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CTRI Number  CTRI/2023/02/050140 [Registered on: 27/02/2023] Trial Registered Prospectively
Last Modified On: 17/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study effect of triphala decoction sac syringing and normal saline sac syringing in management of chronic dacryocystitis. 
Scientific Title of Study   Randomized controlled clinical trial to study the efficacy of triphala kwath sac syringing and normal saline sac syringing in management of chronic dacryocystitis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shalaka Sambhus 
Designation  MS Scholar Shalakyatantra 
Affiliation  Tilak Ayurveda Mahavidyalaya 
Address  Tilak Ayurveda Mahavidyalaya Department of Shalakyatantra 2nd floor 583/2 Rasta Peth Pune
583/2 Rasta Peth Pune
Pune
MAHARASHTRA
411011
India 
Phone  8600436303  
Fax    
Email  shalaka.sambhus@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prakash Guddimath 
Designation  Associate Professor Shalakyatantra Department 
Affiliation  Tilak Ayurveda Mahavidyalaya 
Address  Tilak Ayurveda Mahavidyalaya Department of Shalakyatantra 2nd floor 583/2 Rasta Peth Pune
583/2 Rasta Peth Pune
Pune
MAHARASHTRA
411011
India 
Phone  9527545122  
Fax    
Email  drprakashig@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shalaka Sambhus 
Designation  MS Scholar Shalakyatantra 
Affiliation  Tilak Ayurveda Mahavidyalaya 
Address  Tilak Ayurveda Mahavidyalaya Department of Shalakyatantra 2nd floor 583/2 Rasta Peth Pune
583/2 Rasta Peth Pune
Pune
MAHARASHTRA
411011
India 
Phone  8600436303  
Fax    
Email  shalaka.sambhus@gmail.com  
 
Source of Monetary or Material Support  
Seth Tarachand Ramnath Charitable Ayurvedic Hospital 
 
Primary Sponsor  
Name  Tilak Ayurveda Mahavidyalaya 
Address  Tilak Ayurveda Mahavidyalaya Department of Shalakyatantra 2nd floor 583/2 Rasta Peth Pune 411011 
Type of Sponsor  Private 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 Shalaka Sambhus  Seth Tarachand Ramnath Ayurvedic Hospital Pune  Tilak Ayurveda Mahavidyalaya Department of Shalakyatantra Ophthalmology OPD 14 1st floor 583/2 Rasta Peth Pune
Pune
MAHARASHTRA 		 8600436303

shalaka.sambhus@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional ethical committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H048||Other disorders of lacrimal system. Ayurveda Condition: NETRAROGAH/AKSHIROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-netrapariSheka, नेत्रपरिषेक (Procedure Reference: Sarth Yogratnakara 42, Procedure details: Sac syringing is a technique use to check the nasolacrimal passage for any blockage or to flush out the debris from the passage)
(1) Medicine Name: Triphala, Reference: Bhavprakash Samhita 46, Route: Ocular, Dosage Form: Kwatha/Kashaya, Dose: 10(ml), Frequency: od, Duration: 7 Days
2Comparator Arm (Non Ayurveda)-normal salineNormal saline is 0.9% of sodium chloride every 100 ml of solution. It works as an antibiotic.
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients having symptoms of pain, swelling, watery discharge and congestion in eyes. 
 
ExclusionCriteria 
Details  Patients with acute infection in eyes.
Patients whose regurgitation test shows muco-purulent discharge.
Patients who have undergone cataract surgery within a month. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Sample size 50
decrease in pain, congestion, watering and swelling of eyes. 		 Sample size 50
decrease in pain, congestion, watering and swelling of eyes. 
 
Secondary Outcome  
Outcome  TimePoints 
Sample size 50
decrease in pain, congestion, watering and swelling of eyes. 		 3 months 
 
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)   28/02/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet done 
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 intervened by the treatment of triphala kwath sac syringing and normal saline sac syringing to group A and group B respectively. The efficacy of the therapy will be assessed on the basis of subjective criteria for statistical analysis. Scoring will be designed according to the severity of symptoms. The subjective gradation of symptoms will be done as follows and the intensity of each symptom will be calculated before treatment, after treatment and after follow up. The effect of treatment result will be assessed in regards to clinical signs and symptoms on the basis of grading and scoring system. The signs and symptoms will be assessed by adopting the suitable scoring method. 
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