FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/090442 [Registered on: 08/07/2025] Trial Registered Prospectively
Last Modified On: 07/07/2025
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   To study the effect of an Ayurvedic Formulation in the form of eyedrops(yahtimadhu ghrita aschyothana)and an Ayurvedic formulation for nasal application(Anutaila Prathimarsha nasya)in patients having Dry Eye Disease 
Scientific Title of Study   A Randomized open label clinical trial to evaluate the efficacy of Yashtimadhu ghrita Aschyothana and Anutaila Prathimarsha Nasya in Shushkakshipaka with special reference to Dry Eye Disease 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Athira P 
Designation  MD Scholer 
Affiliation  Banaras Hindu University 
Address  Department of Shalakya Tantra Faculty of Ayurveda IMS BHU Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9895166857  
Fax    
Email  Drathirapanangavil@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mridulata Maurya 
Designation  Assistant Professor 
Affiliation  Banaras Hindu University 
Address  Department of Shalakya Tantra Faculty of Ayurveda IMS BHU Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9456914468  
Fax    
Email  mridulata@bhu.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Mridulata Maurya 
Designation  Assistant Professor 
Affiliation  Banaras Hindu University 
Address  Department of Shalakya Tantra Faculty of Ayurveda IMS BHU Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9456914468  
Fax    
Email  mridulata@bhu.ac.in  
 
Source of Monetary or Material Support  
Department of Shalakya Tanta Faculty of Ayurveda IMS BHU Varanasi Uttar Pradesh India Pincode 221005 
 
Primary Sponsor  
Name  Faculty of Ayurveda Institute of Medical Sciences BHU  
Address  Department of Shalakya Tantra Faculty of Ayurveda IMS BHU Varanasi Uttar Pradesh India Pincode 221005 
Type of Sponsor  Government medical college 
 
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 Athira P  Sir Sunderlal Hospital IMS BHU  Room no 13 OPD ofDepartment of Shalakya Tantra Faculty of Ayurveda IMS BHU and OPD of Ophthalmology S S Hospital IMS BHU
Varanasi
UTTAR PRADESH 		 9895166857

Drathirapanangavil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Banaras Hindu University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H041||Other disorders of lacrimal gland. Ayurveda Condition: SUSHKAKSHIPAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Carboxymethyl cellulose 1% eye dropsCarboxymethyl cellulose is cellulose derivative with carboxymethyl group,is one of the most common lubricant and viscosity enhancing agents used as artificial tears.
2Intervention ArmProcedure-AScyotanam, आश्च्योतनम् (Procedure Reference: Susruta Samhita Uttarasthana Kriyakalapadhyaya, Procedure details: The lower eyelid are opened by the left hand,then the Yashtimadhu ghrita is instilled into the inner canthus of the conjunctival sac .)
(1) Medicine Name: Anutaila, Reference: Ashtanga Hridaya Sutrasthana Nasya vidhi adhyaya, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 30 Days
(2) Medicine Name: Yashtimadhu ghrita, Reference: Susruta samhita Uttarasthana Vatabhishyanda pratishedha, Route: Ocular, Dosage Form: Ghrita, Dose: 2(drops), Frequency: bd, Duration: 30 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients presenting with signs and symptoms of Dry eye Disease.
2.TBUT smaller than or equal to 5 seconds.
3.Schirmers test smaller than or equal to 10 mm. 
 
ExclusionCriteria 
Details  1. Cases complicated with acute, chronic, infective conjunctivitis or any specific eyelid
disorder, corneal ulcer, dacryocystitis and lagophthalmos.
2. Contact lenses use.
3. History of ocular surgery within 6 months prior to enrolment in trial.
4. Pregnancy or child bearing age without contraception.
5. Patient who starts developing complications will be excluded from the study.
6. Patient not willing for the treatment.
7. Ongoing ocular or systemic infection.
8. Ocular or periocular malignancy.
9. Lid structural abnormality.  
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in Ocular Surface Disease Index(OSDI) score from baseline in parameters
Change in Tear Film Break-up Time(TFBUT) 		 Change in Ocular Surface Disease Index(OSDI) score from baseline in parameters
Change in Tear Film Break-up Time(TFBUT)

Assessed at 15th day,30th day and 45th day  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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   Phase 3 
Date of First Enrollment (India)   19/07/2025 
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="8"
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   This study is a randomized, controlled clinical trial in which 50 patients are selected as per the inclusion criteria and will be randomly divided into 2 groups .Treatment group will be given the Ayurvedic intervention ( Aschyothana with Yashtimadhu ghrita 2 drops BD and Prathimarsha nasya with Anutaila 2 drops morning ) and the other group will be given Carboxymethyl cellulose 1 %  eyedrops 4 times a day for 30 days for comparing the efficacy of these drugs in Shushkakshipaka with special reference to Dry Eye Disease . The result will be statistically analyzed. 
Close