None listed
Conditions
Interventions
Intervention1: Duodenal release Prussian blue oral formulation (200 MG): Dose: Duodenal release Prussian blue oral formulation (200 MG)three times a day for 3 days
Duration of the protocol therapy: 3 days
Control Intervention1: 1000 MG of conventional Prussian blue oral formulation: Dose: 1000 MG of conventional Prussian blue oral formulation three times a day f
Duration of protocol therapy: 3 days
Sponsors
Defence R&D Organisation
Eligibility
Inclusion criteria
Inclusion criteria: 1. Cohort shall be chosen from patients undergoing Tl-201 scintigraphy at INMAS (DRDO) for whatever reason. 2. Age: 45-70 years 3. Only those patients shall be chosen for the study who actually require Tl-201 scintigraphy for betterment of their health, and who understand that they stand to gain in terms of reduction of radiation damage through this test. 4. Only those subjects shall undergo the study whose referring physicians give approval for the study 5. INMAS cardiologist shall clear each patient 6. Able to undergo testing /evaluation at INMAS OPD for 5-6 times in 2 weeks
Exclusion criteria
Exclusion criteria: 1. Patients with prior hypersensitivity to PB or other excipients of the test medicine, or severely constipated ones. 2. Patients who are unwilling to give informed consent. 3. Patients with illness or other factors which may make it doubtful or inconvenient for them to attend INMAS OPD for tests at least 6 times in 2 weeks. 4. Patients whose treatment schedule is likely to change in the weeks required for the test or whose medications are likely to interfere or get interfered from Tl-201 or test/control medication kinetics. 5. Patients receiving barium sulphate or any such heavy salt for any purpose. 6. Females in the reproductive age group, or who carry even remote chance of pregnancy 7. Patients with gall bladder stones, gall-bladder disease, poor gall bladder contractility, gall bladder removal etc. 8. Patients with clinically significant renal, respiratory (other than asthma), cardiac (including rheumatic or congenital heart disease), gastrointestinal, hepatic, endocrine or hematological disorders. 9. Patients with history of chronic or severe constipation. 10. Patients with functional or organic gastric outlet obstruction. 11. Patients who have any medical condition which in the judgement of the investigator may render them in appropriate for participation in the trial. 13. Patients who have received any other investigational drug for the last 1 month. 14. Pregnant & lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate the efficacy of conventional Prussian Blue formulation (1000 MG) in removal of Tl-201 from the body 2. To evaluate the efficacy of duodenal release formulation of Prussian Blue (200 MG) for the same purpose 3. To compare the performance of the above two on the basis of decorporation data obtained Timepoint: NIL | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To confirm duodenal release of the formulation 2. To evaluate the safety and tolerability of study medication 3. To look for constipating effect of the control and test formulations 4. To evaluate the effect of treatment with the study medication on whole body and organ-specific distribution of radioactivity pattern 5. To image the pharmacological effect of the medications by scintigraphy 6. To evaluate the physicians and patients overall assessment of the effectiveness and tolerability of the study medication in patients Timepoint: NIL | — |
Countries
India
Contacts
Public ContactAseem Bhatnagar
Institute of Nuclear Medicine & Allied Sciences, Defence R&D Organisation, Ministry of Defence
Outcome results
None listed