(NA), Frequency: od, Duration: 35 Days
4Comparator ArmProcedure-netratarpaNam, नेत्रतर्पणम् (Procedure Reference: Astanga Hridya Uttartantra 13/47, Procedure details: After deepana,pachana for three to five days medicated ghrita will be made to retain in eyes in mould frame of urad dal flour constructed around eye orbit)
(1) Medicine Name: Phaltrikadi Ghrita, Reference: Chakradutta 59/179, Route: Ocular, Dosage Form: Ghrita, Dose: 20(ml), Frequency: od, Duration: 35 Days
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patient presenting with sign and symptoms of Pratham Patalgata Timira and Simple Myopia 
 
ExclusionCriteria 
Details  1. Dwitiya, Tritiya and Chaturtha Patalgata Timira
2. Congenital, Pathological and Functional Myopia
3. Other Refractive Errors (Hypermetropia, Astigmatism)
4. Presbyopia
5. Optical Correction >-3D
6. Patient with uncontrolled Hypertension, Diabetes
7. Unfit for Nasya 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The improvement will be assessed on the basis of;
1. Subjective parameters- Avaykat Darshana(Blurred vision), Eye Strain, Watering of eyes, Headache
2. Objective parameters-
Visual Acuity, Dioptric power 		 The assessment of patient will be done on 1st, 15th & 35th day 
 
Secondary Outcome  
Outcome  TimePoints 
The improvement will be assessed on the basis of;
Eye Strain, Watering of eyes, Headache
 		 The assessment of patient will be done on 1st, 15th & 35th day 
 
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   N/A 
Date of First Enrollment (India)   13/07/2023 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is an open level randomized parallel arm clinical trial to determine the efficacy of pratimarsha nasya with aschyotan and marsha nasya with tarpana in pratham patalgata timira(Simple Myopia) for the age group between 8 to 40 years for 35 days. The study will be conducted at Uttrakhand Ayurveda University, Gurukul Campus, Haridwar on 60 patients. Assessment will be done on the basis of subjective and objective parameters. Study will be conducted at OPD/IPD  level of PG department of Shalakya Tantra. Assessment will be done on 1st, 15th and 35th day of clinical trial and result obtained will be tabulated and statistically analyzed using appropriate tests.  
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