The efficacy of topical Chamomile oil, an Iranian traditional medicine, compared with placebo on recovery of bowel function following cesarean: a randomized controlled trial
The aim of this study is evaluation of the effect of Topical chamomile on reduction of ileus after cesarean section. The population of this study is women candidates of cesarean section in gynecological hospital of Mirza Khogek khan in Tehran and in Mobini hospital of sabzevar.
In this study 150 samples will be enrolled after approval of ethics committee and informed consent form. After surgery samples were randomly allocated to the intervention group (Topical application of chamomile oil) and placebo group (receiving sesame oil) and control group (routine treatment). A questionnaire is completed on demographic characteristics and objectives of study for each of the participants. In the intervention group 15 drops of chamomile oil will be applied on abdominal region immediately after consciousness every half hour in the first hour. The second to the fourth hour, every hour, then every 8 hours until discharges time. With same method, placebo group received sesame oil. Routine care is for all three groups. Data collection is included interviews, questionnaires and examination. The Time of bowel movement, flatus and defecation, feeling of hunger is noted. The data collected are analyzed by statistical analysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014082818951N1
Registration date:2014-11-12, 1393/08/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-11-12, 1393/08/21
Registrant information
Name
Fereshteh Ghorat
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5558 0386
Email address
f-ghorat@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical sciences
Expected recruitment start date
2015-01-20, 1393/10/30
Expected recruitment end date
2015-08-22, 1394/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of topical Chamomile oil, an Iranian traditional medicine, compared with placebo on recovery of bowel function following cesarean: a randomized controlled trial
Public title
The efficacy of Chamomile on recovery of bowel function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Pregnant women undergoing cesarean section; a minimum age of 18 years and maximum 35 years; gestational age 42-38 weeks; .starvation at least 8 hours before surgery; Stable vital signs; consent for participation in the study.
Exclusion criteria: epidural anesthesia; a vertical incision in the abdomen and uterus to surgery; history of previous abdominal surgery other than cesarean; history of chronic inflammatory bowel disease and gastrointestinal disease; intraoperative complications (severe adhesions and manipulation of the bowel;blood transfusions, damage to the bowel and bladder); postoperative complications (atonic uterus, infection Academy); blood transfusions during or after surgery; length of surgery more than 90 minutes; the skin lesion at the site of the study; medical and obstetric disorders (thyroid disease, severe digestive disorders, diabetes, pre eclampsia); received narcotic analgesic more than one dose (1mg / kg); smoking and addiction; refuse of the patient from the study
Age
From 16 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Enghelab street, Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2015-01-28, 1393/11/08
Ethics committee reference number
134808
Health conditions studied
1
Description of health condition studied
Ileus
ICD-10 code
K56.0
ICD-10 code description
Paralytic ileus
Primary outcomes
1
Description
Time to first flatus after surgery
Timepoint
Every three hour
Method of measurement
Reported by the patient
Secondary outcomes
1
Description
Bowel sound
Timepoint
Every 3 hour
Method of measurement
Stethoscope
2
Description
Time of defication
Timepoint
Every 3 hour
Method of measurement
Reported by the patient
3
Description
Time to start diet
Timepoint
Every 3 hour
Method of measurement
The patient's medical records
Intervention groups
1
Description
In the intervention group 15 drops of chamomile oil will be applied on abdominal region immediately after consciousness every
half hour in the first hour. The second to the fourth hour, every hour, then every 8 hour until discharge time.
Category
Treatment - Drugs
2
Description
In the placebo group 15 drops of Sesame Oil will be applied on abdominal region immediately after consciousness every half hour in the first hour. The second to the fourth hour, every hour, then every 8 hours until discharge time.
Category
Treatment - Drugs
3
Description
Control patients receive routine care
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecological Hospital of Mirza Khogek Khan
Full name of responsible person
Fereshteh Ghorat
Street address
Valiasr Square, Karimkhan Street, Vila Street
City
Tehran
2
Recruitment center
Name of recruitment center
Mobini Hospital
Full name of responsible person
Fereshteh Ghorat
Street address
Kashefi Street
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mis Roja Rahimi
Street address
Tehran University of Medical Sciences, School of Traditional Medicine
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Traditional Medicine. Tehran University of Medical Sciences
Full name of responsible person
Fereshteh Ghorat
Position
PHD Student in Traditional Medicine
Other areas of specialty/work
Street address
School of Traditional Medicine. Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 51 4464 1144
Fax
Email
f-ghorat@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Traditional Medicine. Tehran University of Medical Sciences
Full name of responsible person
Ebrahim Khadem Azghandi
Position
Assistant Professor in Traditional Medicine
Other areas of specialty/work
Street address
School of Traditional Medicine. Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 51 4464 1144
Fax
Email
dr.ebrahim khadem@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Traditional Medicine Tehran University of Medical Sciences
Full name of responsible person
Fereshteh Ghorat
Position
PHD Student in Traditional Medicine
Other areas of specialty/work
Street address
School of Traditional Medicine, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 51 4464 1144
Fax
Email
f-ghorat@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)