Preventive trial of Homoeopathic medicines in COVID-19

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2020/11/029265
• Date of registration: 20-11-2020
• Prospective Registration: Yes
• Primary sponsor: Ministry of AYUSH Govt of India
• Public title: Preventive trial of Homoeopathic medicines in COVID-19
• Scientific title: Prophylactic effects of homoeopathic medicines in Kolkata during COVID-19 pandemic: A community-based, randomized trial
• Date of first enrolment: 30-11-2020
• Target sample size: 20000
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48401
• 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: Prof Dr Subhasish Ganguly
• Affiliation: D N De Homoeopathic Medical College and Hospital, Govt. of West Bengal

• Name: Prof Dr Satadal Das
• Affiliation: D N De Homoeopathic Medical College and Hospital, Govt. of West Bengal

Key inclusion & exclusion criteria

Inclusion criteria: a) Persons residing in the Tangra area of Kolkata

b) Age between 1 yr and 75 yrs

c) Participants of either sex

d) Written consent to participate (guardianâ??s consent in cases of minors)
Exclusion criteria: a) Diagnosed or suspected cases of COVID-19

b) Currently suffering from flu-like illnesses

c) People who have already taken homoeoprophylaxis in some forms within last 30 days

d) Cases with vital organ failure

e) Immune compromised state

Age minimum:
Age maximum:
Gender:

Intervention(s)

Intervention1: Bryonia alba 30CH; 6 doses once daily for 6 days (for adults) or 3 doses for 3 days (for infants/children); plus ascorbic acid tablets of 500 mg per day for 6 days for participants aged 5-75 years: Bryonia alba 30CH (preserved in 90% v/v ethanol); 3 (for children) or 6 (for adults) doses once daily in morning for 3 or 6 days. Each dose shall consist of either 2 (for infants/children) or 4 (for adults) medicated globules (no. 30) of cane sugar, to be taken orally on clean tongue with empty stomach. Participants will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. All medicines and sundry items have been procured from Hahnemann Publishing Company - a Good Manufacturing Practice (GMP)-certified firm. Along with this, ascorbic acid tablets of 500 mg (Dusap Pharmaceuticals) per day for 6 days for participants aged 5-75 years will be advised once per day for 6 days. A minimum of one hour interval should be kept between the intake of homoeopathic medicine and ascorbic acid tablets. Along with that, general hygienic measures like hand washing, maintaining social distancing, proper use of mask, gloves etc. and healthy dietary advices will be given to all participants. Route of administration: Oral. Duration of therapy: 3 (for children) or 6 (for adults) days.
Intervention2: Gelsemium sempervirens 30CH; 6 doses once daily for 6 days (for adults) or 3 doses for 3 days (for infants/children); plus ascorbic acid tablets of 500 mg per day for 6 days for participants aged 5-75 years: Gelsemium sempervirens 30CH (preserved in 90% v/v ethanol); 3 (for children) or 6 (for adults) doses once daily in mornin

Primary Outcome(s)

Occurrence of newly diagnosed (laboratory confirmed by PCR) COVID-19 infection rates across the groupsTimepoint: Up to 30 days after completing the recommended dosage or once the person reports COVID-19 positive by PCR tests, whichever is earlier

Secondary Outcome(s)

Occurrence of flu-like illnesses and/or clinically suspected cases of COVID-19 infections across the groupsTimepoint: Up to 30 days after completing the recommended dosage or once the person reports COVID-19 positive by PCR tests, whichever is earlier

Secondary ID(s)

U1111-1259-4250

Source(s) of Monetary Support

EMR section, Ministry of AYUSH, Govt. of India, Plate-A, 2nd floor, Office Block III, NBCC Complex, East Kidwai Nagar, New Delhi 110023

Secondary Sponsor(s)

D N De Homoeopathic Medical College and Hospital Govt of West Bengal

Ethics review

Status: Approved
Approval date: 28/04/2020
Contact:

Institutional Ethical Committee

Results

• Date Completed: 19/01/2021