Using Silica 12CH to Mitigate the Effects and Symptoms of Silicosis in Brazil

Study Overview
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Brief Summary
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This clinical study aims to address a research and clinical treatment gap related to individuals with symptoms of Silicosis resulting from quartzite mining work. Silicosis represents a challenge in this specific population in Sao Thome das Letras, Minas Gerais. Silicosis is a severe disease and is considered incurable. Current conventional medicine only offers palliative care for those with Silicosis, highlighting the important and urgent need for research into complementary care approaches.

Detailed Description
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The study design is a simple clinical trial to assess the effect of the homeopathic medication Silica 12CH given alongside the conventional treatment of Silicosis, versus standard treatment alone for Silicosis. 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.

Official Title
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Using Silica 12CH to Mitigate the Effects and Symptoms of Silicosis in Brazil

Conditions
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Silicosis

Intervention / Treatment
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* Drug: Silica 12CH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be eligible to participate, participants must meet the following 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 under the age of 18 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: The study design is a controlled non-blinded clinical study without randomization to test the effectiveness of an 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Participants have Silicosis and wish to be included in the intervention group | Drug: Silica 12CH<br>* 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.<br>* Other names: Silicea terra (sil);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pulmonary health of individuals with Silicosis as assessed by symptoms '1' and '2' using the Measure Yourself Concerns and Wellbeing (MYCaW validated) wellness measurement instrument. 0 = As good as it can be. 6 = As bad as it can be | Monitor changes using validated wellness measurement instrument | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pulmonary health of individuals with Silicosis as assessed by overall wellness scores using the Measure Yourself Concerns and Wellbeing (MYCaW validated) wellness measurement instrument. 0 = As good as it can be. 6 = As bad as it can be. | Monitor changes using validated wellness measurement instrument | One year |