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CTRI Number  CTRI/2024/03/064252 [Registered on: 15/03/2024] Trial Registered Prospectively
Last Modified On: 10/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Yoga & Naturopathy
Preventive 
Study Design  Single Arm Study 
Public Title of Study   Effect of localised mud therapy on eyes in Digital eye strain 
Scientific Title of Study   Efficacy of Mrillepa Pattika (Mud Pack) on Chakshu Swasthya wsr Digital eye strain- An open labelled single arm clinical trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vd Runa Patel 
Designation  MD Scholar 
Affiliation  Institute of Teaching and Research in Ayurveda Jamnagar 
Address  Department of Swasthavritta Dhanvantari mandir Institute of Teaching and Research in Ayurveda Jamnagar Gujarat India

Jamnagar
GUJARAT
361008
India 
Phone  8018182574  
Fax    
Email  runapatel0001@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Vd Arpan A Bhatt 
Designation  Professor and Head of Department 
Affiliation  Institute of Teaching and Research in Ayurveda Jamnagar 
Address  Room no 5 Department of Swasthavritta Dhanvantari mandir Institute of Teaching and Research in Ayurveda Jamnagar Gujarat

Jamnagar
GUJARAT
361008
India 
Phone  9998968727  
Fax    
Email  vdarpansoniac@itra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Prof Vd Arpan A Bhatt 
Designation  Professor and Head of Department 
Affiliation  Institute of Teaching and Research in Ayurveda Jamnagar 
Address  Room no 5 Department of Swasthavritta Dhanvantari mandir Institute of Teaching and Research in Ayurveda Jamnagar Gujarat

Jamnagar
GUJARAT
361008
India 
Phone  9998968727  
Fax    
Email  vdarpansoniac@itra.edu.in  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda Jamnagar 
 
Primary Sponsor  
Name  Institute of Teaching and Research in Ayurveda Jamnagar 
Address  Opposite Reliance Smart, near B Division,Police station Gurudwara road 
Type of Sponsor  Research institution and hospital 
 
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 Runa Patel  Institute of Teaching and Research in Ayurveda  OPD no 12 Department of Swasthavritta and Yoga UG campus Institute of Teaching and Research in Ayurveda Jamnagar Gujarat 361008
Jamnagar
GUJARAT 
8018182574

runapatel0001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Institute of Teaching and Research in Ayurveda(Institute of National Importance) Jamnagar Gujarat 361008  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H578||Other specified disorders of eye and adnexa. Ayurveda Condition: NETRAROGAH/AKSHIROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-mrillepa pattika(mud therapy) (Procedure Reference: ShriHariprasad Pandeyen,Bhavprakash,Madhyam khanda,Samastnetra roga Adhyaya 63,verse no 169 Chaukhambha Sanskrit sansthan reprint 2000,657, Procedure details: Fine mud powder will be taken and a paste will be made with tap water. Muslin cloth having 12x6 inch length and width will be sterilized by boiling it in water. The paste will be spreaded on the cloth. Mrillepa pattika (mud pack) having thickness of 1/2cm will be placed on both the eyes till cold mud starts feeling hot (approx 10 mins). Then pack will be removed and the area will be washed with lukewarm water. )
(1) Medicine Name: Krishna Mrittika, Reference: Kaviraj Dr.Ambikadatt shastri, Susrut samhitaSutra sthana,Bhumipravibhagiya Adhyaya37,verse no.3,Chaukhamba Sanskrit Sansthan Varanasi,Reprint 2018,180, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 40(g), Frequency: od, Duration: 4 Weeks
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Patients who are willing to participate.
Age: between 18 to 45 years
Sex: Patients of either sex will be selected.
Patients having minimum any 3 sign and symptoms of Digital Eye Strain or having minimum 6 CVS-Q score.
Patients having any 2 positive findings of mentioned tests.Visual acquity test
Slit lamp examination
Schirmer –I test
Fluorescein Tear film break up test (TBUT)
Rose Bengal test(Oxford Scheme of Scoring)
 
 
ExclusionCriteria 
Details  Patient who are not willing to participate.
Age: less than 18 years and more than 45 years
Patients having systemic diseases like uncontrolled DM, RA .
Patients suffering from other eye complaints like cataract, glaucoma, pterygium .
Patients suffering from any infectious skin diseases on and around the eye.
Patients taking any hormonal therapy.
Patients taking any antibiotic, analgesic or any medicine which has ocular response.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement of the Chakshu Swasthya in Digital Eye Strain.
 
