An Early Phase 1 interventional study of Silica 12CH in Silicosis, sponsored by HOHM Foundation. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by HOHM Foundation · Early Phase 1, Interventional, and Supportive care
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.
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.
20 studies on the registry are indexed under Silicosis; 3 are open to participants now.
Browse Silicosis studies →This is the only study on the registry with HOHM Foundation as lead sponsor.
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To be eligible to participate, participants must meet the following criteria:
Exclusion Criteria:
● Individuals under the age of 18
Individuals defined as part of a vulnerable group
Participants have Silicosis and wish to be included in the intervention group
Drug: 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.
Also known as: Silicea terra (sil)
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
Time frame: One year
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
Time frame: One year
Plan to share: No — Survey data will be collected and stored using Alchemer before being transferred to Excel. Only the Principal Investigators will have access to this data at the conclusion of the data collection portion of the study. This information will then be stored on a password protected secure file. It will not be printed or shared with anyone else for any purpose. The only research personnel who will have authority to use or have access to the information are the Principal (Alastair Gray) and Co-Investigator (Parker Pracjek).
Start is estimated for Mar 2024; primary completion for Mar 2025, 12 months later.
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This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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