Steroids vs Placebo in Treatment of Tuberculous Lymphadenitis

January 23, 2024 updated by: Fahad Javed Awan

Role of Low Dose Steroids vs Placebo in Addition to Anti-tuberculosis Treatment (ATT) in Regression of Lymph Node Sizes in Patients With Tuberculous Lymphadenopathy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46000
        • Pak Emirates Military Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Deltacortil
Deltacortil 10mg was given in oral formulation once daily for 4 to 6 weeks
Drug: Deltacortril
Deltacortil 10mg was given orally once daily for 4 to 6 weeks
Other Names:
  • Prednisone
  • Dilacort
Placebo Comparator: Placebo
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.
Other Names:
  • Fenim
  • Fersul

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regression of size of cervical lymph nodes was measured using ultrasound neck
Time Frame: 4 to 5 weeks
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.
4 to 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fahad Javed Awan

Investigators

  • Principal Investigator: Fahad J Awan, MBBS, Pak Emirates Military Hospital
  • Principal Investigator: Muhammad Uneeb Ullah, MBBS, Pak Emirates Military Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

August 15, 2023

Study Registration Dates

First Submitted

December 26, 2023

First Submitted That Met QC Criteria

January 23, 2024

First Posted (Estimated)

February 1, 2024

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PakEmiratesMH1023Fahad

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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