4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in the Quality of Life.  4 weeks 
 
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   Phase 3 
Date of First Enrollment (India)   03/06/2024 
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="1"
Months="10"
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  

 EFFICACY OF MRILLEPA PATTIKA (MUD PACK) ON  CHAKSHU SWASTHYA W.S.R TO DIGITAL EYE STRAIN – AN OPEN  LABELLED SINGLE ARM CLINICAL TRIAL

 

Introduction:

Mrittika (Mud) is one element of nature having enormous impact on healthy life and therapeutic effect in various diseases. The chemical composition of Mrittika (Mud) varies from place to place and the process of soil formation can be understood on the basis of its color and Guna. Mrittika(Mud) has high water retaining capacity and its consistency can be changed easily by adding water. Properties of water present in particular type of Mrittika is described in the texts. Acharya Charaka has mentioned that properties of water depend upon the type of soil on which  it falls.

Majority of modern day life style disorders are strain related disorders and psychosomatic in origin .Spending too much time in one posture and continuous exposure to screen of electronic devices could be seriously damaging to human health. For the manifestation of diseases. Acharya Charaka has enumerated three causative factors: Atiyoga, Ayoga and Mithya Yoga of Indriyartha, Karma (Kayika, Vachika, Manashika) and Kala.   Here excessive or improper use of any self-illuminated devices like computer and mobile phones will lead to Atiyoga or/and Mithya Yoga of Chakshu Indriya which results in ocular and extra ocular complaints. 

Significance

In this high technological era, the computer, laptop, mobile phones have become essential parts of life and due to this high screen time has increased. According to the American Vision Council, 80% of adults use digital devices for at least 2 hours daily and more than 65% of adults use atleast 2 devices simultaneously.Globally near 60 million people are suffering from Digital Eye Strain and approximately a million new cases occur every year.In India, the computer using population is more than 40 million and 80% of them have discomfort due to Computer Vision Syndrome. The percentage of persons suffering from eye discomfort among video display terminals(VDT) workers is quite alarming in some states, its nearly 50%.The yearly costs may approach $2 billion for diagnosing and treating these issues.Whereas with regards to Digital eye strain the treatments which have been sorted for are like Anjana,Ashchyotana, Tarpana, Seka,Trataka, Cold compress.

As prevalence of digital eye strain is increasing day by day it is the need of time to find out appropriate measure for the same. Mud therapy or Mrittika chikitsa is appropriate and effective measure which is easily available and cost effective as well. Mrittika in the form of Mrillepa Pattika (mud pack) on the eye is a simple yet efficient and treatment modality as compared to other procedures.

 Aim and Objectives:

To evaluate the efficacy of Mrillepa Pattika on eye in improving  Chakshu Swasthya w.s.r Digital  Eye Strain and also to assess the quality of life.

Materials and Methods:

30 patients having symptoms of Digital eye strain will be enrolled.Fine mud powder will be taken and a paste will be made with tap water. Muslin cloth having 12x6 inch length and width will be sterilized by boiling it in water.The paste will be spreaded  on the cloth. Mrillepa pattika (mud pack) having thickness of 1/2cm will be placed on both the eyes till cold mud starts feeling hot (approx 10 mins).Then pack will be removed and the area will be washed with lukewarm water.After treatment pack will be removed  and a clean medicated cotton swab will be taken .It will be soaked in lukewarm water and eyes will be cleaned in direction from inner canthus to outer canthus 3 times.After that let it dry on its own and then eyes will be washed by lukewarm water.

Results and Discussion:

Data generated during the above study will be present in a systemic manner as shall be analyzed statically. Where the important points of the Conceptual study, Analytical study, Pharmacological study will be discussed.

Follow up:

After completion of therapy, follow up will be done for 4 weeks to assess the status of patient, where patient will be asked to report.

Adverse effects:

This drug have no known unwanted effects. Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance cell of I.T.R.A., Jamnagar.


 
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