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CTRI Number  CTRI/2020/02/023648 [Registered on: 28/02/2020] Trial Registered Prospectively
Last Modified On: 26/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To check the effect of Shigrupatra pultis in yellow and whitish discharge, redness in eye, heaviness in eye 
Scientific Title of Study   Evaluation of the efficacy of Shigrupatra Pindi in Kaphaja Abhishyanda 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manjiri Keskar 
Designation  Professor 
Affiliation  Parul Institute of Ayurved 
Address  OPD-108, Parul Ayurved hospital Shalakya Tantra department Parul Ayurved Hospital Parul University post limda, Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9822606358  
Fax    
Email  manjirikeskar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Abhishek Shukla  
Designation  PG scholar 
Affiliation  Parul Institute of ayurved 
Address  OPD-108, Parul Ayurved hospital Shalakya Tantra department Parul Ayurved Hospital Parul University post limda,

Vadodara
GUJARAT
391760
India 
Phone  7000320257  
Fax    
Email  drabhishukla94@gmail.com  
 
Details of Contact Person
Public Query  
Name  Abhishek Shukla  
Designation  PG scholar 
Affiliation  Parul Institute of ayurved 
Address  OPD-108, Parul Ayurved hospital Shalakya Tantra department Parul Ayurved Hospital Parul University post limda, Vadodara

Vadodara
GUJARAT
391760
India 
Phone  7000320257  
Fax    
Email  drabhishukla94@gmail.com  
 
Source of Monetary or Material Support  
Parul Ayurved Hospital Parul University p.o.- Limda, pin- 391760 vadodara Gujarat  
 
Primary Sponsor  
Name  Dean Parul institute of Ayurved 
Address  Parul Institute of Ayurved Parul University Post Limda, Vadodara 
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 
Abhishek Shukla  Parul Ayurved Hospital  OPD-108 Department of Shalakya Tantra Parul Institute of Ayurved Parul University, post Limda pincode-391760
Vadodara
GUJARAT 		 7000320257

drabhishukla94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H108||Other conjunctivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Shigrupatra Pindi in Kaphaja Abhishyanda   Shigrupatra (moringa olifera) Pindi explained in Sharangdhara Uttara sthana 13/28. Shigrupatra are grinded into a paste,tied by a cloth and this pack kept on the eyes. Dose- 6gms approx local application DHarana Kala- 3 minutes approx Two times a day for 7 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having symptoms of Kaphaja Abhishyanda  
 
ExclusionCriteria 
Details  Patient suffering from specific conjunctival or systemic disease.
Patient with concorrent serious systemic illness like HTN,DM,Hepatitis.
Cases complicated with Trachoma and Corneal ulcer.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Symptoms like heaviness of eye, oedema of eye, itching, excessively stickiness, redness, lacrimation   7 days 
 
Secondary Outcome  
Outcome  TimePoints 
Relief from symptoms like heaviness of eye, oedema of eye, itching, excessively stickiness, redness, lacrimation   7 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/ Phase 2 
Date of First Enrollment (India)   02/03/2020 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Eye is the most important organ, if vision is lost, merely everything is lost. The eye is the window of soul and holds special importative among the sense organs, without vision the day and night are same and this beautiful world is useless even if one possesses planty of wealth. Abhishyanda is one among the SARVAGATA NETRA ROGA which affects all parts of eye. According to SUSHRUTA and other sages abhishyanda are of four types namely vataja, pittaja, kaphaja, and raktaja. In kaphaja abhishyanda the patient will feel heaviness, oedema, itching, decrease in temperature of eye, drowsiness, loss of appetite, white slime discharges and desire of warmth. Apart from this while describing the etiological factor of the disease trauma, unwholesome food and activities have also been added. Dust and smoke are indicative of allergic origin of Abhishyanda. The eye is full if tajas and has risk of troubles especially from Shleshma. Due to direct exposure towards heat, cold, sunlight, dust particles etc. the prevalence of abhishyanda is more. Hence there is a need to develop which is soothing, cost-effective and has a significant effect in alleviating the symptoms of the patient. 
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