SilicosisEarly Phase 1HOHMNCT06011785
Using Silica 12CH to Mitigate the Effects and Symptoms of Silicosis in Brazil
A Early Phase 1 study testing Silica 12CH in people with Silicosis, run by HOHM Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Silicosis
- What is being tested?
- Silica 12CH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 1 Mar 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- ● 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
Show all 9Show fewer
- legal or clinically incapable persons
- person in a state of temporary disability;
- of a member of indigenous community
Trial locations and contacts
1 site in 1 country.
United States1 site
HOHM Foundation
Philadelphia, Pennsylvania, 19138
Alastair C Gray, PhD, 347-819-2417, alastair.gray@hohmfoundation.org
Parker Pracjek, MA, +573203671782, parker.pracjek@hohmfoundation.org
About this study
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.
Read the 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.
- Conditions
- Silicosis
- Being tested
- Silica 12CH
- Medical subject headings
- Silicosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silica 12CHDrug
Also called Silicea terra (sil)
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants have Silicosis and wish to be included in the intervention group Receives: Drug: Silica 12CH |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One year
Secondary outcomes (1)
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
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 Mar 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SilicosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HOHM Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alastair Gray, HOHM Foundation
- Investigators
- Alastair C Gray, PhD, Principal investigator, HOHM Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011785
- Sponsor's protocol ID
- HOHMF
- Acronym
- HOHM
- Status last verified
- Feb 2024
- First submitted
- 24 Jul 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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).
Publications
Souza TP, Watte G, Gusso AM, Souza R, Moreira JDS, Knorst MM. Silicosis prevalence and risk factors in semi-precious stone mining in Brazil. Am J Ind Med. 2017 Jun;60(6):529-536. doi: 10.1002/ajim.22719.
PubMed 28514023Souza TP, van Tongeren M, Monteiro I. Respiratory health and silicosis in artisanal mine workers in southern Brazil. Am J Ind Med. 2021 Jun;64(6):511-518. doi: 10.1002/ajim.23242. Epub 2021 Mar 28.
PubMed 33774816Carneiro AP, Braz NF, Algranti E, Bezerra OM, Araujo NP, Amaral Eng Hyg LS, Edme JL, Sobaszek A, Cherot-Kornobis N. Silica exposure and disease in semi-precious stone craftsmen, Minas Gerais, Brazil. Am J Ind Med. 2017 Mar;60(3):239-247. doi: 10.1002/ajim.22682.
PubMed 28195659Goyal KK. Two cases of pulmonary TB treated with homeopathy. Homeopathy. 2002 Jan;91(1):43-6. doi: 10.1054/homp.2001.0009. No abstract available.
PubMed 12371452Chand KS, Manchanda RK, Mittal R, Batra S, Banavaliker JN, De I. Homeopathic treatment in addition to standard care in multi drug resistant pulmonary tuberculosis: a randomized, double blind, placebo controlled clinical trial. Homeopathy. 2014 Apr;103(2):97-107. doi: 10.1016/j.homp.2013.12.003.
PubMed 24685414Hoeper MM, Welte T. Systemic inflammation, COPD, and pulmonary hypertension. Chest. 2007 Feb;131(2):634-5; author reply 635. doi: 10.1378/chest.06-2207. No abstract available.
PubMed 17296674Boccolini PMM, de Lima Sirio Boclin K, de Sousa IMC, Boccolini CS. Prevalence of complementary and alternative medicine use in Brazil: results of the National Health Survey, 2019. BMC Complement Med Ther. 2022 Aug 2;22(1):205. doi: 10.1186/s12906-022-03687-x.
PubMed 35918725
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Silica 12CH to Mitigate the Effects and Symptoms of Silicosis in Brazil
- ClinicalTrials.gov ID
- NCT06011785
- Acronym / sponsor ID
- HOHM / HOHMF
- Conditions
- Silicosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- HOHM FoundationUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: Silica 12CHParticipants have Silicosis and wish to be included in the intervention group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To be eligible to participate, participants must meet the following criteria:
Key exclusion criteria (9 listed)
- ● Individuals under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silica 12CHAlso: Silicea terra (sil)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. | Drug | Intervention Group |
Primary outcome
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
Time frame: One year
Monitor changes using validated wellness measurement instrument
1 secondary outcome
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.
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Results publication: PubMed 28514023Souza TP, Watte G, Gusso AM, Souza R, Moreira JDS, Knorst MM. Silicosis prevalence and risk factors in semi-precious stone mining in Brazil. Am J Ind Med. 2017 Jun;60(6):529-536. doi: 10.1002/ajim.22719.
- Results publication: PubMed 33774816Souza TP, van Tongeren M, Monteiro I. Respiratory health and silicosis in artisanal mine workers in southern Brazil. Am J Ind Med. 2021 Jun;64(6):511-518. doi: 10.1002/ajim.23242. Epub 2021 Mar 28.
- Results publication: PubMed 28195659Carneiro AP, Braz NF, Algranti E, Bezerra OM, Araujo NP, Amaral Eng Hyg LS, Edme JL, Sobaszek A, Cherot-Kornobis N. Silica exposure and disease in semi-precious stone craftsmen, Minas Gerais, Brazil. Am J Ind Med. 2017 Mar;60(3):239-247. doi: 10.1002/ajim.22682.
- Results publication: PubMed 12371452Goyal KK. Two cases of pulmonary TB treated with homeopathy. Homeopathy. 2002 Jan;91(1):43-6. doi: 10.1054/homp.2001.0009. No abstract available.
- Results publication: PubMed 24685414Chand KS, Manchanda RK, Mittal R, Batra S, Banavaliker JN, De I. Homeopathic treatment in addition to standard care in multi drug resistant pulmonary tuberculosis: a randomized, double blind, placebo controlled clinical trial. Homeopathy. 2014 Apr;103(2):97-107. doi: 10.1016/j.homp.2013.12.003.
- Results publication: PubMed 17296674Hoeper MM, Welte T. Systemic inflammation, COPD, and pulmonary hypertension. Chest. 2007 Feb;131(2):634-5; author reply 635. doi: 10.1378/chest.06-2207. No abstract available.
- Results publication: PubMed 35918725Boccolini PMM, de Lima Sirio Boclin K, de Sousa IMC, Boccolini CS. Prevalence of complementary and alternative medicine use in Brazil: results of the National Health Survey, 2019. BMC Complement Med Ther. 2022 Aug 2;22(1):205. doi: 10.1186/s12906-022-03687-x.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alastair C Gray, PhD principal investigator
HOHM Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Silica 12CH in people with Silicosis, run by HOHM Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alastair C Gray, PhD (+13478192417, alastair.gray@hohmfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06011785, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.