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Comparison Of Doxycycline And Common Salt For Treatment Of Umbilical Granuloma: A Randomised Control Trial

Primary Purpose

Umbilical Granuloma

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Doxycyclin
COMMON SALT
Sponsored by
Shaheed Zulfiqar Ali Bhutto Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Umbilical Granuloma

Eligibility Criteria

1 Month - 1 Year (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inclusion criteria:

    1. Neonates and infants (age<1yr)
    2. Both genders
    3. Confirmed by ultrasonography and sinography (if applicable)

Exclusion Criteria:

  • 1. If any treatment is already given 2. Patient lost in follow up 3. Refusal

Sites / Locations

  • Pakistan institute of medical Sciences/ Shaheed Zulfiqar Ali Bhutto Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

COMPARISON OF DOXYCYCLINE AND COMMON SALT FOR TREATMENT OF UMBILICAL GRANULOMA IN CHILDREN

COMPARISON BETWEEN COMMON SALT AND SOXYCYLIN FOR TREATMENT OF UMBILICAL GRANULOMA

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 12, 2022
Last Updated
September 16, 2022
Sponsor
Shaheed Zulfiqar Ali Bhutto Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05545462
Brief Title
Comparison Of Doxycycline And Common Salt For Treatment Of Umbilical Granuloma: A Randomised Control Trial
Official Title
Comparison Of Doxycycline And Common Salt (TableCooking) For Treatment Of Umbilical Granuloma In Children: A Randomised Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shaheed Zulfiqar Ali Bhutto Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Umbilical Granuloma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
196 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COMPARISON OF DOXYCYCLINE AND COMMON SALT FOR TREATMENT OF UMBILICAL GRANULOMA IN CHILDREN
Arm Type
Experimental
Arm Description
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
Arm Title
COMPARISON BETWEEN COMMON SALT AND SOXYCYLIN FOR TREATMENT OF UMBILICAL GRANULOMA
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Doxycyclin
Other Intervention Name(s)
COMMON SALT
Intervention Description
THE USE OF DOXYCYCLIN POWDER IN THE TREATMENT OF UMBILICAL GRANULOMA
Intervention Type
Other
Intervention Name(s)
COMMON SALT
Intervention Description
THE USE OF COMMON SALT IN TREATMENT OF UMBILICAL GRANULOMA
Primary Outcome Measure Information:
Title
Comparison Of Doxycycline And Common Salt (TableCooking) For Treatment Of Umbilical Granuloma In Children: A Randomised Control Trial
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion criteria: Neonates and infants (age<1yr) Both genders Confirmed by ultrasonography and sinography (if applicable) Exclusion Criteria: 1. If any treatment is already given 2. Patient lost in follow up 3. Refusal
Facility Information:
Facility Name
Pakistan institute of medical Sciences/ Shaheed Zulfiqar Ali Bhutto Medical University
City
Islamabad
Country
Pakistan

12. IPD Sharing Statement

Learn more about this trial

Comparison Of Doxycycline And Common Salt For Treatment Of Umbilical Granuloma: A Randomised Control Trial

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