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CTRI Number  CTRI/2022/02/040279 [Registered on: 14/02/2022] Trial Registered Prospectively
Last Modified On: 09/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy of Shunthyadi Aschyotana (Eye Drop) and Mahatriphaladi Ghrita Pana (Orally) in the management of Dry Eye (Due to excessive use of Visual Display Terminal (VDT) gadgets) 
Scientific Title of Study   Efficacy of Shunthyadi Aschyotana (Eye Drop) with and without Mahatriphaladi Ghrita Pana (Orally) in the management of Dry Eye (Due to excessive use of Visual Display Terminal (VDT) gadgets)- An Open Labelled Randomized Comparative Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Meghna Motwani 
Designation  MS Scholar 
Affiliation  Institute of Teaching and Research in Ayurveda 
Address  4th floor Department of Shalakyatantra Institute of Teaching and Research in Ayurveda Opposite Reliance Mart near B division city police station Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9712321618  
Fax    
Email  meghnamotwani22@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepak Pawar 
Designation  Assistant Professor 
Affiliation  Institute of Teaching and Research in Ayurveda 
Address  4th floor Department of Shalakyatantra Institute of Teaching and Research in Ayurveda Opposite Reliance Mart near B division city police station Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  7737379173  
Fax    
Email  drdeep29@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Deepak Pawar 
Designation  Assistant Professor 
Affiliation  Institute of Teaching and Research in Ayurveda 
Address  4th floor Department of Shalakyatantra Institute of Teaching and Research in Ayurveda Opposite Reliance Mart near B division city police station Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  7737379173  
Fax    
Email  drdeep29@gmail.com  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda 
 
Primary Sponsor  
Name  Institute of Teaching and Research in Ayurveda 
Address  Institute of Teaching and Research in Ayurveda Opposite Reliance Mart Near B division Police station Jamnagar 
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 
Meghna Motwani  Institute of Teaching and Research in Ayurveda  4th floor shalakyatantra department Institute of Teaching and Research in Ayurveda Opposite Reliance Mart Near B division police station Jamnagar
Jamnagar
GUJARAT 		 9712321618

meghnamotwani22@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:H049||Disorder of lacrimal system, unspecified. Ayurveda Condition: SUSHKAKSHIPAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-AScyotanam, आश्च्योतनम् (Procedure Reference: A.H. SU. 23/2-3, Procedure details: •Shunthyadi Aschyotana (Eye Drop) is an Anubhuta Yoga. It will be prepared according to Ghrita Paka method in which Shunthi and Saindhava Lavana made into Kalka form by adding adequate quantity of water. •Ghrita Manda will be taken in a stainless-steel vessel and heated mildly to remove any moisture. Then Kalka will be added. Then it will thoroughly be stirred while adding water. The ratio of Kalka: Sneha: Drava Dravya is 1:4:16. •Pattern of heating: Throughout the procedure the temperat)
(1) Medicine Name: Shunthyadi Aschyotana, Reference: Anubhuta, Route: Ocular, Dosage Form: Ghrita, Dose: 1(drops), Frequency: qid, Duration: 1 Months
2Comparator ArmDrugClassical(1) Medicine Name: Mahatriphaladi Ghrita, Reference: Chakradatta, Netraroga Chikitsa Prakarana – 174-181, Route: Oral, Dosage Form: Ghrita, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Patients in the age group 18-50 years irrespective of sex, caste, religion.
2.Patients having minimum three symptoms of Dry Eye (Due to Excessive use of Visual Display Terminal (VDT) Gadgets.
3.Minimum 1 hour exposure to any type of Visual Display Terminal (VDT) like desktop,
laptop or mobile screens.
4.Patients having minimum 2 findings of below tests:
a.Schirmer strip wetting of between 1-15 mm in 5 minutes Schirmer- I test.
b.The appearance of dry spot between 1-15 seconds- Fluorescein Tear Film Break Up Test (F-TBUT).
c.Mild to Severe Staining (Superficial to dense staining) - Fluorescein Staining.
d.Mild to Severe Staining (Dot count 1-30) - Rose Bengal Staining (Oxford scheme of scoring) 
 
