Unique ID issued by UMIN | UMIN000040602 |
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Receipt number | R000046338 |
Scientific Title | Homeopathy for Covid-19 in primary care: randomized, parallel-group, double-blind, placebo-controlled, clinical trial |
Date of disclosure of the study information | 2020/06/01 |
Last modified on | 2023/05/20 05:50:57 |
Homeopathy for Covid-19 in primary care
Covid-Simile Study
Homeopathy for Covid-19 in primary care: randomized, parallel-group, double-blind, placebo-controlled, clinical trial
Homeopathy for Covid-19 in primary care: randomized, parallel-group, double-blind, placebo-controlled, clinical trial
(Covid-Simile study)
South America |
Mild cases of Covid-19
Medicine in general | Infectious disease |
Others
NO
To investigate the effectiveness and safety of homeopathic medicine Natrum muriaticum (LM2) for mild cases of Covid-19 in primary care
Safety,Efficacy
Exploratory
Explanatory
Phase II
time to recovery, defined as the number of days elapsed before all the most common Covid-19 flu-like symptoms are recorded as mild or absent.
recovery time for each of the Covid-19 symptoms; score of the scale created for the study (Covid-Simile scale); medicines used during the 14 days of study participation; number of visits to emergency services; number of hospitalizations; other symptoms and Adverse Events.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is considered as a block.
NO
Central registration
2
Treatment
Medicine |
One drop of a (30% hydroalcoholic) solution of Natrum muriaticum LM2 taken orally every 4 hours (6 doses/day) while there is fever, cough, tiredness or pain (headache, sore throat, muscle aches, chest pain etc.) followed by one drop every 6 hours (4 doses/day) until the fourteenth day of use.The bottle of study medication should be submitted to 10 vigorous shakes (sucussions) before each dose.
One drop of a placebo (30% hydroalcoholic) solution taken orally every 4 hours (6 doses/day) while there is fever, cough, tiredness or pain (headache, sore throat, muscle aches, chest pain etc.) followed by one drop every 6 hours (4 doses/day) until the fourteenth day of use.The bottle of study medication should be submitted to 10 vigorous shakes (sucussions) before each dose.
18 | years-old | <= |
Not applicable |
Male and Female
Flu-like syndrome and a positive RT-PCR for SARS-CoV-2. Willingness to give informed consent and to comply with the study procedures will also be required.
Severe acute respiratory syndrome
100
1st name | Ubiratan |
Middle name | Cardinalli |
Last name | Adler |
Sao Carlos Federal University
Medicine Department
13565-905
Rodovia Washington Luiz, Km 235, Sao Carlos, SP, Brazil
00551633519420
ubiratanadler@ufscar.br
1st name | Ubiratan |
Middle name | Cardinalli |
Last name | Adler |
Sao Carlos Federal University
Medicine Department
13565-905
Rodovia Washington Luiz, Km 235, Sao Carlos, SP, Brazil
00551633519420
http://www.dmed.ufscar.br/
ubiratanadler@ufscar.br
Sao Carlos Federal University - School Health Unit (USE)
Sao Carlos Federal University
Self funding
Brazilian
HN-Cristiano Homeopathic Pharmacy - Sao Paulo - Brazil
National Research Ethics Commission
SRTVN 701, Via W 5 Norte, lote D - Ed. PO 700, 3o andar - Brasilia - Brazil - 70.719-040
00556133155877
conep@saude.gov.br
NO
Vila Isabel Basic Health Unity - Sao Carlos - SP - Brazil (main unity)
2020 | Year | 06 | Month | 01 | Day |
https://pubmed.ncbi.nlm.nih.gov/33522951/
Published
https://doi.org/10.1016/j.joim.2022.03.003
100
Results showed that Natrum muriaticum LM2 was safe to use for COVID-19, but there was no statistically significant difference in the primary endpoints of Natrum muriaticum LM2 and placebo for mild COVID-19 cases. Although some secondary measures do not support the null hypothesis, the wide confidence intervals suggest that further studies with larger sample sizes and more symptomatic participants are needed to test the effectiveness of homeopathic Natrum muriaticum LM2 for COVID-19.
2022 | Year | 03 | Month | 13 | Day |
2022 | Year | 03 | Month | 12 | Day |
Hospitalization rates were 2.4% in the homeopathy group and 6.8% in the placebo group (P = 0.62). Participants reported 3 adverse events in the homeopathy group and 6 in the placebo group.
Data from 86 participants were analyzed (homeopathy, n = 42; placebo, n = 44). There was no difference in time to recovery between two groups among participants who were reporting influenza-like symptoms at the beginning of monitoring (homeopathy, n = 41; placebo, n = 41; P = 0.56), nor in a sub-group that had at least five moderate to severe influenza-like symptoms at the beginning of monitoring (homeopathy, n = 15; placebo, n = 17; P = 0.06). Secondary outcomes indicated that a 50% reduction in symptom score was achieved significantly earlier in the homeopathy group (homeopathy, n = 24; placebo, n = 25; P = 0.04) among the participants with a basal symptom score greater than or equal to 5. Moreover, values of restricted mean survival time indicated that patients receiving homeopathy might have improved 0.9 days faster during the first five days of follow-up (P = 0.022).
Main results already published
2020 | Year | 05 | Month | 21 | Day |
2020 | Year | 05 | Month | 30 | Day |
2020 | Year | 06 | Month | 15 | Day |
2021 | Year | 04 | Month | 14 | Day |
2021 | Year | 04 | Month | 21 | Day |
2021 | Year | 05 | Month | 04 | Day |
2021 | Year | 06 | Month | 07 | Day |
Adler UC, Adler MS, Padula AEM, et al. Homeopathy for COVID-19 in primary care: A randomized, double-blind, placebo-controlled trial (COVID-Simile study). J Integr Med. 2022;20(3):221-229. doi:10.1016/j.joim.2022.03.003
2020 | Year | 06 | Month | 01 | Day |
2023 | Year | 05 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046338
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