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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000040602
Receipt No. 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 2022/03/13

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Basic information
Public title Homeopathy for Covid-19 in primary care
Acronym Covid-Simile Study
Scientific Title Homeopathy for Covid-19 in primary care: randomized, parallel-group, double-blind, placebo-controlled, clinical trial
Scientific Title:Acronym Homeopathy for Covid-19 in primary care: randomized, parallel-group, double-blind, placebo-controlled, clinical trial
(Covid-Simile study)
Region
South America

Condition
Condition Mild cases of Covid-19
Classification by specialty
Medicine in general Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effectiveness and safety of homeopathic medicine Natrum muriaticum (LM2) for mild cases of Covid-19 in primary care
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes 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.
Key secondary outcomes 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.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2 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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria Severe acute respiratory syndrome
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Ubiratan
Middle name Cardinalli
Last name Adler
Organization Sao Carlos Federal University
Division name Medicine Department
Zip code 13565-905
Address Rodovia Washington Luiz, Km 235, Sao Carlos, SP, Brazil
TEL 00551633519420
Email ubiratanadler@ufscar.br

Public contact
Name of contact person
1st name Ubiratan
Middle name Cardinalli
Last name Adler
Organization Sao Carlos Federal University
Division name Medicine Department
Zip code 13565-905
Address Rodovia Washington Luiz, Km 235, Sao Carlos, SP, Brazil
TEL 00551633519420
Homepage URL http://www.dmed.ufscar.br/
Email ubiratanadler@ufscar.br

Sponsor
Institute Sao Carlos Federal University - School Health Unit (USE)
Institute
Department

Funding Source
Organization Sao Carlos Federal University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Brazilian

Other related organizations
Co-sponsor HN-Cristiano Homeopathic Pharmacy - Sao Paulo - Brazil
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Research Ethics Commission
Address SRTVN 701, Via W 5 Norte, lote D - Ed. PO 700, 3o andar - Brasilia - Brazil - 70.719-040
Tel 00556133155877
Email conep@saude.gov.br

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions Vila Isabel Basic Health Unity - Sao Carlos - SP - Brazil (main unity)

Other administrative information
Date of disclosure of the study information
2020 Year 06 Month 01 Day

Related information
URL releasing protocol https://pubmed.ncbi.nlm.nih.gov/33522951/
Publication of results Published

Result
URL related to results and publications https://doi.org/10.1016/j.joim.2022.03.003
Number of participants that the trial has enrolled 100
Results 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.

Results date posted
2022 Year 03 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2022 Year 03 Month 12 Day
Baseline Characteristics
Participant flow
Adverse events 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.
Outcome measures 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).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2020 Year 05 Month 21 Day
Date of IRB
2020 Year 05 Month 30 Day
Anticipated trial start date
2020 Year 06 Month 15 Day
Last follow-up date
2021 Year 04 Month 14 Day
Date of closure to data entry
2021 Year 04 Month 21 Day
Date trial data considered complete
2021 Year 05 Month 04 Day
Date analysis concluded
2021 Year 06 Month 07 Day

Other
Other related information

Management information
Registered date
2020 Year 06 Month 01 Day
Last modified on
2022 Year 03 Month 13 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046338

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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