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CTRI Number  CTRI/2023/03/050424 [Registered on: 07/03/2023] Trial Registered Prospectively
Last Modified On: 21/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A STUDY HELD TO SEE THE EFFECT OF NIMBADI BIDALAKA IN THE MANAGEMENT OF KRIMIGRANTHI (BLEPHARITIS) 
Scientific Title of Study   A SINGLE ARM CLINICAL STUDY TO EVALUATE THE EFFICACY OF NIMBADI BIDALAKA IN THE MANAGEMENT OF KRIMIGRANTHI (BLEPHARITIS) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kirti Kailasrao Sengaonkar 
Designation  MS Scholar Shalakya Tantra 
Affiliation  Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune  
Address  Department of shalakya tantra opd no.6 Ground flood Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri,Pune 411018 Maharashtra

Pune
MAHARASHTRA
411018
India 
Phone  8208921767  
Fax    
Email  sengaonkarkirti07@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Santosh Rahinj 
Designation  Assosciate Professor 
Affiliation  Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune  
Address  Department of shalakya tantra Opd no. 6 Ground floor Dr DY Patil College of Ayurveda and Research Centre Sant Tukaram Nagar Pimpri, Pune411018 Maharashtra

Pune
MAHARASHTRA
411018
India 
Phone  8600866097  
Fax    
Email  santoshrahinj@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Dr Santosh Rahinj 
Designation  Assosciate Professor 
Affiliation  Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune  
Address  Department of Shalakya Tantra Opd no.6 Ground floor Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune 411018 Maharashtra (411018)

Pune
MAHARASHTRA
411018
India 
Phone  8600866097  
Fax    
Email  santoshrahinj@yahoo.in  
 
Source of Monetary or Material Support  
Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra Pin 411018 
 
Primary Sponsor  
Name  Kirti Kailasrao Sengaonkar 
Address  Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra Pin 411018 
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 
Kirti Kailasrao Sengaonkar  Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune   Department of Shalakya Tantra Division Netra Roga OPD Ground Floor OPD Number 6 Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra Pin 411018
Pune
MAHARASHTRA 		 8208921767

sengaonkarkirti07@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:H010||Blepharitis. Ayurveda Condition: KRUMIGRANTHIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-biDAlaka:, बिडालक: (Procedure Reference: Sharangdhar Smahita Uttarkhand Chapter 13 Shloka 33, Procedure details: )
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 The Patients presenting sign and symptoms of
Krimigranthi with Itching of eyelids Burning sensation Lacrimation and white scales along the base of eyelashes
2 Between the age group 18 to 60 years 
 
ExclusionCriteria 
Details  1 Blepharitis associated with conjunctivitis and
Ulcerative Blepharitis
2 Patients suffering from Ptosis Psoriasis Drug induced Blepharitis
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Nimbadi Bidalaka is effective in the management of Krimigranthi (Blepharitis).  5 days with 2 follow up (0th day and 6th day) 
 
Secondary Outcome  
Outcome  TimePoints 
There is significant effect of Nimbadi Bidalaka on Krimigranthi (Blepharitis )   5 days with 2 follow ups (0th day and 6th day) 
 
Target Sample Size   Total Sample Size="31"
Sample Size from India="31" 
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)   01/04/2023 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The aim of the study is to see the efficacy of Nimbadi Bidalaka in reducing and management of the inflammation caused in Krimigranthi (Blepharitis).
The study will be completed with 31 patients showing sign and symptoms of Krimigranthi (Blepharitis).
The paste of medicine is applied over closed eyes of patient in circular form except on lid margin and eyelashes in the prescribed quantity for a duration of 5 days and assessment will be done 0th and 6th day. 
The  Conclusion would be drawn on the basis of statistical analysis and result would be interpreted accordingly
 
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