1. Home
  2. Approved trials
  3. » فارسی

Comparing the Effects of Bathing with Cichorium intybus and Fumaria officinalis Water Extracts on the Icter Neonates

Protocol summary

Study aim
Comparing the Effects of Bathing with Cichorium intybus and Fumaria officinalis Water Extracts on the Icter Neonates
Design
A clinical trial with the control and intervention groups, with factorial groups, double-blind, randomized, phase 2-3 on 93 patients. A block randomization method was used for randomization.
Settings and conduct
After receiving the code of ethics and introduction letter, 93 Neonates from the neonatal department of Shahid Rahimi Medical Education Center in Khorramabad who are eligible to enter the study will be selected and divided into three intervention and control groups of 31 people (two intervention and one control).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Parents' willingness to participate in the study, the gestational age of the baby is 37 to 42 weeks, term babies with a weight of 2500 to 4000 grams without problems except for icter, Apgar 8 to 10 at birth, lactation and the onset of Icter after the second day, total serum bilirubin 14 to 20 mg/dL, the incidence of Icter in babies between 2 and 7 days, and hematocrit percentage greater than 65% or hemoglobin greater than 20. Non-entry criteria: congenital malformation or infection, need for blood transfusion, blood group incompatibility in baby and mother, having a history of skin allergies in the family, and hemolytic icter.
Intervention groups
The control group (with 31 neonates) received only phototherapy. The intervention groups (each with 31 neonates) will receive phototherapy and Bathing with Cichorium intybus and Fumaria officinalis extracts. The intervention will be done by washing from the face to the neck, especially the area behind the ears, chest and upper limbs, abdomen, lower limbs, and back.
Main outcome variables
Icter

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220706055388N2
Registration date: 2023-06-27, 1402/04/06
Registration timing: registered_while_recruiting

Last update: 2023-06-27, 1402/04/06
Update count: 0
Registration date
2023-06-27, 1402/04/06
Registrant information
Name
Hanieh Goodarzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 4261 0119
Email address
h.goodarzi100@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-26, 1402/04/05
Expected recruitment end date
2023-10-27, 1402/08/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effects of Bathing with Cichorium intybus and Fumaria officinalis Water Extracts on the Icter Neonates
Public title
Comparison of the effects of Bathing with Cichorium intybus and Fumaria Officinalis on Icter
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Parents' willingness to participate in the study The gestational age of the neonate is 37 to 42 weeks Term babies weighing 2500 to 4000 grams without problems except for icter Apgar 8 to 10 at birth Breastfeeding and the onset of jaundice after the second da Total serum bilirubin 14 to 20 mg/dL The occurrence of jaundice in babies between days 2 and 7 Hematocrit percentage greater than 65% or hemoglobin greater than 20
Exclusion criteria:
Congenital malformation or infection Need for blood transfusion Blood group incompatibility in baby and mother Having a history of skin allergy in the family Hemolytic icter
Age
From 2 days old to 7 days old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 93
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of samples in groups will be done using the random block method. To equalize the distribution of the confounding variables of gender, birth weight, and gestational age, first classes based on these variables are described as girl/boy, weight less than 2500 grams/weight more than 2500 grams, and gestational age less than 37 weeks/37 weeks and above, and then they are balanced in the studied groups by the random block method. After that, they are divided into three groups (one control group and two intervention groups) in a simple random manner using a table of random numbers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Khorramabad University of Medical Sciences ethics committee
Street address
No. 75, Azadi Alley, Palestine Cinema Alley, Ayatollah Kashani Street
City
Borujerd
Province
Lorestan
Postal code
6913718599
Approval date
2023-01-18, 1401/10/28
Ethics committee reference number
IR.LUMS.REC.1401.301

Health conditions studied

1

Description of health condition studied
jaundice
ICD-10 code
P59.8
ICD-10 code description
Neonatal jaundice from other specified causes

Primary outcomes

1

Description
Blood bilirubin level
Timepoint
Before the intervention, 24 and 48 hours after the intervention
Method of measurement
Arterial blood sample and sent to the laboratory

