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

Status Not yet recruiting

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Silicosis

Clinical Trial Details

NCT number	NCT06011785
Study type	Interventional
Source	HOHM Foundation
Contact	Alastair C Gray, PhD
Phone	+13478192417
Email	alastair.gray@hohmfoundation.org
Status	Not yet recruiting
Phase	Early Phase 1
Start date	March 1, 2024
Completion date	March 1, 2026

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT01329003` - DNA-damage Pathways in Workers Exposed to Silica (Caesar Stone)	N/A
Not yet recruiting	`NCT01338064` - Oxidative Stress Biomarkers to Monitor and Early Detect Health Impairment in Workers Exposed to Silica (Caesar Stone)	N/A
Recruiting	`NCT04161014` - The Nintedanib in Progressive Pneumoconiosis Study (NiPPS): a Collaborative NSW Treatment Trial	Phase 2
Recruiting	`NCT05118256` - Pirfenidone for the Reduction of Metabolic, Inflammatory and Fibrogenic Activity in Complicated Silicosis	Phase 2
Completed	`NCT02430259` - Efficacy of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention	Phase 3
Recruiting	`NCT06403800` - Silicosis and Silicotuberculosis Among Small Scale Gemstone Miners in Northern Tanzania
Not yet recruiting	`NCT05402176` - The SHIELD Whole Lung Lavage Study
Completed	`NCT02794701` - Comprehensive Risk Assessment of People With Silicosis: A Population-based Study
Completed	`NCT01977131` - Safety Study of Autologous Bone Marrow Stromal Cells With Modification by Hepatocyte Growth Factor to Treat Silicosis	Phase 1/Phase 2
Completed	`NCT00005280` - Specialized Center of Research in Occupational and Immunologic Lung Disease	N/A
Recruiting	`NCT05538299` - Silicosis Treatment, Action, Screening and Surveillance in Rwanda Trials
Completed	`NCT01725971` - Oscillation Mechanics of the Respiratory System in Never-smoking Patients With Silicosis	N/A
Recruiting	`NCT06090370` - Reducing Silica Exposure Among Brick Kiln Workers in Nepal	N/A
Completed	`NCT04205708` - Screening Strategy for Early Diagnosis of Silicosis in At-Risk Populations in Oklahoma
Recruiting	`NCT05546944` - The SHIELD Study-silicosis

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms