In this study, effect of chamomile syrup on prevention of chemotherapy induced neutropenia in pediatric ALL patients will be investigated through a randomized triple blind placebo controlled clinical trial. Main inclusion criterion is 2-18 years old children with ALL B cell admitted in hospital, while those with sensitivity to chamomile will be excluded. A total number 36 participants in each group will receive 2.5 cc of either chamomile syrup or placebo once daily for 30 days. Their white blood cell count, absolute neotrophil count, and quality of life will be measured before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013021612486N1
Registration date:2017-05-30, 1396/03/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-30, 1396/03/09
Registrant information
Name
Babak Daneshfard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2712 8867
Email address
daneshfard@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of chamomile syrup oral application in prevention of chemotherapy-induced neutropenia in pediatric ALL patients
Public title
Effect of chamomile syrup on acute leukemia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Pediatric (2-18 years old) ALL B cell patients admitted in Shiraz Amir hospital ; Signing written informed consent; Non-usage of any other herbal therapies. Exclusion Criteria: Sensitivity to chamomile; Refuse to cooperate
Age
From 2 years old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand
City
Shiraz
Postal code
7134845794
Approval date
2017-04-17, 1396/01/28
Ethics committee reference number
IR.SUMS.REC.1396.11
Health conditions studied
1
Description of health condition studied
Acute Lymphoblastic Leukemia (ALL)
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukaemia [ALL]
Primary outcomes
1
Description
GCSF consumption
Timepoint
before and after the intervention
Method of measurement
Checking hospital documents
2
Description
Absolute Neutrophil Count (ANC)
Timepoint
before, during, and after the intervention
Method of measurement
Calculation according to the white blood cell count and neutrophil percentage
Secondary outcomes
1
Description
Quality of life
Timepoint
before and after the intervention
Method of measurement
Standard questionnaire
2
Description
Hospital course duration
Timepoint
after the intervention
Method of measurement
Hospital documents
Intervention groups
1
Description
Daily 2.5 cc chamomile syrup orally for 30 days in the intervention group
Category
Prevention
2
Description
Daily 2.5 cc placebo syrup orally for 30 days in the control group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Oncology Hospital
Full name of responsible person
Babak Daneshfard
Street address
7th Floor- Building No 2-Medical School-Setad Sq.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Deputy of Research
Street address
7th Floor-Central Building of University-Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Babak Daneshfard
Position
MD, PhDc in Traditional Persian Medicine
Other areas of specialty/work
Street address
7th Floor- Building No 2-Medical School-Setad Sq.
City
Shiraz
Postal code
7134845794
Phone
+98 71 3234 5145
Fax
+98 71 3234 5145
Email
babakdaneshfard@gmail.comdaneshfard@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Babak Daneshfard
Position
MD, PhDc in Traditional Persian Medicine
Other areas of specialty/work
Street address
7th Floor- Building No 2-Medical School-Setad Sq.
City
Shiraz
Postal code
7134845794
Phone
+98 71 3234 5145
Fax
+98 71 3234 5145
Email
babakdaneshfard@gmail.comdaneshfard@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Babak Daneshfard
Position
MD, PhDc in Traditional Persian Medicine
Other areas of specialty/work
Street address
7th Floor- Building No 2-Medical School-Setad Sq.
City
Shiraz
Postal code
7134845794
Phone
+98 71 3234 5145
Fax
+98 71 3234 5145
Email
babakdaneshfard@gmail.comdaneshfard@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)