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CTRI Number  CTRI/2024/07/070970 [Registered on: 22/07/2024] Trial Registered Prospectively
Last Modified On: 18/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To see the effect of Netra Parisheka and Aschyotana along with Mahatriphaladi Ghrit in Vataj Abhishyanda. 
Scientific Title of Study   Comparative clinical evaluation of Netra Parisheka and Aschyotana along with Mahatriphaladi Ghrit in Vataj Abhishyanda. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sarita 
Designation  Postgraduate Scholar 
Affiliation  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar  
Address  OPD No.1,Patanjali Ayurved Hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Delhi Roorki Highway, Haridwar, India

Hardwar
UTTARANCHAL
249405
India 
Phone  9034475622  
Fax    
Email  saritasandhu14@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Daya Shankar Singh 
Designation  Professor 
Affiliation  patanjali bhartiya ayurvigyan evam anusandhan sansthan haridwar  
Address  OPD No 1, Department of Shalakya Tantra, Patanjali Ayurved Hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar Delhi Highway, Haridwar

Hardwar
UTTARANCHAL
249405
India 
Phone  8194028515  
Fax    
Email  dayaayush@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sarita 
Designation  PG Scholar 
Affiliation  Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan Haridwar  
Address  OPD No 1,Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan Haridwar

Hardwar
UTTARANCHAL
249405
India 
Phone  9034475622  
Fax    
Email  saritasandhu14@gmail.com  
 
Source of Monetary or Material Support  
Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan Haridwar  
 
Primary Sponsor  
Name  Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan Haridwar  
Address  Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan Haridwar Uttarakhand 249405 
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 
Sarita  Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan Haridwar   OPD No.1,Shalakya Tantra Department Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan
Hardwar
UTTARANCHAL 		 9034475622

saritasandhu14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Patanjali bhartiya ayurvigyan evam anusandhan sansthan haridwar   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H108||Other conjunctivitis. Ayurveda Condition: ABISHYANDAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-AScyotanam, आश्च्योतनम् (Procedure Reference: sharangdhar 13/18, Procedure details: eye drop)
(1) Medicine Name: bilwa gambhari paatala agnimantha shyonaka brahati erenda shigru, Reference: sharangdhar 13/18, Route: Ocular, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 10(drops), Frequency: bd, Duration: 7 Days
2Comparator ArmProcedure-pariSheka, परिषेक (Procedure Reference: sharangdhar 13/7-8, Procedure details: local eye wash by medicated kwatha.)
(1) Medicine Name: haridra, daruharidra,lavan,goo-dugdh, Reference: sharangdhar 13/7-8, Route: Ocular, Dosage Form: Kwatha/Kashaya, Dose: 1000(ml), Frequency: bd, Duration: 7 Days
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Subjects with classical symptoms of Vataj abhishyanda.
2.Subjects within the age of 6-50 years of either sex.
3.Subjects who are fit for Netra Parisheka and Aschyotana. 
 
ExclusionCriteria 
Details  1.Subjects having complications like corneal involvement, Dacryocystitis, Trachoma, Keratoconjunctivitis.
2.Subjects below 6 years and more than 50 years.
3.Other than simple allergic conjunctivitis.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Pricking pain (Nistoda)
2.Foreign body sensation (Sangharsha)
3.Watery discharge (Shishirashruta)
4.Feeling of dryness (Visuskabhava)
5.Headache (Shiroabhitapa)
6.Itching (kandu)
7.Oedema of lids (Akshi shopha)
 		 45,15,15 days 
 
Secondary Outcome  
Outcome  TimePoints 
1.Eosinophil count
2.Redness (Assessed by Efron grading scale)
a)Conjunctival redness
b)Limbal redness
 		 45,15,15 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 
Date of First Enrollment (India)   31/07/2024 
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   In this trial we are selecting the patients of vataj abhishyanda in which we will do the intervention in two groups 30 patients in each group.In the group we will intervene with ayurvedic therapy of Netra parisheka along with Mahatriphaladi ghrita for 45 days where as in other group we will intervene with ayurvedic therapy of Aschyotana along with Mahatriphaladi ghrita for 45 days.
Assessment should be done on the basis of subjective and objective parameters and investigations done during pre treatment and post treatment as discussed earlier. 
 
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