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Evaluation of the effect of radioprotection on chest protection in patients undergoing lung CT scan

Evaluation of the radioprotective effect of melatonin and bismuth chest shield on radiation-induced apoptosis and gene expression in female patients undergoing lung CT scan, a randomized, double blind, placebo controlled clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231218060453N2
Enrollment
60
Registered
2025-05-08
Start date
2025-05-06
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Condition 1: Rate of apoptosis (cell death). Condition 2: Gene expression changes. Condition 3: Entrance Skin Dose. Condition 4: Dose Length Product.

Interventions

Intervention 1: ?First intervention group: Patients undergoing lung CT scans take one 10 mg sublingual melatonin tablet 9-12 hours before the CT scan and one 10 mg sublingual melatonin tablet 30 minut

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age range over 18 years old Having informed consent Referred for CT scan

Exclusion criteria

Exclusion criteria: Known allergy to the study drug Use of progestin-based medications, herbal sedatives, 5 HTP supplements, blood thinners (such as warfarin, heparin), blood pressure medications (especially nifedipine), medications that may affect the immune system (such as azathioprine, cyclosporine, prednisone), sleeping pills or anti-anxiety medications (such as diazepam, alprazolam), antihistamines (such as cetirizine, diphenhydramine), muscle relaxants and pain relievers (such as codeine), fluvoxamine Undergoing surgery, chemotherapy, or radiotherapy within one month prior to the study Having a CT scan one month before the study Having an active viral infection within one week before the imaging procedure Having seizures and convulsive diseases Being pregnant Being breast-feeding

Design outcomes

Primary

MeasureTime frame
Apoptosis (cell death). Timepoint: 30 minutes before the intervention and 24 hours after the test. Method of measurement: Counting the number of apoptotic peripheral blood lymphocytes by flow cytometry.;Gene expression changes. Timepoint: 30 minutes before the intervention and 24 hours after the test. Method of measurement: Real-Time PCR.;Entrance Skin Dose (ESD). Timepoint: When performing a CT scan. Method of measurement: Thermoluminescent Dosimeter (TLD).;Dose length Product (DLP). Timepoint: after a CT scan. Method of measurement: Measurement using information on the CT scan machine.

Secondary

MeasureTime frame
Side effects. Timepoint: All patients are given a phone number to call in case of emergency, while taking melatonin and for 24-48 hours afterwards if needed, to report any side effects caused by the medication. Method of measurement: Control by a specialist physician and radiologist present in the plan.;Reducing the risk of cancer. Timepoint: After sampling is completed. Method of measurement: Based on data collected from patients CT scan and using IMPACT software.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Shadi Shafaghi

Shahid Beheshti University of Medical Sciences

shafaghishadi@yahoo.com+98 21 2712 2175

Outcome results

None listed

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