| CTRI Number |
CTRI/2021/08/035457 [Registered on: 05/08/2021] Trial Registered Prospectively |
| Last Modified On: |
23/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Drug
Ayurveda
Screening |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
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To see the comparative effect of two medicine Jeevantyadi Ghrita and Satvaryadi Churn in Presbyopia |
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Scientific Title of Study
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Evaluation Of Jeevantyadi Ghrita Tarpana And Satvaryadi Churna Orally In Dwitiya Patalgata Timira(Presbyopia) |
| Trial Acronym |
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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)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
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| Name |
Dr Dayashankar singh |
| Designation |
Associated professor |
| Affiliation |
Patanjali bhartiya ayurvigyan evam anusandhan sansthan haridwar |
| Address |
Opd no1 Department of Shalakya Tantra patanjali ayurveda college haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8194028515 |
| Fax |
|
| Email |
dayaayush@gmail.com |
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Details of Contact Person
Public Query
|
| Name |
Dr Dayashankar singh |
| Designation |
Associated professor |
| Affiliation |
Patanjali bhartiya ayurvigyan evam anusandhan sansthan haridwar |
| Address |
Opd no1 Department of Shalakya Tantra patanjali ayurveda college haridwar
Opd no1 Department of Shalakya Tantra patanjali ayurveda college haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8194028515 |
| Fax |
|
| Email |
dayaayush@gmail.com |
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Source of Monetary or Material Support
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| Patanajli ayurveda college |
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Primary Sponsor
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| Name |
Patanjali ayurveda college |
| Address |
Patanjali bhartiya ayurvigyan evam anusandhan sansthan haridwar |
| 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 |
| Ekta goswami |
patanjali ayurveda college haridwar |
Opd no 1 dept of shaakha tantra
Hardwar
UTTARANCHAL |
9773877013
somig1990@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Patanjali Ayurvedic college |
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:H524||Presbyopia. Ayurveda Condition: Dwitiya Patalgata Timira (Presbyopia) , |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
In group A effect jeevantyadi Ghrita as Tarpana for 30 days |
In group B effect of Satvaryadi churna orally for 30 . |
| Comparator Agent |
Not applicable |
Not applicable |
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Inclusion Criteria
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| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1-Patient presenting with classical sign and symptoms of dwitiya Patalgata Timira (presbyopia),2- patients who are fit for Tarpana karma, 3- presbyopic patients if associated with other reflective error e.g.<+1.00Dsph/cyl and <-1.00Dsph/cyl will also be included. |
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| ExclusionCriteria |
| Details |
1-Patients below 35year and above 60 year of age.
2-Patients suffering with serious systemic/metabolic disorder like:Tuberculosis, Diabetes, hypertension etc
3-Patients having complaints of acute/chronic infection of lid, conjunctiva, uveitis,, glaucoma, cataract, corneal opacity, or any other retinal degenerative conditions. |
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Method of Generating Random Sequence
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Random Number Table |
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Method of Concealment
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An Open list of random numbers |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
Subjective parameters-
1-Blurring of near vision
2-Eye strain
3-Headache
Objective parameters
1-Near visual acuity(ETDRS chart/Log MAR chart)
2-Near point assessment by RAF Ruler(Royal Air Force)
3-Distance visual acuity (ETDRS chart/Log MAR chart)
4-Refraction test-Auto refraction,manual refraction. |
Before intervention of Jeevantyadi Ghrita tarpan and Satvaryadi churna in orally |
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Secondary Outcome
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| Outcome |
TimePoints |
Subjective parameters-
1-Blurring of near vision
2-Eye strain
3-Headache
Objective parameters
1-Near visual acuity(ETDRS chart/Log MAR chart)
2-Near point assessment by RAF Ruler(Royal Air Force)
3-Distance visual acuity (ETDRS chart/Log MAR chart)
4-Refraction test-Auto refraction,manual refraction. |
After intervention of Tarpana with jeevantyadi Ghrita and Satvaryadi churna in dwitiya Patalgata Timira (presbyopia). |
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Target Sample Size
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Total Sample Size="40"
Sample Size from India="40"
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
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Phase 2 |
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Date of First Enrollment (India)
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13/08/2021 |
| 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
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Years="1"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
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Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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Not applicable |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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In this trial we are selecting the patients of dwitiya Patalgata Timira(Presbyopia) in which we will do the intervention in two group (20 patients in each group) in one group we will intervene with ayurvedic therapy of Tarpana with jeevantyadi Ghrita and second group Satvaryadi churna orally for 30 days. Assessment should be done on the basis of investigation done during pre-treatment and post treatment and discussed earlier |