Secondary outcomes

empty

Intervention groups

1

Description
First Intervention Group: This group will receive both phototherapy and bathing with Cichorium intybus extract. These Neonates were treated with sterile cotton before starting phototherapy and then for 2 days, once a day, after feeding at noon when phototherapy is stopped for health care and other cases, with 250 ml of Cichorium intybus extract. They bathe for 5 to 7 minutes. The room temperature is set at 24-28 degrees Celsius. Cichorium intybus extract is also heated to a temperature of 37.5 degrees Celsius. (Cichorium intybus refers to the aqueous extract of the leaves of this plant. The preparation of the aqueous extract of this medicinal plant is done daily in the laboratory in accordance with the principles of extraction by the pharmaceutical chemist under the supervision of the project's pharmacist. 50 grams of ground Cichorium intybus in 250 cc of water The distillate is soaked at laboratory temperature for 72 hours away from sunlight. Then it is smoothed with Whatman filter paper and prepared for intervention in disposable bottles with a capacity of half a liter. The extracts are stored in the treatment room of the hospital wards at temperature properly maintained and used on a daily basis).
Category
Treatment - Drugs

2

Description
Second Intervention Group: This group will receive both phototherapy and bathing with Fumaria officinalis extract. These Neonates were first hospitalized using sterile cotton before starting phototherapy and then for 2 days, once a day, after feeding at noon, when phototherapy is stopped for health care and other cases, with 250 ml of Fumaria officinalis extract. They bathe for 5 to 7 minutes. The room temperature is set at 24-28 degrees Celsius. Fumaria officinalis refers to the aqueous extract of the leaves of this plant. The preparation of the aqueous extract of this medicinal plant is done daily in the laboratory by following the principles of extraction by a pharmaceutical chemist under the supervision of a project pharmacist. It is dried at room temperature and away from direct sunlight and is ground into powder using a mill. The powder obtained from Fumaria officinalis leaves is mixed with distilled water in a ratio of 1 to 9 (50 grams of powder in 450 cc of distilled water) and boiled for 10 to 15 minutes. Then the extract is filtered using Whatman paper and stored in colored glass until consumption.
Category
Treatment - Drugs

3

Description
Control Group: This group receives only phototherapy (single, double and intense). Being single, double and severe also depends on the Neonate's bilirubin level. Thus, the high bilirubin level receives a severe type. Before starting phototherapy, all Neonates are examined for Coombs, glucose-6-phosphate dehydrogenase, total and direct bilirubin levels, and mother's and Neonate's Rh blood group.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rahimi hospital
Full name of responsible person
Mansoureh Yousefian
Street address
Not Reaching Safavi Bridge., Mujahideen Ave., Azadi Square
City
Khorramabad
Province
Lorestan
Postal code
6813816314
Phone
+98 66 3333 6150
Email
rahimi@hospital.com
Web page address
http://hrgt.lums.ac.ir/tc

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Dr. Bahram Rasoulian
Street address
Zip code: 6813833946, Lorestan University of Medical Sciences Campus Complex, Anoushirvan Rezaei Sq, Moallem Ave, Khorram Abad, Iran
City
Khorram Abad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 0661
Email
publicrelation@lums.ac.ir
Web page address
http://www.lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Khoram Abad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Hanieh Goodarzi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 75, Azadi Alley, Cinema Felestin Alley, Ayatollah Kashani Ave
City
Borujerd
Province
Lorestan
Postal code
6913718599
Phone
+98 66 4261 0119
Email
h.goodarzi100@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Hanieh Goodarzi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 75, Azadi Alley, Cinema Felestin Alley, Ayatollah Kashani Ave
City
Borujerd
Province
Lorestan
Postal code
6913718599
Phone
+98 66 4261 0119
Email
h.goodarzi100@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Hanieh Goodarzi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 75, Azadi Alley, Cinema Felestin Alley, Ayatollah Kashani Ave
City
Borujerd
Province
Lorestan
Postal code
6913718599
Phone
+98 66 4261 0119
Email
h.goodarzi100@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...