Steroids vs Placebo in Treatment of Tuberculous Lymphadenitis
NCT06236152 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140
Last updated 2024-02-01
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.
Conditions
- Tuberculous Lymphadenitis, Cervical
Interventions
- DRUG
-
Ferrous sulfate
Ferrous Sulphate was given once daily for 4 to 6 weeks to the patients instead of deltacortil.
- DRUG
-
Deltacortril
Deltacortil 10mg was given orally once daily for 4 to 6 weeks
Sponsors & Collaborators
-
Fahad Javed Awan
lead OTHER
Principal Investigators
-
Fahad J Awan, MBBS · Pak Emirates Military Hospital
-
Muhammad Uneeb Ullah, MBBS · Pak Emirates Military Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-01
- Primary Completion
- 2023-06-30
- Completion
- 2023-08-15
Countries
- Pakistan
Study Locations
More Related Trials
-
Rosuvastatin Evaluation as a Tuberculosis Treatment Adjunct
NCT04504851 ·Status: UNKNOWN ·Phase: PHASE2
-
A Multiple Ascending Dose Study With a Dose Formulation Comparison Cohort to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBA-354 in Healthy Adult Subjects
NCT02606214 ·Status: TERMINATED ·Phase: PHASE1
-
Oral Nutritional Supplementation and Weight Changes During Therapy in Malnourished Patients With Resistant Tuberculosis: A Clinical Trial
NCT07058233 ·Status: COMPLETED ·Phase: NA
-
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With Clofazimine (C)-TMC207 (J)-PA-824 (Pa)-Pyrazinamide (Z)
NCT01691534 ·Status: COMPLETED ·Phase: PHASE2
-
A Controlled Smoking Cessation Trial and Prospective Cohort Study of Tuberculosis (TB) Treatment Outcomes
NCT02238405 ·Status: COMPLETED ·Phase: NA
-
The Impact of Malnutrition on Immune Responses to Tuberculosis
NCT05044910 ·Status: ACTIVE_NOT_RECRUITING
-
Effect of Filarial Infection on Immune Responses in Latent Tuberculosis
NCT01547884 ·Status: COMPLETED
-
NexGen EBA Radiologic and Immunologic Biomarkers of Sterilizing Drug Activity in Tuberculosis
NCT02371681 ·Status: COMPLETED ·Phase: PHASE2
-
A Safety and Immunogenicity Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31)
NCT01049282 ·Status: COMPLETED ·Phase: PHASE1
-
Treating Tuberculosis Wasting With a High-protein Supplement
NCT03302949 ·Status: TERMINATED ·Phase: NA
-
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBA-354 in Healthy Adult Subjects
NCT02288481 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluating the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, For Drug-Resistant Pulmonary Tuberculosis
NCT02583048 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of the Safety, Tolerability, and Absorption, Metabolism, and Excretion of PA-824 in Healthy Adult Male Subjects.
NCT03202693 ·Status: COMPLETED ·Phase: PHASE1
-
Treatment of Latent Tuberculosis Infection With Isoniazid
NCT00293228 ·Status: COMPLETED ·Phase: PHASE4
-
Tuberculosis - Learning the Impact of Nutrition
NCT03598842 ·Status: COMPLETED ·Phase: NA
-
Efficacy and Safety of Immunomodulator as an Adjunct Therapy in New Pulmonary Tuberculosis(Category I) Patients.
NCT00341328 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB
NCT05221502 ·Status: COMPLETED ·Phase: PHASE2
-
Tuberculosis Drug Levels in Diabetics
NCT04242511 ·Status: UNKNOWN
-
PRecision biomArker-Guided MAnagement of TuberculosIs Contacts: a Discrete Choice Experiment
NCT07024836 ·Status: RECRUITING
-
The Optimal Duration of Preoperative Anti-tuberculosis Treatment of Spinal Tuberculosis
NCT02477852 ·Status: UNKNOWN ·Phase: PHASE4
-
Reactogenicity, Safety and Immunogenicity of a TB/FLU-04L Tuberculosis Vaccine
NCT02501421 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy of Antituberculous Therapy in Management of Sarcoidosis
NCT01245036 ·Status: COMPLETED ·Phase: NA
-
Biomarkers for Therapy Response in Drug-resistant Tuberculosis
NCT02597621 ·Status: COMPLETED
-
Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis
NCT05971602 ·Status: TERMINATED ·Phase: PHASE2
-
Point-of-care Triage Test for Active Tuberculosis
NCT04232618 ·Status: UNKNOWN