Silicosis
Conditions
Brief summary
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
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.
Interventions
DRUGSilica 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.
Sponsors
HOHM Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
No masking required.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | One year | Monitor changes using validated wellness measurement instrument |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | One year | Monitor changes using validated wellness measurement instrument |
Countries
United States
Contacts
Primary ContactAlastair C Gray, PhD
Backup ContactParker Pracjek, MA
Outcome results
None listed