Using Silica 12CH to Mitigate the Effects and Symptoms of Silicosis in Brazil
NCT ID: NCT06011785
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
EARLY_PHASE1
100 participants
INTERVENTIONAL
2024-03-01
2026-03-01
Brief Summary
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Detailed Description
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The study design is a controlled non-blinded clinical study without randomization to test the effectiveness of a homeopathic intervention among individuals with symptoms of Silicosis as a result of working as quartzite miners. The intervention to be studied is a homeopathic preparation of Silica 12CH on a sample of clients with Silicosis already receiving ongoing conventional medical care. The intervention is Silica 12CH given over one year: a single dose at intervals of three months (three times in the study period).
Participants will be recruited locally through the clinic where they already receive ongoing medical attention. The local secretary of health authorizes the release of the patient files. Potential participants will be given printed information about the study details along with information about how to participate and the associated deadlines for joining the study. Interested individuals will be given the informed consent form.
Participants will freely elect to be in either the control or intervention group. Individuals in the control group follow the standard-care protocol without the homeopathic intervention. Individuals in the experimental group will receive the homeopathic intervention while also following the standard-care protocol. All individuals will be encouraged to continue with any concurrent conventional medical treatment for their Silicosis-related symptoms. Individuals in either group may freely leave the study at any time with no consequence. Additionally, participants may freely elect to be moved from the control group into the experimental group at the half-way point in the study.
Conditions
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Study Design
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NA
SINGLE_GROUP
Participants will be recruited locally through the clinic where they already receive ongoing medical attention. The local secretary of health authorizes the release of the patient files. Potential participants will be given printed information about the study details along with information about how to participate and the associated deadlines for joining the study. Interested individuals will be given the informed consent form.
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention Group
Participants have Silicosis and wish to be included in the intervention group
Silica 12CH
Participants will freely elect to be in either the intervention group. Individuals in the experimental group will receive the intervention while also following the standard-care protocol. All individuals will be encouraged to continue with any concurrent conventional medical treatment for their Silicosis-related symptoms. Individuals in either group may freely leave the study at any time with no consequence. Additionally, participants may freely elect to decide opt out at any time.
Interventions
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Silica 12CH
Participants will freely elect to be in either the intervention group. Individuals in the experimental group will receive the intervention while also following the standard-care protocol. All individuals will be encouraged to continue with any concurrent conventional medical treatment for their Silicosis-related symptoms. Individuals in either group may freely leave the study at any time with no consequence. Additionally, participants may freely elect to decide opt out at any time.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* must be at least 18 years old
* must have a clinical diagnosis of silicosis
* must be receiving conventional medical care and/or monitoring for their condition
Exclusion Criteria
* individuals who are not receiving conventional medical care and/or monitoring for their condition
* individuals too infirm to receive regular monitoring as required for the study
* Interested participants without Silicosis
* Individuals with Tuberculosis
* Individuals defined as part of a vulnerable group
* legal or clinically incapable persons
* person in a state of temporary disability;
* of a member of indigenous community
18 Years
65 Years
ALL
No
Sponsors
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HOHM Foundation
OTHER
Responsible Party
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Alastair Gray
Director Research
Principal Investigators
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Alastair C Gray, PhD
Role: PRINCIPAL_INVESTIGATOR
HOHM Foundation
Locations
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HOHM Foundation
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Souza TP, Watte G, Gusso AM, Souza R, Moreira JDS, Knorst MM. Silicosis prevalence and risk factors in semi-precious stone mining in Brazil. Am J Ind Med. 2017 Jun;60(6):529-536. doi: 10.1002/ajim.22719.
Souza TP, van Tongeren M, Monteiro I. Respiratory health and silicosis in artisanal mine workers in southern Brazil. Am J Ind Med. 2021 Jun;64(6):511-518. doi: 10.1002/ajim.23242. Epub 2021 Mar 28.
Carneiro AP, Braz NF, Algranti E, Bezerra OM, Araujo NP, Amaral Eng Hyg LS, Edme JL, Sobaszek A, Cherot-Kornobis N. Silica exposure and disease in semi-precious stone craftsmen, Minas Gerais, Brazil. Am J Ind Med. 2017 Mar;60(3):239-247. doi: 10.1002/ajim.22682.
Goyal KK. Two cases of pulmonary TB treated with homeopathy. Homeopathy. 2002 Jan;91(1):43-6. doi: 10.1054/homp.2001.0009. No abstract available.
Chand KS, Manchanda RK, Mittal R, Batra S, Banavaliker JN, De I. Homeopathic treatment in addition to standard care in multi drug resistant pulmonary tuberculosis: a randomized, double blind, placebo controlled clinical trial. Homeopathy. 2014 Apr;103(2):97-107. doi: 10.1016/j.homp.2013.12.003.
Hoeper MM, Welte T. Systemic inflammation, COPD, and pulmonary hypertension. Chest. 2007 Feb;131(2):634-5; author reply 635. doi: 10.1378/chest.06-2207. No abstract available.
Boccolini PMM, de Lima Sirio Boclin K, de Sousa IMC, Boccolini CS. Prevalence of complementary and alternative medicine use in Brazil: results of the National Health Survey, 2019. BMC Complement Med Ther. 2022 Aug 2;22(1):205. doi: 10.1186/s12906-022-03687-x.
Other Identifiers
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HOHMF
Identifier Type: -
Identifier Source: org_study_id
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