| CTRI Number |
CTRI/2026/03/105472 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Ritu Haritaki Rasayana on Age Related Near Vision Problems During Summer Season |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE CHAKSHUSHYA EFFECT OF RITU HARITAKI RASAYANA IN GREESHMA RITU IN PRESBYOPIA |
| 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 Durgawati Devi |
| Designation |
Professor and Hod |
| Affiliation |
National Institute of Ayurveda |
| Address |
205 department of swasthvritta evam yoga national institute of ayurveda near jorawar singh gate amer road jaipur 302002 rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
7073746600 |
| Fax |
|
| Email |
dvd6197@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Durgawati Devi |
| Designation |
Professor and Hod |
| Affiliation |
National Institute of Ayurveda |
| Address |
205 department of swasthvritta evam yoga national institute of ayurveda near jorawar singh gate amer road jaipur 302002 rajasthan
RAJASTHAN
302002
India |
| Phone |
7073746600 |
| Fax |
|
| Email |
dvd6197@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Durgawati Devi |
| Designation |
Professor and Hod |
| Affiliation |
National Institute of Ayurveda |
| Address |
205 department of swasthvritta evam yoga national institute of ayurveda near jorawar singh gate amer road jaipur 302002 rajasthan
RAJASTHAN
302002
India |
| Phone |
7073746600 |
| Fax |
|
| Email |
dvd6197@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda
madhav vilas , near jorawar singh gate, Amer road, Jaipur, Rajasthan India-302002 |
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUTE OF AYURVEDA |
| Address |
Department of Swasthvritta evam Yoga National Institute of Ayurveda near Jorawar singh gate Amer road Jaipur 302002 Rajasthan |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sangeeta varma |
National Institute of Ayurveda |
Dept. of swastavritta,
, national institute of Ayurveda, Jorawar singh gate
Jaipur
RAJASTHAN |
9793281251
sangeeta.dctr@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H278||Other specified disorders of lens. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
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
The study group fulfilling all the following criteria
Clinical features of Presbyopia
Trouble seeing things up close
Needing to hold reading materials farther away to focus on them
Eye strain
Headache
Patients who are willing and able to participate in the study and follow up
|
|
| ExclusionCriteria |
| Details |
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
h/o hypersensitivity to the trial drug.
Contraindication of Haritaki consumption according to Acharya Charaka [3]
AjirniRukshabhuja
Stri-madya karshita
Ardita
Any other condition which the principal investigator thinks may jeopardize the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Amplitude of Accommodation |
Improvement in Amplitude of Accommodation from baseline to 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total Vision of eye IOP Tear film stability in presbyopic population |
: improvement in other clinical features of presbyopia which are vision IOP Tear film stability fromm baseline to 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
07/04/2026 |
| 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="0"
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 Presbyopia?
Hypothesis: H0: There is no Chakshusya effect of Ritu Haritaki Rasayana in Presbyopia. HA: There is Chakshusya effect of Ritu Haritaki Rasayana in Presbyopia. Aim: To Evaluate the Chakshusya effect of Ritu Haritaki Rasayana on Amplitude of Accommodation in Presbyopic Population of Jaipur Objectives: Primary objective - · To evaluate the effect of Ritu Haritaki as a Chakshushya Rasayana on Amplitude of Accommodation in Presbyopic Population in Jaipur Secondary objective - · To assess the effect of Ritu Haritaki on other parameters like vision, IOP, tear film stability in presbyopic population. |