Tuberculous Lymphadenitis, CervicalNCT06236152
Steroids vs Placebo in Treatment of Tuberculous Lymphadenitis
A study testing Ferrous sulfate and Deltacortril in people with Tuberculous Lymphadenitis, Cervical, run by Fahad Javed Awan at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tuberculous Lymphadenitis, Cervical
- What is being tested?
- Ferrous sulfate and Deltacortril
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2022to 15 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Newly diagnosed patients with tuberculosis having painful tuberculous lymphadenopathy
Who cannot join
- Patients with no tuberculous lymphadenopathy.
- Patients who are already under treatment for tuberculosis.
- Patient who developed complications due to anti-TB treatment
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pak Emirates Military Hospital
Rawalpindi, Punjab Province, 46000
About this study
Official title: 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?
Read more
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.
Read the 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
- Being tested
- Ferrous sulfate, Deltacortril
- Keywords
- Painful cervical lymphadenopathy, Tuberculosis, Tuberculous Lymphadenitis
- Medical subject headings
- Tuberculosis, Lymph Node, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous sulfateDrug
Also called Fenim, Fersul
Ferrous Sulphate was given once daily for 4 to 6 weeks to the patients instead of deltacortil.
DeltacortrilDrug
Also called Prednisone, Dilacort
Deltacortil 10mg was given orally once daily for 4 to 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Deltacortil | Active comparator | Deltacortil 10mg was given in oral formulation once daily for 4 to 6 weeks Receives: Drug: Deltacortril |
| Placebo | Placebo comparator | Iron 150mg was given in oral formulation once daily for 4 to 6 weeks Receives: Drug: Ferrous sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Jul 2022
- Primary completion30 Jun 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculous Lymphadenitis, CervicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fahad Javed Awan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fahad Javed Awan, Pak Emirates Military Hospital
- Investigators
- Fahad J Awan, MBBS, Principal investigator, Pak Emirates Military HospitalMuhammad Uneeb Ullah, MBBS, Principal investigator, Pak Emirates Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236152
- Sponsor's protocol ID
- PakEmiratesMH1023Fahad
- Status last verified
- Jan 2024
- First submitted
- 26 Dec 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06236152
- Acronym / sponsor ID
- PakEmiratesMH1023Fahad
- Conditions
- Tuberculous Lymphadenitis, Cervical
- Keywords
- Painful cervical lymphadenopathy, Tuberculosis, Tuberculous Lymphadenitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Fahad Javed AwanUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Deltacortil | Active comparator | Drug: DeltacortrilDeltacortil 10mg was given in oral formulation once daily for 4 to 6 weeks |
| Placebo | Placebo comparator | Drug: Ferrous sulfateIron 150mg was given in oral formulation once daily for 4 to 6 weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Newly diagnosed patients with tuberculosis having painful tuberculous lymphadenopathy
Key exclusion criteria (3 listed)
- Patients with no tuberculous lymphadenopathy.
- Patients who are already under treatment for tuberculosis.
- Patient who developed complications due to anti-TB treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferrous sulfateAlso: Fenim, FersulFerrous Sulphate was given once daily for 4 to 6 weeks to the patients instead of deltacortil. | Drug | Placebo |
| DeltacortrilAlso: Prednisone, DilacortDeltacortil 10mg was given orally once daily for 4 to 6 weeks | Drug | Deltacortil |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fahad J Awan, MBBS principal investigator
Pak Emirates Military Hospital
Muhammad Uneeb Ullah, MBBS principal investigator
Pak Emirates Military Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferrous sulfate and Deltacortril in people with Tuberculous Lymphadenitis, Cervical, run by Fahad Javed Awan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regression of size of cervical lymph nodes was measured using ultrasound neck (time frame: 4 to 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.