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Homeopathy for Covid-19 in Primary Care: A structured summary of a study protocol for a randomized controlled trial.
Adler, Ubiratan Cardinalli; Adler, Maristela Schiabel; Hotta, Livia Mitchiguian; Padula, Ana Elisa Madureira; de Toledo Cesar, Amarilys; Diniz, José Nelson Martins; Mestre, Crislaine Aparecida Antonio; Spiller, Katia Regina; Soares, Lidiamara; de Freitas Santos, Helen; Martinez, Edson Zangiacomi.
  • Adler UC; Medicine Department, Universidade Federal de São Carlos, Rodovia Washington Luiz, Km 235, São Carlos, SP, Brasil, 13565-905. ubiratanadler@ufscar.br.
  • Adler MS; Medicine Department, Universidade Federal de São Carlos, Rodovia Washington Luiz, Km 235, São Carlos, SP, Brasil, 13565-905.
  • Hotta LM; Centro Municipal de Práticas Integrativas e Complementares em Saúde CEMPICS, Rua Joaquim Miranda, 471, Guarulhos, SP, 07023-051, Brasil.
  • Padula AEM; Universidade Presbiteriana Mackenzie, R. Piauí, 181, São Paulo, SP, 01241-001, Brasil.
  • de Toledo Cesar A; Instituto HN-Cristiano, Rua Dr. Cesar 212, São Paulo, SP, 02013-001, Brasil.
  • Diniz JNM; Universidade Federal de São Carlos, School Health Unit (USE), Rodovia Washington Luiz, Km 235, São Carlos, SP, Brasil, 13565-905.
  • Mestre CAA; São Carlos' Health Surveillance, R. Conde do Pinhal, 2161 -, São Carlos, SP, 13560-648, Brasil.
  • Spiller KR; São Carlos' Epidemiological Surveillance, R. Conde do Pinhal, 2161, São Carlos, SP, 13560-648, Brasil.
  • Soares L; São Carlos' Epidemiological Surveillance, R. Conde do Pinhal, 2161, São Carlos, SP, 13560-648, Brasil.
  • de Freitas Santos H; Instituto Federal de Educação Ciência e Tecnologia de São Paulo, R. Pedro Cavalo, 709, Birigui, SP, 16201-407, Brasil.
  • Martinez EZ; Social Medicine Department, Universidade de São Paulo - Faculdade de Medicina de Ribeirão Preto, Av. Bandeirantes, 3900, Ribeirão Preto, SP, Brasil, 14049-900.
Trials ; 22(1): 109, 2021 Feb 01.
Article in English | MEDLINE | ID: covidwho-1058267
Semantic information from SemMedBD (by NLM)
1. Homeopathy TREATS COVID-19
Subject
Homeopathy
Predicate
TREATS
Object
COVID-19
2. Homeopathy COEXISTS_WITH Primary Health Care
Subject
Homeopathy
Predicate
COEXISTS_WITH
Object
Primary Health Care
3. Placebos COEXISTS_WITH Primary Health Care
Subject
Placebos
Predicate
COEXISTS_WITH
Object
Primary Health Care
4. University Medical Information Network LOCATION_OF Study
Subject
University Medical Information Network
Predicate
LOCATION_OF
Object
Study
5. Homeopathy TREATS COVID-19
Subject
Homeopathy
Predicate
TREATS
Object
COVID-19
6. Homeopathy COEXISTS_WITH Primary Health Care
Subject
Homeopathy
Predicate
COEXISTS_WITH
Object
Primary Health Care
7. Placebos COEXISTS_WITH Primary Health Care
Subject
Placebos
Predicate
COEXISTS_WITH
Object
Primary Health Care
8. University Medical Information Network LOCATION_OF Study
Subject
University Medical Information Network
Predicate
LOCATION_OF
Object
Study
ABSTRACT

OBJECTIVES:

To investigate the effectiveness and safety of homeopathic medicine Natrum muriaticum (LM2) for mild cases of COVID-19 in Primary Health Care. TRIAL

DESIGN:

A randomized, two-armed (11), parallel, placebo-controlled, double-blind, clinical trial is being performed to test the following hypotheses H0 homeopathic medicines = placebo (null hypothesis) vs. H1 homeopathic medicines ≠ placebo (alternative hypothesis) for mild cases of COVID-19 in Primary Care.

PARTICIPANTS:

Setting:

Primary Care of São Carlos - São Paulo - Brazil. One hundred participants aged 18 years or older, with Influenza-like symptoms and a positive RT-PCR for SARS-CoV-2. Willingness to give informed consent and to comply with the study procedures is also required. Exclusion criterium severe acute respiratory syndrome. INTERVENTION AND COMPARATOR Homeopathy 1 globule of Natrum muriaticum LM2 diluted in 20 mL of alcohol 30% and dispensed in a 30 ml bottle. Placebo 20 mL of alcohol 30% dispensed in a 30 ml bottle. Posology one drop 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 (succussions) before each dose. Posology may be changed by telemedicine, with no break in blinding. Study medication should be maintained during home isolation. According to the Primary Care protocol, the home isolation period lasts until the 10th day after the appearance of the first symptom, or up to 72 hours without symptoms. MAIN

OUTCOMES:

The primary endpoint will be time to recovery, defined as the number of days elapsed before all COVID-19 Influenza-like symptoms are recorded as mild or absent during home isolation period. Secondary measures are recovery time for each COVID-19 symptom; score of the scale created for the study (COVID-Simile Scale); medicines used during follow-up; number of days of follow-up; number of visits to emergency services; number of hospitalizations; other symptoms and Adverse Events during home isolation period. RANDOMISATION The study Statistician generated a block randomization list, using a 11 ratio of the two groups (denoted as A and B) and a web-based tool ( http//www.random.org/lists ). BLINDING (MASKING) The clinical investigators, the statistician, the Primary Care teams, the study collaborators, and the participants will remain blinded from the identity of the two treatment groups until the end of the study. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) One hundred participants are planned to be randomized (11) to placebo (50) or homeopathy (50). TRIAL STATUS Protocol version/date May 21, 2020. Recruitment is ongoing. First participant was recruited/included on June 29,2020. Due to recruitment adaptations to Primary Care changes, the authors anticipate the trial will finish recruiting on April 10, 2021. TRIAL REGISTRATION COVID-Simile Study was registered at the University Hospital Medical Information Network (UMIN - https//www.umin.ac.jp/ctr/index.htm ) on June 1st, 2020, and the trial start date was June 15, 2020. Unique ID UMIN000040602. FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: Primary Health Care / Materia Medica / Sodium Chloride, Dietary / SARS-CoV-2 / COVID-19 / Homeopathy Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged / Young adult Country/Region as subject: South America / Brazil Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Primary Health Care / Materia Medica / Sodium Chloride, Dietary / SARS-CoV-2 / COVID-19 / Homeopathy Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged / Young adult Country/Region as subject: South America / Brazil Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2021 Document Type: Article