Using Silica 12CH to Mitigate the Effects and Symptoms of Silicosis in Brazil

NCT06011785 | Not Yet Recruiting Early Phase 1 FDA Drug

• 1 other identifier: HOHMF
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Silicosis

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  One year

Study Arms (1)

Intervention Group

EXPERIMENTAL

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

Drug: Silica 12CH

Interventions

Silica 12CH DRUG

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)

Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• ● 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

Sponsors & Collaborators

• HOHM Foundation: lead

Study Sites (1)

HOHM Foundation

Philadelphia, Pennsylvania, 19138, United States

Location

Related Publications (7)

• 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.

  PMID: 28514023 RESULT

• Souza 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.

  PMID: 33774816 RESULT

• Carneiro 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.

  PMID: 28195659 RESULT

• Goyal 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.

  PMID: 12371452 RESULT

• Chand 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.

  PMID: 24685414 RESULT

• Hoeper 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.

  PMID: 17296674 RESULT

• Boccolini 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.

  PMID: 35918725 RESULT

MeSH Terms

Conditions

Silicosis

Interventions

gp100 Melanoma Antigen

Condition Hierarchy (Ancestors)

Pneumoconiosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lung Injury; Occupational Diseases

Intervention Hierarchy (Ancestors)

Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Melanoma-Specific Antigens; Neoplasm Proteins; Antigens, Neoplasm; Antigens; Biological Factors

Study Officials

• Alastair C Gray, PhD

  HOHM Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alastair C Gray, PhD

CONTACT

+13478192417; alastair.gray@hohmfoundation.org

Parker Pracjek, MA

CONTACT

+573203671782; parker.pracjek@hohmfoundation.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: No masking required.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Research

Model Details: 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.

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 25, 2023
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)