Preventive trial of Homoeopathic medicines in COVID-19

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2020
INTERVENTION: 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 CONDITION: PRIMARY OUTCOME: 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: 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 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)
Epistemonikos ID: af3b6ba4d866316c6b397101252563f1d766d93c
First added on: Dec 05, 2020