UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040602
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

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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 or person

Institute

Sao Carlos Federal University - School Health Unit (USE)

Institute

Department

Personal name



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

Main results already published

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

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


Management information

Registered date

2020 Year 06 Month 01 Day

Last modified on

2023 Year 05 Month 20 Day



Link to view the page

Value
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