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CTRI Number  CTRI/2025/04/084186 [Registered on: 04/04/2025] Trial Registered Prospectively
Last Modified On: 29/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study On The Effect of Mrudweeka Eye Drops For Dry Eyes 
Scientific Title of Study   A Randomized Open Label Controlled Clinical Study To Evaluate The Efficacy Of Mrudweeka Arka Aschyotana In The Management Of Shushkakshipaka With Special Reference To Computer Vision Syndrome 
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 Kshama Jain 
Designation  Pg Scholar 
Affiliation  Sri Sri College Of Ayurvedic Science And Research, Bengaluru 
Address  Department Of Shalakya Tantra, Room Number 6, Sri Sri College Of Ayurvedic Science And Research Hospital, 21st K. M, Kanakapura Road, Udayapura, Bengaluru, Karnataka

Bangalore
KARNATAKA
560082
India 
Phone  9902284656  
Fax    
Email  kshamajain2610@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Geetha Kumari B 
Designation  Professor  
Affiliation  Sri Sri College Of Ayurvedic Science And Research, Bengaluru 
Address  Department Of Shalakya Tantra, Room No 6,Sri Sri College Of Ayurvedic Science And Research Hospital, 21st K. M, Kanakapura Road, Udayapura, Bengaluru, Karnataka

Bangalore
KARNATAKA
560082
India 
Phone  9480056218  
Fax    
Email  ayurgeeta@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Geetha Kumari B 
Designation  Professor  
Affiliation  Sri Sri College Of Ayurvedic Science And Research, Bengaluru 
Address  Department Of Shalakya Tantra, Room No 6, Sri Sri College Of Ayurvedic Science And Research Hospital, 21st K. M, Kanakapura Road, Udayapura, Bengaluru, Karnataka

Bangalore
KARNATAKA
560082
India 
Phone  9480056218  
Fax    
Email  ayurgeeta@gmail.com  
 
Source of Monetary or Material Support  
Sri Sri College Of Ayurvedic Science And Research Hospital, 21st K. M, Kanakapura Road, Udayapura P.O, Bengaluru -560082, Karnataka, India  
 
Primary Sponsor  
Name  Dr Kshama Jain 
Address  Sri Sri College Of Ayurvedic Science And Research Hospital, 21st K. M, Kanakapura Road, Udayapura, Bengaluru, Karnataka 
Type of Sponsor  Other [Self] 
 
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 Kshama Jain  Sri Sri College Of Ayurvedic Science And Research ,Hospital  Department Of Shalakya Tantra, Room No 6, Sri Sri College Of Ayurvedic Science And Research Hospital, 21st K. M, Kanakapura Road, Udayapura P.o, Bengaluru-560082, Karnataka, India
Bangalore
KARNATAKA 		 09902284656

kshamajain2610@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Sri Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H045||Stenosis and insufficiency of lacrimal passages. Ayurveda Condition: SUSHKAKSHIPAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Mrudweeka Arka, Reference: Bhavaprakasha Nigantu, Route: Topical, Dosage Form: Arka, Dose: 12(drops), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Punarnava Arka, Reference: Arka Prakasha, Route: Topical, Dosage Form: Arka, Dose: 12(drops), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Subjects within the age group between 21 to 40 years irrespective of gender, caste, religion, and socio-economic status.
Subjects having minimum of two symptoms as per diagnostic criteria.
Subjects who are employed professionals with screen time of more than two hours per day during the use of VDT (computers) with history of twelve months.
Subjects willing to participate in the study with informed consent.
 
 
ExclusionCriteria 
Details  Subjects with history of any intraocular surgery.
Subjects having any ocular trauma.
Subjects diagnosed with cases of any systemic and autoimmune disorders.
Subjects diagnosed with inflammatory and infective ocular conditions.
Subjects diagnosed with conditions like Cataracts, Corneal opacity, Keratoconus and Glaucoma.
Subjects with Drug induced dry eyes.
Subjects with Congenital lacrimal gland agenesis.
Subjects who are pregnant and lactating women.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Significant improvement in the signs and symptoms of Shushkakshipaka.
Significant improvement in the signs and symptoms of Computer vision syndrome.
 		 Pre-assessment - 0th day
1st assessment – 7th day
2nd assessment - 23rd day
Post treatment - 30th day
Follow up - 45th day
 
 
Secondary Outcome  
Outcome  TimePoints 
Generation of in-depth analyzed data on the different aspects of the disease.
Generation of data on possible adverse drug reactions.
 		 Pre-assessment - 0th day
1st assessment – 7th day
2nd assessment - 23rd day
Post treatment - 30th day
Follow up - 45th day
 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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/ Phase 3 
Date of First Enrollment (India)   01/05/2025 
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 Yet Recruiting 
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  

Shushkakshipaka is one among the Sarvagata Netra Rogas mentioned by Acharya Sushrutaas well as Vagbhata under Sadhya Netra Roga, caused by Vata and Pitta.

The Lakshanas of Shushkakshipaka according to Acharya Vagbhata are Gharsha, Toda, Bheda, Upadeha, Ruksha, Daruna Vartma, Krichronmeela, Krichra Nimeela, Akshi Vilokana, Shushkatwa, Sheeta Iccha, Shoola and Paka and Acharya Sushruta mentioned Lakshanas like Koonita Akshi, Daruna Vartma, Rookshatwa, Avila Darshanam and Krichronmeelanam.

The signs and symptoms of Shushkakshipaka can be considered similar to those of Computer vision syndrome.

Computer Vision Syndrome (CVS) is defined as a complex of eye and vision problems related to the activities which stress the near vision and which are experienced in relation to or during the use of computers. It encompasses a group of visual symptoms which crop up from the extended viewing of the Video Display Terminal (VDT), when the demands of the task exceed the abilities of the viewer.

Prevalence of CVS is found to be 88%  in the people who use computers everyday.

Symptoms of CVS includes dry and irritated eyes, eye strain/fatigue, blurred vision, red eyes, burning eyes, excessive watering, double vision, headache, light sensitivity, glare sensitivity, slowness in changing focus and changes in color perception.

The effect of the CVS has resulted in low performance and extreme discomfort to the sufferer.

The symptoms being vague and slow in onset, leads to intolerable severity by the time the sufferer seeks medical advice.

The use of artificial tears or contact lens wetting solutions is said to be the line of treatment. But with these treatments, the patients of CVS get only symptomatic relief for hours and slowly the frequency of the application to be increased.

Aschyotana is a Netrakriyakalpa, which is indicated in the initial stage of eye diseases which relieves Ruk, Toda, Kandu, Gharsha, Ashru, Daha and Raga.It is a method of instilling the medicated drops into the eye, which penetrates into the channels of Netrasandhi, Sira, Ghrana and Mukha of the Urdhwagabhaga and removes the Prakupita Dosha.Dravyas which are having Madhura Rasa, Snigdha Guna and Madhura Vipaka are advised in Shushkakshipaka.

Arka is considered as Gunotthamma according to Arka Prakasha which are Laghupaki, Vyavayi and Vikasi. Hence the active principles of the drug act quickly on the eye.

The contact time and the absorption of drug in the eye are enhanced by instilling drug with high potency and its shelf life of one year makes it a suitable choice of non-preservative topical drug.

The properties of Mrudweeka which is taken as the trial drug has Madhura, Kashaya Rasa, Sheeta-Guru guna, Madhura Vipaka and it is Chakshushya 

Hence in the present study, an effort will be made to evaluate efficacy of Mrudweeka Arka Aschyotana in  the management of  Shushkakshipaka with special reference to Computer vision syndrome.

 

 
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