ExclusionCriteria 
Details  1.Age less than 18 years and more than 50 years.
2.Dry Eye due to any local cause e.g., Allergic Conjunctivitis, Xerosis etc.
3.Dry Eye due to systemic disease like Sjogren’s Syndrome.
4.Patients on Steroids, Oral Contraceptive Pills, Estrogen Replacement Therapy or any other medication such as Antispasmodic drugs like Atropine that may adversely affect the
outcome of the study.
5.Persistent contact lens users.
6.Patients having chronic debilitating diseases like HIV, Tuberculosis, Malignancy,
uncontrolled Diabetes Mellitus and Hypertensive. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief in Signs and Symptoms of Dry Eye (Due to excessive use of Visual Display Terminal (VDT) gadgets).   Relief in Signs and Symptoms of Dry Eye (Due to excessive use of Visual Display Terminal (VDT) gadgets) within 4-6 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Relief in Signs and Symptoms of Dry Eye (Due to excessive use of Visual Display Terminal (VDT) gadgets)   Relief in Signs and Symptoms of Dry Eye (Due to excessive use of Visual Display Terminal (VDT) gadgets) with in 4-6 weeks. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   02/05/2022 
Date of Study Completion (India) 24/02/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Introduction: Dry eye is not a disease entity, but a symptom complex occurring as a sequela to deficiency or abnormalities of the tear film. One of the causes of Dry Eye is excessive use of computer and Visual Display Terminal (VDT). Dry Eye (Due to excessive use of Visual Display Terminal (VDT) Gadgets) is characterized by symptoms like Dry eyes, Eye strain, Burning sensation in eyes, Foreign body sensation or gritty sensation in the eyes, Itching in eyes, Headache. Prevalence rate of Dry Eye in India (Patients with 4 hour or more of visual display terminal (VDT) usage) is 89.98%. Significance: No remedial measures for the prevention and cure of this pathology prevail in the domain of modern medicine except using ocular surface lubricants, computer glasses and counselling for minimum computer use.Though lubricating drops can reduce the effects of Dry Eye, but doesn’t break the root of pathogenesis of the disease, Ayurveda medicine mainly focus on treating the disease from its root cause. Till now no study was conducted to INSTITUTE OF TEACHING AND RESEARCH IN AYURVEDA to assess the efficacy of Shunthyadi Aschyotana (Eye Drop) with Mahatriphaladi Ghrita Pana. Hence, a clinical study is proposed to evaluate the efficacy of Shunthyadi Aschyotana topically and Mahatriphaladi Ghrita internally in Dry Eye (Due to excessive use of Visual Display Terminal (VDT) Gadgets). Materials and Methods: Minimum 30 patients will be enrolled on the basis of symptoms of Dryness of Eyes (Vishushkatwa), Eye Strain (Akshi Daurbalya), Foreign body sensation in eyes (Gharsha), Itching in Eyes (Kandu), Burning sensation in eyes ( Daha ), Headache (Shirah Shoola).Group A patients will receive interventions Shunthyadi Aschyotana (Eye drop) and Mahatriphaladi Ghrita (Orally), Group B patients will receive interventions Shunthyadi Aschyotana (Eye drop). Results and Discussion: Data generated during the above study will be presented in a systemic manner and shall be analysed statistically. Follow up: After completion of therapy, follow up will be done for 1 month to assess the status of patient, where patient will be asked to report fortnightly. Adverse effects: This proposal will be reviewed and approved by I.T.R.A., Institutional Ethics Committee, which is having the responsibility to protect the research participants from harm. These drugs have no known unwanted effects. It is possible that it may also cause some problems that we are not aware of. Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance cell of I.T.R.A. 
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