Adverse effects of COVID VACCINES

Completed

• Conditions: Healthy human volunteers who have been vaccinated

• Registration Number: CTRI/2021/06/034208
• Lead Sponsor: YENEPOYA MEDICAL COLLEGE

Brief Summary

**TITLE OF THE RESEARCH PROPOSAL**:

**“**Assessmentand correlation of adverse drug reactions following COVID vaccination withblood group and dietary style -A pilot study.â€

**HYPOTHESIS/RESEARCH QUESTION**:

What are the percentages of different adverse eventsexperienced by the individuals? Whether AEFI are related to blood groups anddietary styles of an individual?

**OBJECTIVES OF THE STUDY**:

To assess differenttypes of adverse drug reactions following COVID vaccination and to correlatewith blood groups and dietary style.

**METHODOLOGY**

**Study design:** Questionnaire basedpilot study

**Materials and methods:** This is an online questionnaire(English version) based cross-sectional study. The validated questionnaire isprepared using Google forms. This questionnaire will be sent by mail/WhatsAppto all the students and Staffs of Yenepoya Medical College Hospital, Mangalore. The responses along with the demographicdata of the participants will be collected, analyzed and interpreted.

 Ethical clearance will be obtained from the Institutional EthicalCommittee before starting the study. Informed consent will be obtained (ingoogle form) from the participantsafter describing thepurpose of the study and the assurance to maintain the anonymity andconfidentiality

This is an online questionnaire (Englishversion) based cross-sectional study.

 **a)Study setting:** Yenepoya Medical College**,** Yenepoya deemed to be University, Mangalore,Dakshina Kannada.

**b)Study Population:** Health care professionals of various collegesof Yenepoya (Deemed to be University), Mangalore.

**c)  Studyperiod:** This study shall beconducted from 20th  April 2021 to 20th July 2021 (3months)

**Source of data/sampling method:**

| | | |

| --- | --- | --- |

|**Variables**

**Method of collection**

**Source**

|Age, Gender, Blood group & dietary style

Questionnaire form

Google survey

|Questions of adverse events, time duration etc

Questionnaire form

Google survey

**Sample size:** Due to lack of literature evidence tocalculate sample size, I would like to do time bond study. This will establishnew evidence for future studies.

a)      Samplingtechnique: Time bound sampling method will be followed in this study to collectthe data. The google link of questionnaire form on adverse events followingCOVID vaccine will be shared to students and health professionals via WhatsAppor email and requested them to give feedback and circulate the link to theirfriends/batch mates. Their friends/batch mates will be requested to circulatethe google link to their contacts. The procedure will be followed till weachieve required sample size.

b)      Samplesize: 100 (time bound)

c)      Randomization(if any): Not applicable

d)     Detailsof clinical examination (if any) NA

e)      Detailsof study like questionnaire (if any)- questionnaire attached

    f)       Validationof study tool (if applicable) – Validated by two professor

 g)      Detailsof investigations (if any) NA

**Inclusion criteria:**  Medical/dental/Alliedhealth undergraduates & postgraduate student and health care professionals ofVarious colleges affiliated to Yenepoya (Deemed to be University), Mangalore whoare vaccinated and willing to give their consent for this study will beincluded.

 **Details of data tabulation and statistical analysis to be employed:**

At the end of the study, Statistical analysis will be done using Simple descriptive statistics with appropriatemethod to describe the data. Regression analysis technique is used to assessthe adverse drug reactions after Covid-19 vaccination and correlate with bloodgroup and dietary factors.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-15
• Last Update Posted: 2022-05-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Medical/dental/Allied health undergraduates & postgraduate student and health care professionals of Various colleges affiliated to Yenepoya (Deemed to be University), Mangalore who are vaccinated and willing to give their consent for this study will be included.

Exclusion Criteria

Individuals who are not vaccinated and do not give consent for the study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
different types of adverse drug reactions following COVID vaccination and to correlate with blood groups and dietary style	DAY1 TO DAY 4

Trial Locations

Locations (1)

YENEPOYA MEDICAL COLLEGE; 🇮🇳 Kannada, KARNATAKA, India

YENEPOYA MEDICAL COLLEGE

🇮🇳Kannada, KARNATAKA, India

Dr Prabhakar Adake

Principal investigator

9886554800

dradake82@gmail.com