CTRI

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CTRI Number

CTRI/2021/08/035591 [Registered on: 11/08/2021] Trial Registered Prospectively

Last Modified On:

30/07/2021

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Single Arm Study

Public Title of Study

Effect of Ushiraadi anjana & Dwitiya Triphaladi ghrita pana in Timira(Presbyopia)

Scientific Title of Study

To study the effect of Ushiraadi anjana & Dwitiya Triphaladi ghrita pana in Timira(Presbyopia)

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Renu Prasad
Designation	Associate Professor
Affiliation	Rishikul Campus, haridwar Uttarakhand Ayurved University
Address	Shusruta Bhawan, PG department of Shalakya Tantra Rishikul Campus,Haridwar Uttarakhand Ayurved University Hardwar UTTARANCHAL 249401 India
Phone	9358826470
Fax
Email	docrenuprasad@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Renu Prasad
Designation	Associate Professor
Affiliation	Rishikul Campus, haridwar Uttarakhand Ayurved University
Address	Shusruta Bhawan, PG department of Shalakya Tantra Rishikul Campus,Haridwar Uttarakhand Ayurved University Hardwar UTTARANCHAL 249401 India
Phone	9358826470
Fax
Email	docrenuprasad@gmail.com

Details of Contact Person
Public Query

Name	Dr Renu Prasad
Designation	Associate Professor
Affiliation	Rishikul Campus, haridwar Uttarakhand Ayurved University
Address	Shusruta Bhawan, PG department of Shalakya Tantra Rishikul Campus,Haridwar Uttarakhand Ayurved University Hardwar UTTARANCHAL 249401 India
Phone	9358826470
Fax
Email	docrenuprasad@gmail.com

Source of Monetary or Material Support

Rishikul Campus, Haridwar Uttarakhand Ayurved university

Primary Sponsor

Name	Rishikul campus Haridwar UAU
Address	Uttarakhand Ayurved University Harrawala, Dehradun
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
Dr Merilu Manyu	Rishikul Government P.G Ayurvedic college & Hospital	P.G Department of Shalakya Tantra, Sushruta Bhawan. Rishikul Campus, 249401 (OPD NO.5) Hardwar UTTARANCHAL	7578887498 afrailiang1693@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional ethics committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:H524\|\|Presbyopia. Ayurveda Condition: Dwitiya Patalagata Timira,

Intervention / Comparator Agent

Type	Name	Details
Intervention	1.Ushiraadi Anjana for topical application. 2.Dwitiya Triphaladi ghrita pana for oral intake.	1.Topical application of Ushiraadi Anjana in conjunctival fornices from inner canthus to outer canthus with the dose of 90 mg twice a day. 2.Oral administration of Dwitiya Triphaladi ghrita in the dose of 12 ml twice a day before meal with luke warm water.
Comparator Agent	not applicable	not applicable

Inclusion Criteria

Age From	35.00 Year(s)
Age To	55.00 Year(s)
Gender	Both
Details	1.Patients presenting with clinical features of Dwitiya patalagata timira(Presbyopia) 2. Patients between age group of 35-55 years 3. Patients having near visual acuity < N6 or N6 with strain 4. Patient having distant vision 6/6 or best corrected distant vision

ExclusionCriteria

Details

1.Tritiya & Chaturtha patalagata Timira.
2.Patient with infective anterior segment disease & any other ocular pathologies like cataract, glaucoma & retinal pathologies.
3.Patients who have underwent any of the ocular surgeries
4.patients suffering from any of the systemic disorders (Hypertension, diabetes,dislipidemia)

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Near vision improvement	at 1st day, 25th day, 45th day

Secondary Outcome

Outcome	TimePoints
Relief in other signs & symptoms of Presbyopia	1st day , 25th day , 45th day

Target Sample Size

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"

Phase of Trial

N/A

Date of First Enrollment (India)

16/08/2021

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

Estimated Duration of Trial

Years="0"
Months="10"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

Nil

Individual Participant Data (IPD) Sharing Statement

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

Response - NO

Brief Summary

The Clinical study will be conducted with aim to provide a better treatment approach to patients of Dwitiya Patalagata Timira ( Presbyopia). In this clinical study Ushiraadi Anjana & Dwitiya Triphaladi Ghrita pana will be administered to the patients selected randomly for clinical trial. Total 40 patients fulfilling the inclusion & exclusion criteria will be registered in a single group for this study from OPD/IPD of P.G department of Shalakya Tantra, Rishikul campus, Haridwar. Uttarakhand Ayurved University.A detailed proforma will be prepared on the basis of Ayurvedic texts & allied science.The scoring of different clinical features will be done on the basis of different assessment criterian. After completion of 45 days trial, 2 follow ups will be done at intervals of 1 month.The different tables of scores obtained before & after treatment will be prepared for the comparison & statistical analysis will be done by applying suitable tests.The inference will be made on the basis of statistically analysed data.