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CTRI Number  CTRI/2020/10/028381 [Registered on: 13/10/2020] Trial Registered Prospectively
Last Modified On: 24/09/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of local Ayurveda therapy along with certain oral drug in the management of Presbyopia  
Scientific Title of Study   A Randomized Clinical study to evaluate the efficacy of Bibhitakadi Ghrita Tarpana and Ayastha Triphala with Ghrita as oral intake in the management of Timira w. s. r. to 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 Sanjeev Sharma 
Designation  Professor and Director 
Affiliation  National institute of Ayurveda 
Address  National institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9418079691  
Fax    
Email  profsanjeevhp@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjeev Sharma 
Designation  Professor and Director 
Affiliation  National institute of Ayurveda 
Address  National institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur


RAJASTHAN
302002
India 
Phone  9418079691  
Fax    
Email  profsanjeevhp@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanjeev Sharma 
Designation  Professor and Director 
Affiliation  National institute of Ayurveda 
Address  National institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur


RAJASTHAN
302002
India 
Phone  9418079691  
Fax    
Email  profsanjeevhp@gmail.com  
 
Source of Monetary or Material Support  
National institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002 
 
Primary Sponsor  
Name  National Institute of Ayurveda Jaipur 
Address  National Institute of Ayurveda, Amer Road, Jaipur 
Type of Sponsor  Research institution and hospital 
 
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 Prabhakar Vardhan  National institute of Ayurveda Hospital  OPD no. 14 Shalakya Tantra Department National institute of Ayurveda Jorawar Singh Gate Amer Road
Jaipur
RAJASTHAN 		 9461065960

shalakya007@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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bibhitakadi ghrita Tarpana  Tarpana Protocol Purva karma: Netra parisheka with 50-60 ml of Triphaladi kwatha in morning for 5 days for Aama pachana and Nasya with Anu taila 6 drops in each nostril in morning for 5 days Pradhana karma: Tarpana with Bibhitakadi Ghrita 20ml per sitting in morning for 5 days The same procedure for each eye will be repeated after a gap of 10 days with 3 consecutive sittings.  
Comparator Agent  Bibhitakadi ghrita Tarpana along with Ayastha Triphala kwatha with goghrita orally  Tarpana protocol: as mentioned in intervention group Oral drug protocol : Ayastha triphala kwatha 20-30ml with goghrita 10 gm oral intake once a day at bedtime for 45 days  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  i) Patients willing to participate in this trial through written informed consent
ii) Patients who are 35 years of age and from either sex
ii) Patients having specific symptoms of prathama and dwitiya patalagata timira.
iii) Early to moderate presbyope determined by screening monocular best-corrected distant visual acuity (VA)
 
 
ExclusionCriteria 
Details  i) Patients with active ocular infection at visit 1 (bacterial, viral or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation (eg, moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis), moderate to severe dry eye in either eye.
ii) Patients with clinically significant abnormal lens findings (eg cataract) including early lens changes and/or any evidence of media opacity in either eye
iii) Patients having intraocular pressure (IOP) that is less than 5 millimeters of mercury (mmHg) or greater than 22 mmHg in either eye documented at visit 1, or have a prior diagnosis of ocular hypertension or glaucoma or currently being treated with any type of topical IOP lowering (glaucoma) medication at visit 1.
iv) Patients who have abnormal findings on dilated fundus exam in either eye on visit 1 or a known history of retinal detachment or clinically significant retinal disease in either eye.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the efficacy of Bibhitakadi Ghrita Tarpana and Aystha Triphala with Ghrita as oral intake in the management of Timira w. s. r. to Presbyopia
 		 45 days
 
 
Secondary Outcome  
Outcome  TimePoints 
Any adverse event reported voluntarily, observed or enquire
 		 45 days 
 
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 1/ Phase 2 
Date of First Enrollment (India)   01/12/2020 
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="5"
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 study will be a Randomized clinical Trial phase 1/ phase 2. 

Purpose- To evaluate and compare the efficacy of Bibhitakadi Ghrita Tarpana and Aystha Triphala with Ghrita as oral intake in the management of Timira  w. s. r. to Presbyopia.

  • Group I: 30 patients of prathama and dwitiya patalagata timira (Presbyopia) will be administered Bibhitakadi ghrita Tarpana  topically. 

  • Group II: 30 patients of prathama and dwitiya patalagata timira (Presbyopia) will be administered Bibhitakadi ghrita Tarpana  topically along with Ayastha Triphala kwatha with goghrita oral intake at bedtime.

 
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