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CTRI Number  CTRI/2018/01/011102 [Registered on: 02/01/2018] Trial Registered Retrospectively
Last Modified On: 27/12/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ayurvedic management of Nearsightedness (myopia) with Nasya karma 
Scientific Title of Study   A clinical study of Timir(Myopia) with Akshyadi taila nasya 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jayesh Ravajibhai Katrodiya 
Designation  MS Scholar 
Affiliation  Govt Akhandanand ayurved college 
Address  Room no 10 Govt akhandanand ayurved college bhadra

Ahmadabad
GUJARAT
380001
India 
Phone  8000521019  
Fax    
Email  Katrodiya.jayesh92@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Krishna J Makadia 
Designation  Reader 
Affiliation  Govt Akhandanand ayurved college 
Address  Room no 10 Govt akhandanand ayurved college bhadra

Ahmadabad
GUJARAT
380001
India 
Phone  9427410171  
Fax    
Email  dr.krishna1111@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jayesh Ravajibhai Katrodiya 
Designation  MS Scholar 
Affiliation  Govt Akhandanand ayurved college 
Address  Room no 10 Govt akhandanand ayurved college bhadra

Ahmadabad
GUJARAT
380001
India 
Phone  8000521019  
Fax    
Email  Katrodiya.jayesh92@gmail.com  
 
Source of Monetary or Material Support  
Govt Akhandanand ayurved college, Bhadra Ahmedabad, Gujarat 
 
Primary Sponsor  
Name  Govt Akhandanand ayurved college 
Address  Govt Akhandanand ayurved college bhadra Ahmedabad 
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 
Jayesh Ravajibhai Katrodiya  Govt Akhandanad ayurved college  Room no 10 Govt Akhandanad ayurved college bhadra
Ahmadabad
GUJARAT 		 8000521019

Katrodiya.jayesh92@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients suffering from Timir(Myopia),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  A clinical study of Timir(Myopia) with Triphala churna  Dose :- 5 gms churna with Ghrita and Madhu (unequal matra). Route of drug administration: Orally Time of administration- at night before meal. Duration :- For 35 days.  
Intervention  A clinical study of Timir(Myopia) with Akshyadi taila nasya  15 patients will be taken in Group A and will be trated with Akshyadi taila nasya in following dose and duration Number of Sitting: - 3 sitting of Nasya. Route of drug administration: Nose Duration: Continuous 7 days in single sitting. Time of administration- Abhuktavat Pratahkala once a day. Dose:- 8 drops in each nostrils. Interval ; between two sittings with the 7 days interval. Total course of Nasya; 35 days.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1. The person with age of 20 years and above 20 years.
2. The person with age of 35 years and below 35 years.
3. A person having classical symptoms of Timir and as well as Myopia.
 
 
ExclusionCriteria 
Details  1 A person with age below 20 years.
2 A person with age above 35 years.
3 Contraindicated for Nasya .
Systemic exclusion
1 Immunological diseases – Autoimmune disease, collagen vascular and immunodeficiency.
2 Pregnancy
3 Diabetes mellitus
4 Hyperlipidaemia
5 Hypertension.
Ocular surface diseases exclusion
1 Dry eye syndrome
2 Lid disorder
3 Conjunctivitis, Keratoconjuctivitis
4 Keratitis
Ophthalmic exclusion
1 Herpes zoster
2 Glaucoma
3 Uveitis
4 Iridocyclitis
5 Any vitreous disease
6 Retinal disease or any retinopathy
7 Any type of ocular injury e.g. blunt trauma, including chemical injury.

Abnormalities of the corneal shape
1 Sharp changes induced by contact lenses
2 Keratoconus
3 Corneal degeneration
4 Keratoglobus
Any previous ophthalmic surgery
1 Radial kerototomy.
2 Penetrating keretoplasty.
3 cataract surgery,
4 LASIK surgery
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Result will be assessed on the basis of relief in the signs and symptoms of Timir(Myopia)  35 days 
 
Secondary Outcome  
Outcome  TimePoints 
Result will be assessed on the basis of relief in the signs and symptoms of Timir(Myopia)  35 days 
 
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)   06/10/2017 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Aim of this study is to know the efficacy of Nasya on Timir(Myopia) in trial group.This study is randomised, patients selection is blinded. Nasya karma will be given as per s.o.p. In control group Triphala churna will be given as per texts.

 
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