- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06236152
Steroids vs Placebo in Treatment of Tuberculous Lymphadenitis
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
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Rawalpindi, Punjab, Pakistan, 46000
- Pak Emirates military hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
1. Newly diagnosed patients with tuberculosis having painful tuberculous lymphadenopathy
Exclusion Criteria:
- Patients with no tuberculous lymphadenopathy.
- Patients who are already under treatment for tuberculosis.
- Patient who developed complications due to anti-TB treatment
Study Plan
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
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Deltacortil 10mg was given orally once daily for 4 to 6 weeks
Other Names:
|
Placebo Comparator: Placebo
Iron 150mg was given in oral formulation once daily for 4 to 6 weeks
|
Ferrous Sulphate was given once daily for 4 to 6 weeks to the patients instead of deltacortil.
Other Names:
|
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
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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.
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4 to 5 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fahad J Awan, MBBS, Pak Emirates military hospital
- Principal Investigator: Muhammad Uneeb Ullah, MBBS, Pak Emirates military hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Lymphatic Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Mycobacterium Infections
- Tuberculosis, Extrapulmonary
- Tuberculosis
- Lymphadenopathy
- Lymphadenitis
- Tuberculosis, Lymph Node
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Prednisone
Other Study ID Numbers
- PakEmiratesMH1023Fahad
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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