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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for silicosis, a lung disease affecting those exposed to silica dust, such as quartzite miners. Current treatments only ease symptoms, so researchers are testing Silica 12CH, a homeopathic remedy, to determine if it offers additional benefits. The trial seeks individuals diagnosed with silicosis who are already receiving medical care for their condition. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, giving participants the opportunity to be among the first to receive this new treatment.

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 there any evidence suggesting that Silica 12CH is likely to be safe for humans?

Research has shown that Silica 12CH is being studied as a potential treatment for individuals with silicosis. This treatment remains in the early testing stages. Currently, studies have not provided specific safety information on Silica 12CH. Early-stage trials often offer limited information about side effects or how well participants tolerate the treatment.

In its natural form, silica can cause lung problems if inhaled over time, such as silicosis or lung damage. However, Silica 12CH is a highly diluted form, commonly used in homeopathy, which might mean it doesn't carry the same risks as raw silica. Still, due to the trial's early stage, there isn't enough evidence yet to confirm the safety or tolerability of Silica 12CH for individuals with silicosis. Participants should stay informed and discuss any concerns with the trial team. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Silicosis?

Silica 12CH is unique because it offers a homeopathic approach to treating silicosis, a lung disease traditionally managed with treatments like corticosteroids or bronchodilators. Unlike conventional medications that aim to reduce inflammation or ease breathing difficulties, Silica 12CH is derived from silica, a natural mineral, and is used in an ultra-diluted form. Researchers are excited about this treatment because it represents a potential alternative for patients seeking more natural or complementary options, and it might offer benefits without the side effects commonly associated with standard pharmaceuticals.

What evidence suggests that Silica 12CH might be an effective treatment for Silicosis?

Research is exploring Silica 12CH as a potential treatment for silicosis, a serious lung disease caused by inhaling silica dust. Currently, silicosis has no cure, and existing treatments only alleviate symptoms. Silica 12CH is a homeopathic remedy, meaning it is highly diluted. Homeopathy operates on the principle that such diluted substances can stimulate the body's self-healing. Although strong clinical evidence for Silica 12CH's effectiveness in treating silicosis is lacking, it is believed to potentially aid symptoms by enhancing the body's natural defenses. Further research is necessary to determine its true effectiveness. Participants in this trial will join an intervention group receiving Silica 12CH to assess its potential benefits. ^{4 6 7 8 9}

Who Is on the Research Team?

Alastair C Gray, PhD

Principal Investigator

HOHM Foundation

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12079053/

Early diagnosis and survival outcomes in silicosis the median duration of silica exposure and age at diagnosis for silicosis were 13 years and 61 years, respectively (16), with key risk factors ...

2. occup-med.biomedcentral.com occup-med.biomedcentral.com/articles/10.1186/s12995-025-00455-8

A review of silicosis and other silica-related diseases in the ... Silica exposure can result in one of three distinct disease patterns of silicosis: (1) chronic silicosis, typically developing after more than ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06011785?term=SILICON%20DIOXIDE&viewType=Table&rank=6

Using Silica 12CH to Mitigate the Effects and Symptoms of ... This clinical study aims to address a research and clinical treatment gap related to individuals with symptoms of Silicosis resulting from quartzite mining ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06011785

Using Silica 12CH to Mitigate the Effects and Symptoms of ... This clinical study aims to address a research and clinical treatment gap related to individuals with symptoms of Silicosis resulting from quartzite mining ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12213729/

Risk characterization for silica-related silicosis and lung ... Other studies have shown that reducing silica exposure from 0.1 mg/m3 to 0.05 mg/m3 may reduce associated lifetime risk of silicosis and lung ...

6. ussilica.com ussilica.com/sites/default/files/2022-11/Silica%20OSHA%20GHS%20SDS%20%286-22%29.pdf

U.S. SILICA COMPANY SAFETY DATA SHEET Chronic effects: Prolonged inhalation of respirable crystalline silica may cause lung disease, silicosis, lung cancer and other effects as ...

7. louisville.edu louisville.edu/micronano/files/documents/safety-data-sheets-sds/silica/

MSDS Crystalline Silica This material is considered hazardous under the OSHA Hazard Communications Standard (29 CFR 1910.1200). POTENTIAL HEALTH EFFECTS: Inhalation: a. Silicosis.

8. osha.gov osha.gov/silica-crystalline

Silica, Crystalline - Overview | Occupational Safety and ... Workers who inhale these very small crystalline silica particles are at increased risk of developing serious silica-related diseases, including: Silicosis, an ...

9. sigmaaldrich.com sigmaaldrich.com/US/en/sds/ALDRICH/777242?srsltid=AfmBOooUUjgnnRuieaTq2SIq1vsKS2ahl9vs0VmiC1bFlKDxlm880kEk

SAFETY DATA SHEET H372 Causes damage to organs (Lungs) through prolonged or repeated exposure if inhaled. Precautionary statements : Prevention: P201 Obtain ...