CTRI

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CTRI Number

CTRI/2026/02/103078 [Registered on: 05/02/2026] Trial Registered Prospectively

Last Modified On:

23/01/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda
Preventive
Screening

Study Design

Randomized, Parallel Group Trial

Public Title of Study

A winter season study in Jaipur on how Haritaki Rasayana supports eye health in older adults.

Scientific Title of Study

A Randomized Controlled Trial to Evaluate the Chakshushya Effect of Ritu Haritaki Rasayana in Hemant Ritu in Presbyopic Population of Jaipur.

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Dr. Vimleshi Meena
Designation	PG Scholar
Affiliation	National Institute of Ayurveda
Address	Room no.201 Department of Swasthavritta and Yoga National Institute of Ayurveda Jorawar Singh Gate Amer road Jaipur Rajasthan Department of Swasthavritta and Yoga National Institute of Ayurveda Jorawar Singh Gate Amer road Jaipur Rajasthan Jaipur RAJASTHAN 302002 India
Phone	7073639784
Fax
Email	vimleshimeena09@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Durgawati Devi
Designation	Professor and HOD
Affiliation	National Institute of Ayurveda
Address	Room no 205 Department of Swasthavritta and Yoga National Institute of Ayurveda Jorawar Singh Gate Amer road Jaipur Rajasthan Room no 205 Department of Swasthavritta and Yoga National Institute of Ayurveda Jorawar Singh Gate Amer road Jaipur Rajasthan Jaipur RAJASTHAN 302002 India
Phone	7073746600
Fax
Email	dvd6197@gmail.com

Details of Contact Person
Public Query

Name	Vimleshi Meena
Designation	PG Scholar
Affiliation	National Institute of Ayurveda
Address	Room no 201 Department of Swasthavritta and Yoga National Institute of Ayurveda Jorawar Singh Gate Amer road Jaipur Rajasthan Room no 201 Department of Swasthavritta and Yoga National Institute of Ayurveda Jorawar Singh Gate Amer road Jaipur Rajasthan Jaipur RAJASTHAN 302002 India
Phone	7073639784
Fax
Email	vimleshimeena09@gmail.com

Source of Monetary or Material Support

yes

Primary Sponsor

Name	NATIONAL INSTITUTE OF AYURVEDA
Address	Room no 201 Department of Swasthavritta and Yoga National Institute of Ayurveda Jorawar Singh Gate Amer road Jaipur Rajasthan 302002
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 Vimleshi Meena	National Institute of ayurveda	Room no 21 Department of Swasthavritta and Yoga National Institute of Ayurveda Jorawar Singh Gate Amer road Jaipur Rajasthan 302002 Jaipur RAJASTHAN	7073639784 vimleshimeena09@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA	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: NETRAROGAH/AKSHIROGAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm (Non Ayurveda)		-	No intervention	control group
2	Intervention Arm	Drug	Classical		(1) Medicine Name: Ritu Haritaki, Reference: Bhav Prakash Nighantu, Madhyam, Haritakyadi Varga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: sunthi), Additional Information: -

Inclusion Criteria

Age From	35.00 Year(s)
Age To	55.00 Year(s)
Gender	Both
Details	People of Age 35-55 years of either sex or religion Clinical features of presbyopia Difficulty in near vision Asthenopic symptoms Intermittent diplopia for near work

ExclusionCriteria

Details

H/O hypersensitivity to the trial drug.
Patients having Diabetes and Hypertension.
Patients having lenticular or corneal opacity and with any other known ocular pathologies such as optic atrophy, diabetic retinopathy and hypertensive retinopathy.
History of recent surgical ocular intervention
Contraindication of Haritaki consumption according to Acharya Charaka
Ajirni
Rukshabhuja
Stri madya karshita
Ardita
Any other condition which the principal investigator thinks may jeopardize the study.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Change in Amplitude of Accommodation. Duration of measurement: From baseline and after 8 weeks Method of measurement: Push-up, Push-down and Minus Lens Methods for subjective examination of amplitude of accommodation	8 weeks

Secondary Outcome

Outcome	TimePoints
Gross appearance of eye, Colour vision, Contrast, IOP, Distance visual acuity in presbyopia in presbyopic population. Duration of measurement: From baseline and after every two Suryamana Masa Method of measurement: Visual Acuity test, Slit-lamp examination, Tonometry, Schirmer’s Test	8 weeks

Target Sample Size

Total Sample Size="74"
Sample Size from India="74"
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 2

Date of First Enrollment (India)

09/08/2026

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="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

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

Research Question:

Does Ritu Haritaki Rasayana have Chakshusya effect in Hemant Ritu with special reference to prevention of Presbyopia?

Hypothesis

Null Hypothesis [H₀] There is no Chakshusya effect of Ritu Haritaki Rasayana in Hemant Ritu with special refereance to prevention of presbyopia.

Alternative Hypothesis [H_A] There is Chakshusya effect of Ritu Haritaki Rasayana in Hemant Ritu with special reference to prevention of presbyopia.

Aim

Evaluate the Chakshusya effect of Ritu Haritaki Rasayana in Hemant Ritu on Amplitude of Accommodation in Presbyopic Population.

Objectives

Primary objective

To evaluate the effect of Ritu Haritaki as a Chakshushya Rasayan in Hemant Ritu on Amplitude of Accommodation in Presbyopic Population in NIA Jaipur.

Secondary objective

To assess the effect of Ritu Haritaki Rasayana in Hemant Ritu as a Chakshushya with respect to Gross appearance of eye Colour vision, IOP, visual acuity,tear film stability in presbyopic population.