Silica 12CH for Silicosis

(HOHM Trial)

Overseen By Parker Pracjek, MA

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: HOHM Foundation

Disqualifiers: Under 18, Tuberculosis, Vulnerable, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 12 months

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since participants must be receiving conventional medical care, it seems likely that you can continue your current treatment.

Is Silica 12CH safe for human use?

Hydrophobic silicas, similar to Silica 12CH, have shown no adverse health effects when handled properly, and tests in animals have not shown harmful effects. However, crystalline silica, a different form, is considered a carcinogen when inhaled, so it's important to distinguish between these forms. ^{1 2 3 4 5}

How does the treatment Silica 12CH differ from other treatments for silicosis?

Silica 12CH is a homeopathic preparation, which is unique because it uses highly diluted silica, unlike conventional treatments that focus on supportive care or lung transplantation. There are no specific effective treatments for silicosis, making this approach novel in its use of homeopathy for a condition traditionally managed by preventing exposure and providing supportive care. ^{6 7 8 9 10}

Research Team

Alastair C Gray, PhD

Principal Investigator

HOHM Foundation

Eligibility Criteria

This trial is for adults over 18 in Sao Thome das Letras, Brazil, who have been clinically diagnosed with Silicosis from quartzite mining and are under conventional medical care. It excludes those with Tuberculosis, not suffering from Silicosis, under legal incapacity or too infirm for regular monitoring.

Inclusion Criteria

I am currently under medical care for my condition.

I have been diagnosed with silicosis.

Exclusion Criteria

I am under 18 years old.

I am too unwell to attend regular study check-ups.

I have Tuberculosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive Silica 12CH alongside conventional treatment, with doses every three months over one year

12 months

3 visits (in-person)

Follow-up

Participants are monitored for changes in pulmonary health using the MYCaW wellness measurement instrument

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Silica 12CH

Trial Overview The study tests the use of a homeopathic remedy called Silica 12CH to alleviate symptoms of Silicosis—a severe lung disease without a cure—in miners. The aim is to explore complementary treatments alongside existing palliative care.

Participant Groups

Group I: Intervention Group Experimental Treatment 1 Intervention

Participants have Silicosis and wish to be included in the intervention group

Who Is Running the Clinical Trial?

HOHM Foundation

Lead Sponsor

Trials

1

Recruited

100+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Characterization and toxicological behavior of synthetic amorphous hydrophobic silica. [2005]

2. Finland pubmed.ncbi.nlm.nih.gov

Evaluation of crystalline silica as a threshold carcinogen. [2007]

3. England pubmed.ncbi.nlm.nih.gov

Exposure-response analysis and risk assessment for silica and silicosis mortality in a pooled analysis of six cohorts. [2019]

4. Finland pubmed.ncbi.nlm.nih.gov

Assessment of silicosis risk for occupational exposure to crystalline silica. [2005]

5. England pubmed.ncbi.nlm.nih.gov

Mortality in the UK industrial silica sand industry: 2. A retrospective cohort study. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of silica on human lung fibroblast in culture. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Silicosis-related years of potential life lost before age 65 years--United States, 1968-2005. [2009]

8. United States pubmed.ncbi.nlm.nih.gov

Low expression of lipoic acid synthase aggravates silica-induced pulmonary fibrosis by inhibiting the differentiation of Tregs in mice. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Interleukin-12 is not essential for silicosis in mice. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Silicosis mortality trends and new exposures to respirable crystalline silica - United States, 2001-2010. [2023]