An interventional study to access the effect of Homoeopathic medicine Arsenicum album 30 C as a prohylaxis in high risk population exposed to COVID-19.

Phase 3

Not yet recruiting

• Conditions: High Risk Population exposed to COVID-19

• Registration Number: CTRI/2020/06/026056
• Lead Sponsor: Ministry of AYUSH

Brief Summary

This study is a prospective non-randomized interventional trial to assess the effectiveness of Arsenicum album 30 C, 3 or 5 globules (child/adult dose respectively) once daily for three days as a prophylactic measure in 5000 participants of the high-risk population exposed to COVID-19 in one centre in India. The primary outcome will measure the assessment of the occurrence of COVID-19 infection in healthy volunteers and the secondary outcome will assess the immunity status of the participants taking the medicine Arsenicum album 30C.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-06-23
• Study Start: 2020-06-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Subjects of high risk population.
• Male or female subjects above the age of 03 years to 65 years.
• Subject who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study.

Exclusion Criteria

• Pregnant and Lactating woman.
• Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening.
• Subjects who are on any other regular medication( Alternative/ Modern)for any other ailments.
• Subjects participating in any other clinical study or having participated in any other study one month prior to screening in the present study.
• Subjects having a past history of allergy to any medicine that is part of the Homoeopathic intervention.
• Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess of occurrence of COVID-19 infection in healthy volunteers exposed to COVID-19 in the community	6 months

Secondary Outcome Measures

Name	Time	Method
1. To assess the immunity status of the participants taking Arsenicum album -30 C	2. To evaluate the occurance of advarse event for safety assessment of Arsenicum album-30C.

Trial Locations

Locations (1)

North Eastern Institute of Ayurveda and Homoeopathy; 🇮🇳 Hills, MEGHALAYA, India

North Eastern Institute of Ayurveda and Homoeopathy

🇮🇳Hills, MEGHALAYA, India

Prof Dr P K Goswami

Principal investigator

9415385128

pkgoswamibhu@gmail.com