The aim of this prospective, randomized clinical trial was to evaluate the effectiveness, safety and tolerability of Fumaria parviflora Lam. (will fumitory) infused aqueous extract on the treatment of infantile colic.
Design
Two arm parallel group randomised trial with blinded postoperative care and blinded outcome assessment
Settings and conduct
49 colicky infants among patients seen at pediatrics department of Khatam Al-Anbia Specialty Clinic were recruited. blinding was applied to patients and statistician
Participants/Inclusion and exclusion criteria
inclusion criteria: 3 to 16 weeks age; cry-fuss behavior that lasted ≥3 hours a day for ≥3 days in the 1 week before enrollment
Exclusion criteria were receiving other drugs for colic treatment and clinical evidence of gastrointestinal disorders or chronic illness
Intervention groups
will fumitory group
simethicone group
Main outcome variables
Primary outcome was intervention success;defined as average crying duration decrease to less than 180 minutes/day (according to Wessel’s criteria). Secondary outcome was the number of respondents in each group at the end of study.Responding was defined as ≥50% reduction in average crying duration.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140817018828N5
Registration date:2018-06-18, 1397/03/28
Registration timing:retrospective
Last update:2018-06-18, 1397/03/28
Update count:0
Registration date
2018-06-18, 1397/03/28
Registrant information
Name
Alimohammad Ranjbar
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3419
Email address
amranjbar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
2017-04-21, 1396/02/01
Actual recruitment end date
2017-12-22, 1396/10/01
Trial completion date
empty
Scientific title
Study of the effect of Fumaria parviflora Lam. aqueous extract versus simethicone on infantile colic
Public title
Effect of will fumitory on infantile colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
3 to 16 weeks age
Cry-fuss behavior that lasted ≥3 hours a day for ≥3 days in the 1 week before enrollment
Exclusion criteria:
Evidence of gastrointestinal disorders or chronic illness
Receiving other drugs for colic treatment
Age
From 21 days old to 120 days old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
52
Actual sample size reached:
49
Randomization (investigator's opinion)
Randomized
Randomization description
Restricted randomization based on random allocation rule where among 52 patients included, 26 were assigned to receive extract by lot and the remaining were assigned to simethicone group.Randomization was concealed in sequentially numbered, sealed, opaque envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients; Statiscian; The author responsible for gathering data
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Ba Honar square
City
Yazd
Province
Yazd
Postal code
8917693571
Approval date
2016-10-16, 1395/07/25
Ethics committee reference number
Ir.ssu.medicine.rec.1395.212
Health conditions studied
1
Description of health condition studied
Infantile colic
ICD-10 code
K20-K31
ICD-10 code description
Diseases of oesophagus, stomach and duodenum
Primary outcomes
1
Description
infant crying duration
Timepoint
before enrollment-day 10 from baseline
Method of measurement
daily diary to assess crying duration
Secondary outcomes
1
Description
number of respondends
Timepoint
day 10 from baseline
Method of measurement
Number of infants who experienced≥50% reduction in average crying duration.
Intervention groups
1
Description
Intervention group: fumitory extract group
Category
Treatment - Drugs
2
Description
Intervention group: simethicone group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam-Al-Anbia multi-specialty clinic
Full name of responsible person
Saeede Ebrahimi
Street address
ShahidTaleghani Blvd
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3733 0122
Email
clinic@ssu.ac.ir
Web page address
http://www.ssu.ac.ir/cms/index.php?id=638
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hooshang Mehrparvar
Street address
Bahonar Square, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3724 0171
Email
ah.mehrparvar@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Alimohamad Ranjbar Jamal abadi
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Professor Hesabi Blvd, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3820 3409
Fax
Email
amranjbar@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mahmood Noori Shadkam
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Yazd, Ba Honar square
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 1724 4551
Email
mahmood7072005@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Saeede Ebrahimi
Position
student of doctorate of pharmacy
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
professor Hesabi Blvd
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 913 354 1255
Email
saeede.ebrahimi1371@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