An interventional study to access the effect of Homoeopathic medicine in positive cases of COVID-19.

Phase 3

Not yet recruiting

• Conditions: Coronavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2020/07/026757
• Lead Sponsor: Ministry of AYUSH

Brief Summary

This study is a prospective double blind randomized placebo controlled interventional trial to assess the effectiveness of Eupatorium perfoliatum 30 C, 2 or 4 globules (child/adult dose respectively) twice daily for five days as an add on therapy in 200 participants of asymptomatic and mild symptomatic cases of COVID-19 in one centre in India. The primary outcome will assess the effectiveness of Eupatorium perfoliatum 30 C in preventing the progression of severity of the disease in SARS -CoV 2 tested positive asymptomatic and mild cases of COVID-19 and the secondary outcome will assess the changes in Quality of Life (QoL)  of the participants taking the medicine Eupatorium perfoliatum 30 C.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-07-22
• Study Start: 2020-07-31

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Subjects testing positive for SARS CoV-2 by RT-PCR, presenting with no symptoms or mild symptoms.
• Subjects 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

• Cases of COVID-19 with clinical severity ranging from moderate to critical.
• Pregnant and lactating females.
• Subjects having uncontrolled and unstable co morbidity.
• Immunocompromised subjects or those taking any kind of immunosupressive therapy.
• COVIC-19 positive cases participating as subjects in other COVID-19 clinical trails.
• Subjects having past history of allergy to any medicine that is part of the Homoeopathic intervention.
• Other conditions, which in the opinion of the investigator, makes the patient unsuitable for enrollment 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 the effectiveness of Homoeopathic medicine Eupatorium perfoliatum 30 C in preventing the progression of severity of the disease in the SARS-Cov-2 tested positive asymptomatic and mild cases of COVID-19.	3 month

Secondary Outcome Measures

Name	Time	Method
1. To assess the changes in Quality of Life (QoL) of the subjects using WHO QOL-BREF scale.	2. To assess the safety of Eupatorium perfoliatum 30 C drug by observing for adverse events.

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