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Prospective and one-arm clinical study on the effectiveness and safety of methyl sulfonite granules in the treatment of cough and pneumonia nodules

Prospective and one-arm clinical study on the effectiveness and safety of methyl sulfonite granules in the treatment of cough and pneumonia nodules

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079923
Enrollment
Unknown
Registered
2024-01-16
Start date
2024-01-18
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cough with pneumonia nodules

Interventions

Experimental group:Take methyl sulfonate granules(8 weeks of treatment, 2 bags at a time, tid)

Sponsors

Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age = 18 years old and = 75 years old; 2. In line with the diagnostic criteria for cough and pulmonary inflammatory small nodules, CT scan or enhanced CT or PET-CT shows that both lungs have isolated solid nodules with a diameter of = 8mm; 3. Patients (including partners) have no infertility, sperm donation, egg donation plan and voluntary effective contraceptive measures from the signing of the informed consent to the end of the test; 4. After full informed consent, the patient voluntarily participates in the study and signs a written informed consent form, and agrees to comply with the procedures stipulated in the research plan;

Exclusion criteria

Exclusion criteria: 1. Those who are allergic to the experimental drugs in this study; 2. Patients with pulmonary nodules judged by researchers to require surgery or puncture biopsy; 3. Have malignant tumors (except for any type of in-situ cancer, basal cell and squamous cell skin cancer that has been completely removed or other tumors/cancers that have been radically treated and have no signs of disease for at least 3 years); 4. Alanine aminotransferase (ALT), almonine aminotransferase (AST) is greater than 3 × upper limit of normal value (ULN) 5. Pregnant and lactating women, or severe pulmonary and cardiac insufficiency, liver and kidney dysfunction, or other serious diseases that affect their survival, patients with severe trauma and major after surgery, mental patients; 6. Those who have participated in clinical trials of other drugs and devices within 3 months before selection (except those who have participated in other trials without drugs or intervention), or those who plan to participate in other clinical trials during the period of participation in this trial; 7. Other researchers believe that it is not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Changes in the score of the concise cough scale relative to the baseline on the 8th weekend after the first administration;

Secondary

MeasureTime frame
CT imaging shows the change of nodule diameter and baseline on the 8th weekend after the first administration;

Countries

China

Contacts

Public ContactChen Chongli

Hospital of Chengdu University of Traditional Chinese Medicine

821553354@qq.com+86 159 8231 5058

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026