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CTRI Number  CTRI/2024/03/064841 [Registered on: 27/03/2024] Trial Registered Prospectively
Last Modified On: 11/03/2024
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   Effect of Saindhavadi Anjana in Dry Eye Disease  
Scientific Title of Study   Randomized, open-label, pilot clinical trial to evaluate the efficacy of Saindhavadi Anjana in Meibomian Gland Dysfunction (MGD) associated Dry Eye Disease (DED) 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nilkanthe Anuradha Gulabrao 
Designation  M.S.(Ayu)scholar  
Affiliation  Institute of Medical Sciences, Banaras Hindu University  
Address  Room no 13 Shalakya Tantra OPD Indian medicine wing Sir sunderlal hospital IMS BHU Varanasi 221005

Varanasi
UTTAR PRADESH
221005
India 
Phone  8788377303  
Fax    
Email  anuradhanilkanthe@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Manoj Kumar 
Designation  Professor  
Affiliation  Institute of Medical Sciences, Banaras Hindu University  
Address  Room no 13 Shalakya Tantra OPD Indian medicine wing Sir sunderlal hospital IMS BHU Varanasi 221005

Varanasi
UTTAR PRADESH
221005
India 
Phone  9793127744  
Fax    
Email  mkumarbhu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nilkanthe Anuradha Gulabrao 
Designation  M.S.(Ayu)scholar 
Affiliation  Institute of Medical Sciences, Banaras Hindu University  
Address  Room no 13 Shalakya Tantra OPD Indian medicine wing Sir Sunderlal Hospital IMS BHU Varanasi 221005

Varanasi
UTTAR PRADESH
221005
India 
Phone  8788377303  
Fax    
Email  anuradhanilkanthe@gmail.com  
 
Source of Monetary or Material Support  
Institute of Medical Sciences, Banaras Hindu University  
 
Primary Sponsor  
Name  None 
Address  None 
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 
Anuradha Gulabrao Nilkanthe   Sir Sundarlal Hospital Institute of Medical Sciences Banaras Hindu University Varanasi 221005  Room no 13 Shalakya Tantra OPD Indian Medicine Wing Sir Sunderlal Hospital Institute of Medical Sciences Banaras Hindu University Varanasi 221005
Varanasi
UTTAR PRADESH 		 8788377303

anuradhanilkanthe@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, IMS, BHU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H578||Other specified disorders of eye and adnexa. Ayurveda Condition: SUSHKAKSHIPAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Carboxymethyal cellulose , Reference: NA, Route: Topical, Dosage Form: , Dose: 1(drops), Frequency: qid, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 30 Days, Reference: NA, Route: -, Dosage Form: , Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
2Intervention ArmProcedure-a~jjanam, अंजनम् (Procedure Reference: Ashtanga Hridayam Sutrastan, Procedure details: Saindhvadi Anjana will be applied over the lid margin from medial canthus to lateral canthus followed by prakshalana (wash) with clean water)
(1) Medicine Name: Saindhvadi Anjana , Reference: Sushruta Samhita Uttartantra , Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(mg), Frequency: od, Duration: 30 Days
3Comparator Arm (Non Ayurveda)-Azithromycin 1% ointmentAzithromycin 1% ointment once in the evening
4Comparator Arm (Non Ayurveda)-Carboxy methyl cellulose 0.5% eye dropCarboxymethyl cellulose 0.5% eye drops 4 times/day for 30 days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Signed ICF (Informed Consent Form)
Patients presenting with signs and symptoms of Shushkakshipaka
Patients presenting with signs of MGD
Ocular dryness
Meibomian gland orifice plugging
Lid margin telangiectasia
TBUT less than 5 seconds
Schirmer’s test less than 10mm 
 
ExclusionCriteria 
Details  Cases complicated with acute, chronic, infective conjunctivitis or any specific eyelid disorder, corneal ulcer, dacryocystitis and lagophthalmos
Inflammatory diseases unrelated to MGD
Patients suffering from any systemic disorder or taking any medications which in the
opinion of PI may affect the clinical outcome of the trial
Contact lenses use
History of ocular surgery within 6 months prior to enrolment in trial
Pregnancy or child bearing age without contraception
Stevens-Johnson syndrome
Chemical, thermal or radiation injury
Sjogren’s syndrome
Patient who starts developing complications will be excluded from the study
Patient not willing for the treatment
Ongoing ocular or systemic infection
Ocular or periocular malignancy
Use of topical steroids, topical cyclosporine, topical anti-glaucoma medication within 60 days before screening
Lid structural abnormality not caused by MGD 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in OSDI score from baseline   30 Days 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   01/04/2024 
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 - NO
Brief Summary  
Dry eye is a multi-factorial disease of the ocular surface characterized by loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles. Conventional treatment modalities of MGD only provide symptomatic relief and treatment like Intense Pulse Light (IPL) can be economic burden for patients. This study will be conducted in patients presenting with signs and symptoms of Shushkakshipaka. Patients presenting with signs of MGD, TBUT <5 seconds and Schirmer’s test <10mm.
Saindhavadi Anjana will be applied once daily in evening followed by prakshalana with clean water and Carboxymethyl cellulose 0.5% eye drops 4 times /day in intervention group. Azithromycin 1% eye ointment once in evening daily and Carboxymethyl cellulose 0.5% eye drops 4 times/day will be applied in control group. All the parameters will be analysed by applying appropriate parametric or non- parametric tests for comparison.

 
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