CTRI Number	CTRI/2020/05/025222 [Registered on: 18/05/2020] Trial Registered Prospectively
Last Modified On:	24/06/2021
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Drug Ayurveda
Study Design	Single Arm Study
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)	Other (Terminated)
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.