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CTRI Number  CTRI/2024/10/074646 [Registered on: 03/10/2024] Trial Registered Prospectively
Last Modified On: 26/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Other 
Public Title of Study   A Study to clinically evaluate Mustadi Seka, Yoganjana and Shirolepa in Praklinna Vartma(Seborrhoeic Blepharitis)  
Scientific Title of Study   An open - randomized clinical study to evaluate the combined effect of Mustadi Seka, Yoganjana and Shirolepa in Praklinna Vartma (Seborrhoeic Blepharitis)  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrPriyanka Rani  
Designation  Professor 
Affiliation  Rishikul Campus UAU  
Address  OPD no.5 and IPD of Shalakya Tantra Department Rishikul Campus Uttarakhand Ayurved University Haridwar
OPD No 5 and IPD of Shalakya Tantra Dept. Rishikul Campus UAU Haridwar Uttaranchal India Hardwar Uttaranchal 249401
Hardwar
UTTARANCHAL
249401
India 
Phone  7500402154  
Fax    
Email  chauhanpriyanka40@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrPriyanka Rani  
Designation  Professor 
Affiliation  Rishikul Campus UAU  
Address  OPD no.5 and IPD of Shalakya Tantra Department Rishikul Campus Uttarakhand Ayurved University Haridwar
OPD No. 5 and IPD of Shalakya Tantra Department Rishikul Campus UAU Haridwar Uttaranchal India Haridwar UTTARANCHAL 249401
Hardwar
UTTARANCHAL
249401
India 
Phone  7500402154  
Fax    
Email  chauhanpriyanka40@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shruti Vaishnava  
Designation  PG Scholar  
Affiliation  Rishikul Campus UAU 
Address  OPD no. 5 and IPD Of Shalakya Tantra Department Rishikul Campus Uttarakhand Ayurved University Haridwar

Hardwar
UTTARANCHAL
249401
India 
Phone  8006094679  
Fax    
Email  shrutivaishnava70698@gmail.com  
 
Source of Monetary or Material Support  
Rishikul Campus Uttarakhand Ayurved University  
 
Primary Sponsor  
Name  Rishikul Campus Uttarakhand Ayurved University  
Address  Rishikul Campus Uttarakhand Ayurved University Haridwar  
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 
DrShruti Vaishnava   Rishikul Campus Uttarakhand Ayurved University Haridwar   OPD No.5 and IPD of Shalakya Tantra Department
Hardwar
UTTARANCHAL 		 8006094679

shrutivaishnava70698@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: NETRAROGAH/AKSHIROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Mustadi Seka, Yoganjana, Shirolepa , Reference: Sushruta Samhita and Rastantra sara evam siddhaprayoga Sangraha , Route: Ocular, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with classical sign and symptoms of Praklinn Vartma (Seborrhoeic Blepharitis) .Patient of age group 12 to 60 years of either sex will be taken in this study . 
 
ExclusionCriteria 
Details  Patient having diseases like corneal ulcers ,dacryocystitis ,dry eye,lagophthalmos ,infective conjunctivitis etc.
Patients suffering from specific eyelid disorders like ectropion ,entropion ,trichiasis ,tumours,carcinoma ,skin allergies
Systemic Diseases like Diabetes Mellitus ,Hypertension . 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To Study The Conceptual Resemblance Between Praklinna Vartma and Seborrhoeic Blepharitis   To Study The Conceptual Resemblance Between Praklinna Vartma and Seborrhoeic Blepharitis  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate combined effect of Mustadi Seka ,Yoganjana and Shirolepa in Praklinna Vartma  21 days 
 
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 1 
Date of First Enrollment (India)   08/10/2024 
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   This study will be performed to evaluate the combined effect of Mustadi Seka , Yoganjana and Shirolepa in Praklinn Vartma (Seborrhoeic Blepharitis ) .Patients fulfilling the diagnostic criteria of Praklinna Vartma will be taken in the study . The status of the patient will be recorded on the day of enrollment on the basis of parameters taken in the study and response of Mustadi Seka ,Yoganjana ,Shirolepa will be recorded after the completion of study .The study will access the role of Mustadi Seka , Yoganjana and Shirolepa in the management of Praklinn Vartma  (Seborrheic Blepharitis). 
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