Steroids vs Placebo in Treatment of Tuberculous Lymphadenitis

NCT ID: NCT06236152

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-08-15

Brief Summary

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:

• Is there any role of starting low dose steroids in resolution of lymph node size along side standard anti-tubercular drugs in patients of tuberculous lymphadenitis?
• Do low dose steroid therapy in addition to standard anti-TB drugs prevents or reduces the incidence of complications?

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.

Detailed Description

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.

Conditions

Tuberculous Lymphadenitis, Cervical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Deltacortil

Deltacortil 10mg was given in oral formulation once daily for 4 to 6 weeks

Group Type: ACTIVE_COMPARATOR

Deltacortril

Intervention Type: DRUG

Deltacortil 10mg was given orally once daily for 4 to 6 weeks

Placebo

Iron 150mg was given in oral formulation once daily for 4 to 6 weeks

Group Type: PLACEBO_COMPARATOR

Ferrous sulfate

Intervention Type: DRUG

Ferrous Sulphate was given once daily for 4 to 6 weeks to the patients instead of deltacortil.

Interventions

Ferrous sulfate

Ferrous Sulphate was given once daily for 4 to 6 weeks to the patients instead of deltacortil.

Intervention Type: DRUG

Deltacortril

Deltacortil 10mg was given orally once daily for 4 to 6 weeks

Intervention Type: DRUG

Other Intervention Names

Fenim; Fersul; Prednisone; Dilacort

Eligibility Criteria

Inclusion Criteria

1. Newly diagnosed patients with tuberculosis having painful tuberculous lymphadenopathy

Exclusion Criteria

1. Patients with no tuberculous lymphadenopathy.

2. Patients who are already under treatment for tuberculosis.

3. Patient who developed complications due to anti-TB treatment

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fahad Javed Awan

OTHER

Sponsor Role: lead

Responsible Party

Fahad Javed Awan

Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Fahad J Awan, MBBS

Role: PRINCIPAL_INVESTIGATOR

Pak Emirates Military Hospital

Muhammad Uneeb Ullah, MBBS

Role: PRINCIPAL_INVESTIGATOR

Pak Emirates Military Hospital

Locations

Pak Emirates Military Hospital

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

PakEmiratesMH1023Fahad

Identifier Type: -

Identifier Source: org_study_id