FULL DETAILS (Read-only)

CTRI Number  CTRI/2020/05/025222 [Registered on: 18/05/2020] Trial Registered Prospectively
Last Modified On: 20/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Trial 
Public Title of Study   Efficacy of Tablet AOIM - Z in Prevention of COVID - 19 in High Risk Healthy Police Personnel 
Scientific Title of Study   Evaluation of Clinical Efficacy of AOIM – Z Tablets for Prevention of COVID – 19 Pandemic in High Risk Healthy Police Personnel – Single Arm, Open Labelled, Prospective Exploratory Interventional Clinical Study 
Secondary IDs if Any  
Secondary ID  Registry 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Mahesh Kumar Harit 
Address  Department of Sankrit Samhita Siddhant, Second Floor, College Building D. Y. Patil Deemed to be University, School of Ayurveda, Nerul, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9322217607  
Fax    
Email  drmaheshkharit@rediffmail.com  
 
Details Contact Person
Scientific Query

Modification(s)  
Name  Dr Vinay Pawar 
Address  Department of Sankrit Samhita Siddhant, Second Floor, College Building D. Y. Patil Deemed to be University, School of Ayurveda, Nerul, Navi Mumbai

Thane
MAHARASHTRA
400060
India 
Phone  7506631982  
Fax    
Email  vinay.pawar@dypatil.edu  
 
Details Contact Person
Public Query

Modification(s)  
Name  Dr Vedvati Bhapkar 
Address  Department of Rasashastra & Bhaishajya Kalpana, School of Ayurveda, D. Y. Patil deemed to be University, Nerul east, Navi Mumbai
D. Y. Patil Deemed to be University, School of Ayurveda, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India 
Phone  9594830100  
Fax    
Email  drvedvati@gmail.com  
 
Source of Monetary or Material Support
Modification(s)  
Shree Dhootapapeshwar Limited 135 Nanubhai Desai Road Khetwadi Mumbai 400004 
 
Primary Sponsor  
Name  Shree Dhootapapeshwar Limited 
Address  135, Nanubhai Desai Road, Khetwadi, Mumbai – 400004 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Mahesh Kumar Harit  OPD no. 1, D. Y. Patil Ayurveda Hospital  Nerul east Navi Mumbai
Thane
 
9322217607

drmaheshkharit@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
IEC, School of Ayurveda, D. Y. Patil Deemed to be University  Approved 
IEC, School of Ayurveda, D. Y. Patil deemed to be University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy police personnel at risk of COVID - 19  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  AOIM - Z Tablets  One tablet twice a day for 90 days 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Healthy, Male or Female participants between the age group of 21 to years to 55 years (both inclusive).
Healthy police personnel will be considered as those who do not have any acute medical condition or chronic medical/surgical condition that requires either immediate or continuous medical monitoring and treatment.
2. Participants who are ready to provide written informed consent and who are ready to voluntarily participate and abide to the protocol requirements
 
 
ExclusionCriteria 
Details  1. Pregnant and Lactating females
2. Participants who have been quarantined or confirmed of having COVID-19 and have been isolated for its treatment. Participants having recently suffered and recovered of COVID-19 will also be excluded from the study
3. Participants having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening
4. Participants having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc.
5. Participants taking steroid treatment and or any kind of immunosuppressive therapy
6. Participants participating in any other clinical study or having participated in any other study 3 months prior to screening in the present study.
7. Other conditions, which in the opinion of the investigators makes the subject unsuitable for enrolment or could interfere in adherence to of the study protocol
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Prevention of Incidence of COVID – 19 infection in study participants  6 weeks(45 days) and 12 weeks (90 days) 
 
Secondary Outcome  
Outcome  TimePoints 
a) Comparative assessment of severity of COVID-19 (if it occurs) in study participants
b) Comparative assessment of incidence and severity of allergic conditions (non-infective) leading to sneezing, running nose, sore throat etc.
c) Comparative assessment of changes in Quality of life and overall health
d) Safety assessment by incidence of any adverse events in study participants
 
90 Days 
 
Target Sample Size   Total Sample Size="275"
Sample Size from India="275" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/06/2020 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
NIL 
Brief Summary
Modification(s)  

This study is for assessing the clinical efficacy of AOIM – Z Tablets for prevention of COVID – 19 pandemics in high risk healthy police personnel. The study will have total 275 healthy police personnel who have high risk of developing COVID-19 due to their job profile.

The consenting individuals will be screened as per inclusion and exclusion criteria of this study. The selected participants will take Tab. AOIM-Z ,1 tablet every morning and evening with water or lukewarm water for 90 days. The study drug i.e. Tab. AOIM- Z is an Ayurvedic medicine, marketed since many years and has been proven as immunomodulator by animal studies. The follow up will be taken at day 45±5 and day 90± days online. A questionnaire has been prepared specifically for this study. The participants will receive this questionnaire through email and WhatsApp. Assessment of health for symptoms of COVID 19, assessment of perception of quality of life, and overall health  will be covered through this questionnaire. The time required to fill the questionnaire may vary from ten to fifteen minutes.

 

Close