| 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 |
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Type of Study
|
Drug Ayurveda Yoga & Naturopathy Preventive |
| Study Design |
Single Arm Study |
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Public Title of Study
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Effect of localised mud therapy on eyes in Digital eye strain |
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Scientific Title of Study
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Efficacy of Mrillepa Pattika (Mud Pack) on Chakshu Swasthya wsr Digital eye strain- An open labelled single arm clinical trial |
| Trial Acronym |
NIL |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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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 |
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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 |
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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 |
|
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Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda Jamnagar |
|
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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 |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| 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 |
|
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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 |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H578||Other specified disorders of eye and adnexa. Ayurveda Condition: NETRAROGAH/AKSHIROGAH, |
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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 |
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Inclusion Criteria
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| 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)
|
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| 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.
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Improvement of the Chakshu Swasthya in Digital Eye Strain.
|
4 weeks |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the Quality of Life. |
4 weeks |
|
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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" |
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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 |
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Estimated Duration of Trial
|
Years="1" Months="10" Days="0" |
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Recruitment Status of Trial (Global)
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Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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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