An interventional study of Ferrous sulfate and Deltacortril in Tuberculous Lymphadenitis, Cervical, sponsored by Fahad Javed Awan. Completed at 1 site in Pakistan. Per ClinicalTrials.gov, last updated 2024-02-01.
Sponsored by Fahad Javed Awan · Not applicable, Interventional, and Treatment
This study will be conducted as a single blinded randomized control trial. The goal of this clinical trial is to learn about the role of low dose steroids in the resolution of tuberculous lymphadenitis. The prime questions, this clinical trial aims to answer are:
Patients presenting to the out patient department of Pak Emirates Military Hospital, Rawalpindi with tuberculous lymphadenitis will be recruited in the study after a written informed consent. Initial size of two largest lymph nodes will be measured. They will be randomized into two groups, only one of which will be receiving the low dose steroids.
The patients will be followed up on a monthly basis and regression in the lymph node size, if any will be measured. The two groups will be compared at the end of the trial.
Tuberculosis earliest records date back to the origin of civilization itself and yet still it remains one of the most elusive of the diseases still haunting the human population in the third world. Newer dugs and treatment protocols are still remain a major focus of discussion in the academic circles. Pakistan accounts for around 60% of the cases of tuberculosis in the East Mediterranean with an overall prevalence reaching 376 cases per 100,000 population. With such a high prevalence of the disease, it becomes punitive that robust TB control programs are run with an aim of not only rooting out the problem but also scientifically studying it so as to add useful information to the current literature available on the disease. This Randomized Control Trial is being conducted in the Pak-Emirates Military Hospital Rawalpindi, Pakistan which is a tertiary care hospital draining a vast area of the Punjab province of Pakistan since July, 2022 with a single blind study protocol. 140 patients with Tuberculous lymphadenitis of any site were recruited in the study after informed consent from 1st July 2022 till 30th June 2023. Patients were randomly assigned to two groups, A and B using lottery method. Group A is receiving the standard of care treatment for tuberculosis plus steroids in a low dose (10 mg per day) whereas Group B is receiving the standard of care plus a placebo. The regression of the size of lymph nodes is being recorded on a monthly follow up till completion of a 6 month standard Anti-tubercular treatment regimen. The data will be entered in the Statistical Package for Social Sciences version 23.00 at end of the trial and will be analyzed so as to compare the regression of the lymph node size between the two groups.
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's enrollment of 140 is close to the median of 150 across 952 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →This is the only study on the registry with Fahad Javed Awan as lead sponsor.
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Exclusion Criteria:
Deltacortil 10mg was given in oral formulation once daily for 4 to 6 weeks
Drug: Deltacortril
Iron 150mg was given in oral formulation once daily for 4 to 6 weeks
Drug: Ferrous sulfate
Ferrous Sulphate was given once daily for 4 to 6 weeks to the patients instead of deltacortil.
Also known as: Fenim, Fersul
Deltacortil 10mg was given orally once daily for 4 to 6 weeks
Also known as: Prednisone, Dilacort
Regression of size of cervical lymph nodes was measured using ultrasound neck
Ultrasound neck was done to measure the sizes of lymph nodes in the patients with tuberculous cervical lymphadenitis at the time of enrollment and then after 6 weeks to see the regression in the sizes of the cervical lymph nodes.
Time frame: 4 to 5 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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