Homoeopathy in the prevention of COVID-19

• Register: CTRI
• Last refreshed on: 4 March 2024
• Main ID: CTRI/2020/09/028122
• Date of registration: 29-09-2020
• Prospective Registration: Yes
• Primary sponsor: Ministry of AYUSH Govt of India
• Public title: Homoeopathy in the prevention of COVID-19
• Scientific title: Homoeopathic medicines in the prevention of COVID-19 among high risk individuals: A community based, double-blind randomized controlled trial
• Date of first enrolment: 06-10-2020
• Target sample size: 15992
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47851
• Study type: Interventional
• Study design: Randomized, Parallel Group, Multiple Arm Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: Shubhamoy Ghosh
• Affiliation: Mahesh Bhattacharyya Homoeopathic Medical College and Hospital

• Name: Shubhamoy Ghosh
• Affiliation: Mahesh Bhattacharyya Homoeopathic Medical College and Hospital

Key inclusion & exclusion criteria

Inclusion criteria: a)Persons residing in the ward no. 27 under Howrah Municipal Corporation.

d)Person giving consent to participate (guardian’s consent in cases of minors)


Exclusion criteria: a)Diagnosed cases of COVID-19 or persons with related symptoms

b)People who have already taken homoeopathic medicines in some forms within the last 15 days

c)Cases with vital organ failure

d)Immune compromised state



Age minimum:
Age maximum:
Gender:

Intervention(s)

Intervention1: Arsenicum album 30: Two doses of medicated globules (no. 10) will be given as single dose once in a week for two weeks. The cane sugar globules will be medicated with the medicine (preserved in 90% v/v ethanol) to be taken orally on clean tongue with empty stomach.; Route of administration: Oral; Duration of therapy: 2 weeks
Intervention2: Oscillococcinum® (Anas barbariae hepatis et cordis extractum 200K): Two doses of medicated globules (no. 10) will be given as single dose once in a week for two weeks. The medicine will be obtained as provided by the concerned manufacturer. Each dose to be taken orally on clean tongue with empty stomach.; Route of administration: Oral; Duration of therapy: 2 weeks
Intervention3: Influenzinum 30: Two doses of medicated globules (no. 10) will be given as single dose once in a week for two weeks. The cane sugar globules will be medicated with the medicine (preserved in 90% v/v ethanol) to be taken orally on clean tongue with empty stomach.; Route of administration: Oral; Duration of therapy: 2 weeks
Control Intervention1: Placebo: This arm, will receive placebo, indistinguishable from verum. Each dose shall consist of 4 globules (no.10) for children aged up to 12 years and 8 globules (no. 10) for person aged 13 years or above. The globules will be moistened with 90% v/v ethanol to be taken orally on clean tongue with empty stomach, once daily for subsequent 6 days. Duration of intervention will be 6 days, followed by follow up period of 24 days.
Control Intervention2: Placebo: This arm, will receive placebo, indistinguishable from verum. Dose and Frequency: Each dose shall consist of globules no. 10, moistened with 90% v/v ethanol. Each dose to be taken orally on clean tongue in empty stomach, once in a week for consecutiv

Primary Outcome(s)

Occurrence of newly diagnosed (laboratory confirmed) COVID-19 infection rates across the groupsTimepoint: After 30 days of first medicine intake or once the person reports the tests positive for the same.

Secondary Outcome(s)

Occurrence of flu like illness and/or clinically suspected cases of COVID-19 infection across the groups.Timepoint: At any time points within 30 days of follow-up

Secondary ID(s)

NIL

Source(s) of Monetary Support

EMR Section, Ministry of AYUSH, Govt of India Address: Plate-A, 2nd Floor, Office Block-III, NBCC Complex, East Kidwai Nagar, New Delhi-23

Secondary Sponsor(s)

Mahesh Bhattacharyya Homoeopathic Medical College Hospital

Ethics review

Status: Approved
Approval date: 27/06/2020
Contact:

IEC of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital

Results

• Date Completed: 28/02/2024