Umbilical GranulomaNCT05545462
Comparison Of Doxycycline And Common Salt For Treatment Of Umbilical Granuloma: A Randomised Control Trial
A study testing Doxycyclin and COMMON SALT in people with Umbilical Granuloma, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
Trial summary
it is the study for the disease called umbilical granuloma to look for the better treatment option which can be performed by healthcare physicians and local nurses and even parents Read more about this study
- Who is it for?
- Ages 1 month to 1 year
- Conditions the study is for
- Umbilical Granuloma
- What is being tested?
- Doxycyclin and COMMON SALT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2020to 30 Sep 2021
- 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 1 month to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates and infants (age<1yr)
- Both genders
- Confirmed by ultrasonography and sinography (if applicable)
Who cannot join
- 1. If any treatment is already given 2. Patient lost in follow up 3. Refusal
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan institute of medical Sciences/ Shaheed Zulfiqar Ali Bhutto Medical University
Islamabad
About this study
Official title: Comparison Of Doxycycline And Common Salt (TableCooking) For Treatment Of Umbilical Granuloma In Children: A Randomised Control Trial
it is the study for the disease called umbilical granuloma to look for the better treatment option which can be performed by healthcare physicians and local nurses and even parents
Read the detailed description
umbilical granuloma is a condition for which multiple treatments are available those including interventional and non interventional, most of the treatments are performed by the health care physician like application of silver nitrate cryotherapy, electrocautery, double ligation.
the main goal of this study is to prefer those method or drugs which could be safely used by the nurses the health care personal and even by parents at home with fewer side effects
- Conditions
- Umbilical Granuloma
- Being tested
- Doxycyclin, COMMON SALT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclinDrug
Also called COMMON SALT
THE USE OF DOXYCYCLIN POWDER IN THE TREATMENT OF UMBILICAL GRANULOMA
COMMON SALTOther
THE USE OF COMMON SALT IN TREATMENT OF UMBILICAL GRANULOMA
| Study group | Role | What they receive |
|---|---|---|
| COMPARISON OF DOXYCYCLINE AND COMMON SALT FOR TREATMENT OF UMBILICAL GRANULOMA IN CHILDREN | Experimental | to study the comparison of doxycycline and common salt for the treatment of umbilical granuloma to check which is more effective safe timesaving and can be performed by even parents it showed that common salt is more effective than doxycycline Receives: Drug: Doxycyclin |
| COMPARISON BETWEEN COMMON SALT AND SOXYCYLIN FOR TREATMENT OF UMBILICAL GRANULOMA | Experimental | to study the comparison of doxycycline and common salt for the treatment of umbilical granuloma to check which is more effective safe timesaving and can be performed by even parents it showed that common salt is more effective than doxycycline Receives: Other: COMMON SALT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison Of Doxycycline And Common Salt (TableCooking) For Treatment Of Umbilical Granuloma In Children: A Randomised Control Trial
for the treatment of Umbilical Granuloma multiple treatment options are available. and we have studied about the two methods the common salt any doxycycline The use of common salt to treat umbilical granuloma is a simple, highly effective, and inexpensive with minimum complications or relapse as compared to doxycycline. Treatment can be performed by physicians, nurses, primary health-care staff in remote areas, and even by parents.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start1 Oct 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Umbilical GranulomaStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.M. Awais, Shaheed Zulfiqar Ali Bhutto Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545462
- Sponsor's protocol ID
- 356/SZABMU/MS-2017
- Status last verified
- Sep 2022
- First submitted
- 12 Sep 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Doxycycline And Common Salt (TableCooking) For Treatment Of Umbilical Granuloma In Children: A Randomised Control Trial
- ClinicalTrials.gov ID
- NCT05545462
- Acronym / sponsor ID
- 356/SZABMU/MS-2017
- Conditions
- Umbilical Granuloma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 19 Sep 2022 (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.
it is the study for the disease called umbilical granuloma to look for the better treatment option which can be performed by healthcare physicians and local nurses and even parents
Detailed description
umbilical granuloma is a condition for which multiple treatments are available those including interventional and non interventional, most of the treatments are performed by the health care physician like application of silver nitrate cryotherapy, electrocautery, double ligation.
the main goal of this study is to prefer those method or drugs which could be safely used by the nurses the health care personal and even by parents at home with fewer side effects
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COMPARISON OF DOXYCYCLINE AND COMMON SALT FOR TREATMENT OF UMBILICAL GRANULOMA IN CHILDREN | Experimental | Drug: Doxycyclinto study the comparison of doxycycline and common salt for the treatment of umbilical granuloma to check which is more effective safe timesaving and can be performed by even parents it showed that common salt is more effective than doxycycline |
| COMPARISON BETWEEN COMMON SALT AND SOXYCYLIN FOR TREATMENT OF UMBILICAL GRANULOMA | Experimental | Other: COMMON SALTto study the comparison of doxycycline and common salt for the treatment of umbilical granuloma to check which is more effective safe timesaving and can be performed by even parents it showed that common salt is more effective than doxycycline |
Who may qualify
- Ages
- 1 month to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
Key exclusion criteria (1 listed)
- 1. If any treatment is already given 2. Patient lost in follow up 3. Refusal
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 |
|---|---|---|
| DoxycyclinAlso: COMMON SALTTHE USE OF DOXYCYCLIN POWDER IN THE TREATMENT OF UMBILICAL GRANULOMA | Drug | COMPARISON OF DOXYCYCLINE AND COMMON SALT FOR TREATMENT OF UMBILICAL GRANULOMA IN CHILDREN |
| COMMON SALTTHE USE OF COMMON SALT IN TREATMENT OF UMBILICAL GRANULOMA | Other | COMPARISON BETWEEN COMMON SALT AND SOXYCYLIN FOR TREATMENT OF UMBILICAL GRANULOMA |
Primary outcome
Comparison Of Doxycycline And Common Salt (TableCooking) For Treatment Of Umbilical Granuloma In Children: A Randomised Control Trial
Time frame: 1 year
for the treatment of Umbilical Granuloma multiple treatment options are available. and we have studied about the two methods the common salt any doxycycline The use of common salt to treat umbilical granuloma is a simple, highly effective, and inexpensive with minimum complications or relapse as compared to doxycycline. Treatment can be performed by physicians, nurses, primary health-care staff in remote areas, and even by parents.
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 19 Sep 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doxycyclin and COMMON SALT in people with Umbilical Granuloma, run by Shaheed Zulfiqar Ali Bhutto Medical University 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 3 inclusion and 1 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 19 Sep 2022. 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. 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?
Comparison Of Doxycycline And Common Salt (TableCooking) For Treatment Of Umbilical Granuloma In Children: A Randomised Control Trial (time frame: 1 year). 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 19 Sep 2022.