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CTRI Number  CTRI/2022/02/040266 [Registered on: 14/02/2022] Trial Registered Prospectively
Last Modified On: 03/12/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study on preventive action of Ayurvedic medicine in Covid 19. 
Scientific Title of Study   A Randomized Comparative Open-Ended Clinical Study to Evaluate the Role of Matulungadi nasya in the Prophylaxis of COVID-19 Disease w.s.r to youngsters 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shyam Prasad M 
Designation  Professor, Kayachikitsa-Head of Department 
Affiliation  Parassinikkadavu Ayurveda medical college 
Address  MVR Ayurveda medical college( old name-Parassinikkadavu Ayurveda medical college) Parassinikkadavu Kannur Kerala

Kannur
KERALA
670563
India 
Phone  9496192409  
Fax    
Email  getshyampm@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Shyam Prasad M 
Designation  Professor, Kayachikitsa-Head of Department 
Affiliation  Parassinikkadavu Ayurveda medical college 
Address  MVR Ayurveda medical college( old name-Parassinikkadavu Ayurveda medical college) Parassinikkadavu Kannur Kerala

Kannur
KERALA
670563
India 
Phone  9496192409  
Fax    
Email  getshyampm@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Shyam Prasad M 
Designation  Professor, Kayachikitsa-Head of Department 
Affiliation  Parassinikkadavu Ayurveda medical college 
Address  MVR Ayurveda medical college( old name-Parassinikkadavu Ayurveda medical college) Parassinikkadavu Kannur Kerala

Kannur
KERALA
670563
India 
Phone  9496192409  
Fax    
Email  getshyampm@yahoo.co.in  
 
Source of Monetary or Material Support  
MVR Ayurveda medical college, Parassinikadavu P O, Kannur District-670563, Kerala 
 
Primary Sponsor  
Name  Pappiniseeri Visha Chikitsa Kendram 
Address  Pappiniseeri Vish Chikitsa Kendram PO. Pappinisseri Kannur Dt, 670561 
Type of Sponsor  Other [Non governmental, charitable institution] 
 
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 Shyam Prasad M  MVR Ayurveda Medical college hospital  Op Building, Kayachikitsa- Unit 2, Romm no-10,Parassinikadavu-670563 Kannur, Kerala
Kannur
KERALA 		 9496192409

getshyampm@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MVR Ayurveda medical college Parassinikadavu Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Study is on healthy human volunteers on effectiveness of Ayurvedic formulation in preventing Covid 19 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-pratimarSaH, प्रतिमर्श (Procedure Reference: Ashtanga hridaya, Sutra sthana, Nasya vidhi chapter, Procedure details: Matulungadi nasya procured from MVR Ayurveda Hospital Pharmacy, 2 drops in each nostril at bed time which should be 3 hours after food. For seven days on every day basis and after that once on 14th, 21st and 28th day.)
(1) Medicine Name: Matulunga taila, Reference: Yogaratnakara, Jwara chikitsa adhyaya, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 7 Days
2Comparator Arm (Non Ayurveda)-No medicineParticipants of this group will be not receiving any medicine. As the study is on healthy volunteers, this is not unethical
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Healthy volunteers (status of health will be assessed as per Ayurvedic criteria of swasthya)
Young subjects who have high chances exposure to Covid-19cases
Those with negative (non reactive) SARS Covid-19 on RTPCR
Who are ready to participate and give informed consent
•Age group of 18 to 30 irrespective of sex
 
 
ExclusionCriteria 
Details  Those suffering with immune compromised conditions
Those suffering with serious systemic illness
If the co morbidity are present
Those with positive ( reactive) test result on rapid antibody test for SARS Covid-19 or RTPCR
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
negative RTPCR  six weeks 
 
Secondary Outcome  
Outcome  TimePoints 
non appearance of covid symptoms  six weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   19/02/2022 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Nil 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code
    Response (Others) -  nil
  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [getshyampm@yahoo.co.in].

  6. For how long will this data be available start date provided 30-06-2022 and end date provided 30-06-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This study is a randomized comparative open ended clinical study to evaluate the role of Mathulungadi nasya in prophylaxis of covid-19 w.s.r to youngsters. The study will be conducted at MVR Ayurveda medical college(Parassinikadavu Ayurveda medical college-old name). The study includes two groups, one trial group and another zero control. The trial group will be on Mathulungadi nasya 2 dorps in each nostril, daily for one week, there after once on 14th, 21st and 28th day.  The follow up will be done after two weeks from the 28th day. the outcomes will be evaluated by RTPCR
 
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