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CTRI Number  CTRI/2024/09/074326 [Registered on: 25/09/2024] Trial Registered Prospectively
Last Modified On: 03/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the effect of an ayurvedic preparation Yashtimadhu-Madhu Parishek and Mrudu Swedan in the management of disease Anjannamika which is correlated with disease External Hordeolum in modern science. 
Scientific Title of Study   A Randomised Controlled Clinical study on the efficacy of “Yashtimadhu-Madhu Parishek” with “Mrudu Swedan” in management of Anjannamika with special reference to External Hordeolum 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aakansha Pradip Gorakh  
Designation  PG Scholar 
Affiliation  Vidarbha Ayurveda Mahavidyalaya, Amravati 
Address  OPD no 13, Shalakya Tantra Department, HVPM’S Vidarbha Ayurveda Mahavidyalaya, Farshi Stop, Amravati

Amravati
MAHARASHTRA
444606
India 
Phone  9869797927  
Fax    
Email  gorakh.aakansha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jyoti Ramrao Dakhore 
Designation  HOD and Associate Professor, Shalakya Tantra Department  
Affiliation  Vidarbha Ayurveda Mahavidyalaya, Amravati 
Address  OPD no 13, Shalakya Tantra Department, HVPM’S Vidarbha Ayurveda Mahavidyalaya, Farshi Stop, Amravati

Amravati
MAHARASHTRA
444606
India 
Phone  9011727497  
Fax    
Email  jyotidakhore23@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aakansha Pradip Gorakh  
Designation  PG Scholar 
Affiliation  Vidarbha Ayurveda Mahavidyalaya, Amravati 
Address  OPD No 13, Shalakya Tantra Department, HVPM’S Vidarbha Ayurveda Mahavidyalaya, Farshi Stop, Amravati

Amravati
MAHARASHTRA
444606
India 
Phone  9869797927  
Fax    
Email  gorakh.aakansha@gmail.com  
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  Dr Aakansha Pradip Gorakh 
Address  OPD no 13, Shalakya Tantra Department, Vidarbha Ayurveda Mahavidyalaya, Near Farshi Stop, Dastur Nagar, Amravati , Maharashtra, India, Pincode- 444606 
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 
Dr Aakansha Gorakh   Vidarbha Ayurveda Mahavidyalaya and GNT hospital   OPD No 13, Shalakya Tantra Department, Vidarbha Ayurveda Mahavidyalaya, Farshi Stop, Dastur Nagar, Amravati
Amravati
MAHARASHTRA 		 9869797927

gorakh.aakansha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vidarbha Ayurveda Mahavidyalaya Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H000||Hordeolum (externum) (internum) ofeyelid. Ayurveda Condition: VARTMA-ROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-snehanasekaH, स्नेहनसेकः svedan (Procedure Reference: Sushrut Samhita, Procedure details: Sthanik Snehan and Swedan of Patients done, Then Parishek done over closed eyelids for 7 days. Once during morning time.)
(1) Medicine Name: Yashtimadhu-madhu kwath, Reference: Ashtang Sangrah, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 500(ml), Frequency: od, Duration: 7 Days
2Comparator Arm (Non Ayurveda)-Moxifloxacin eye drop Instillation in affected eyeMoxifloxacin 0.5% w/v eye drop is used. It is instilled topically in the affected eye for the duration of 7 days. 1 drop is instilled in the affected eye 4 times per day for 7 days and result noted.
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Inclusion Criteria:
1) Patients of the age group between 15-50 years.
2) Patients having classical signs and symptoms of Anjannamika.
3) Patients were selected irrespective of sex, religion.
and occupation.
4) Patients willing to give consent for the procedure. 
 
ExclusionCriteria 
Details  Exclusion criteria:
1) Patients below 15 years of age and above 50 years of age.
2) Patients with other associated ocular diseases.
3) Recently eye operated patients.
4) Patients with other systemic disorders like
diabetes, hypertension, etc 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Pain, Tenderness, Inflammation, Watering of eyes, Congestion complaints of the patient resolved completely   0 day- 7th day - 15th day and 30th day 
 
Secondary Outcome  
Outcome  TimePoints 
Visual Acuity of patient improved   Within 7 days of starting of treatment  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   30/09/2024 
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="0"
Months="3"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [gorakh.aakansha@gmail.com].

  6. For how long will this data be available start date provided 28-09-2024 and end date provided 31-12-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Trial will be started 1 month from today. Patient selected according to the inclusion and exclusion criteria. Parishek procedure done for 7 days and Results observed and noted down. 
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