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CTRI Number  CTRI/2025/09/094472 [Registered on: 09/09/2025] Trial Registered Prospectively
Last Modified On: 12/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical Study Comparing the effect of Patoladi Ghrita and Saptamrit Lauha in Dwitiya Patalgata Timir (Presbyopia). 
Scientific Title of Study   Comparative Clinical Evaluation of Patoladi Ghrita and Saptamrit Lauha in Dwitiya Patalgata Timir (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  Devinder 
Designation  PG Scholar  
Affiliation  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan 
Address  OPD 1, Department of Shalakya Tantra, Patanjali ayurved hospital,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase 1, Roorkee road, Haridwar, Uttarakhand, India 249405

Hardwar
UTTARANCHAL
249405
India 
Phone  7009790289  
Fax    
Email  devindersaini2899@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Jyoti Gupta 
Designation  Professor 
Affiliation  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan 
Address  OPD 1, Department of Shalakya Tantra, Patanjali ayurved hospital,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase 1, Roorkee road, Haridwar, Uttarakhand, India 249405

Hardwar
UTTARANCHAL
249405
India 
Phone  9997907340  
Fax    
Email  jyotiguptania@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Jyoti Gupta 
Designation  Professor 
Affiliation  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan 
Address  OPD 1, Department of Shalakya Tantra, Patanjali ayurved hospital,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase 1, Roorkee road, Haridwar, Uttarakhand, India 249405


UTTARANCHAL
249405
India 
Phone  9997907340  
Fax    
Email  jyotiguptania@gmail.com  
 
Source of Monetary or Material Support  
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan 
 
Primary Sponsor  
Name  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan 
Address  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar, Uttarakhand, India 249405 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Devinder   Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan  OPD 1 , Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar, Uttarakhand, India 249405
Hardwar
UTTARANCHAL 		 7009790289

devindersaini2899@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, haridwar  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: TIMIRAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Patoladi Ghrita, Reference: Ashtang Hridayam uttarsthan,13-6, Route: Oral, Dosage Form: Ghrita, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Warm Milk or Warm Water), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Saptamrit Lauha, Reference: Bhaishajya Ratnavali, 64-225, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Madhu or Ghrita), Additional Information: -
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients between the age group of 35 years to 60 years of either sex.
2. Patients presenting with classical signs and symptoms of Dwitiya Patalagata Timir (Presbyopia).
3. Presbyopic patients associated with refractive error of:-
less than -3.00D spherical or cylindrical.
less than +3.00D spherical or cylindrical.
4. Patients willing to undergo trial. 
 
ExclusionCriteria 
Details  1. Patients below 35 year and above 60 years of age.
2. Patients suffering with serious systemic metabolic disorder like; Tuberculosis,
Diabetes, Hypertension etc.
3. Patients having complaints of acute / chronic infections of lid, conjunctiva, uveitis,
glaucoma, cataract, corneal opacity or any other retinal degenerative conditions.
4. Patients associated with general debility, anaemia and malnutrition.
5. Person having excessive close work undertaken in unfavourable surroundings.
6. Patients not willing to undergo trial.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Blurring of near Vision (Drishtibhrishm Vihvlati)
2. Eye strain (Netrayasa)
3. Headache (Shiroabhitapa) 		 0,10 weeks,12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. Near visual acuity (ETDRS Chart/ Log MAR Chart)
2. Near Point Assessment by RAF Ruler (Royal Air Force) 		 0,10 weeks,12 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   20/09/2025 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  RESEARCH ARTICLES, THESIS

  6. For how long will this data be available start date provided 15-09-2026 and end date provided 10-02-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
This study is a Comparative Clinical Evaluation of Patoladi Ghrita and Saptamrit Lauha in Dwitiya Patalgata Timir (Presbyopia) . 
This will be conducted on 60 randomly selected patients from OPD/IPD of Shalakya- Tantra Department of Patanjali Bhartiya Ayurvigyan
Evam Anusandhan Sansthan, Haridwar. Patient will be divided into two groups- 30 patients will be administered with Patoladi Ghrita orally with warm milk or warm water for 60 days and 30 patients will be administered with Saptamrit Lauha orally with madhu and go ghrita for 60 days. First follow up will be after 15 days of treatment and second follow up will be after 15 days of first follow up. Assesment will be done on the basis of subjective and objective parameters as discussed earlier.

 
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