The present study is double-blinded intervention and clinical trial which is aimed at investigating the effects of Apium graveolens L.fruit on neuropathy resulted from chemotherapy with folfox in patients with colorectal cancer. 66 patients within the range of 20 to 80 years old were selected and were randomly divided into two groups. The patients were included in the study upon their own satisfaction and according to study entrance and exit criteria and normality of monofilament test so that we made sure they were not suffering from neuropathy. Patients in main group received standardized capsules containing in Apium graveolens L.fruit for 12 courses daily with 8h spans. They were informed of consumption instructions and time. Patients were closely observed in each of the twelve courses. The control group, on the other hand, underwent the same process except that the capsules received by the patients in this group contained cellulose. Finally the results were compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017030818828N2
Registration date:2017-04-18, 1396/01/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-04-18, 1396/01/29
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
Yazd University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of Apium graveolens l.fruit effect on folfox induced neuropathy in patient with colorectal cancer.
Public title
Determination of Apium graveolens l.fruit effect in patient with colorectal cancer.
Purpose
Treatment
Inclusion/Exclusion criteria
Enclusion criteria:
Patient must be suffering from colorectal cancer; Patient must be between 20 to 80 years old; The patient must have received folfox diet containing folinic acid; 5-fluro uracil and oxaliplatin; Full satisfaction of the patient
Exclusion criteria:
Patients who take acupuncture during their treatment; Patients who receive massage therapy during their treatment; Patients who receive physiotherapy during their treatment; Patients who take indigenous medicine; Patients with previously-diagnosed neuropathy; Patients with lupus or rheumatoid arteritis; Patients with other forms of cancer
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yazd University of Medical Sciences
Street address
Talar honar alley, Bahonar square, Yazd, Iran
City
Yazd
Postal code
8917693571
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.SSU.REC.1395.69
Health conditions studied
1
Description of health condition studied
colorectal cancer
ICD-10 code
C18
ICD-10 code description
Malignant neoplasm of colon
Primary outcomes
1
Description
The pain
Timepoint
Beforetreatment, 5 to 6 months after treatment
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Patients in main group received standardized capsules containing in Apium graveolens L.fruit for 12 courses daily with 8h spans. They were informed of consumption instructions and time. Patients were closely observed in each of the twelve courses.
Category
Treatment - Drugs
2
Description
Patients in main group received standardized capsules containing in cellulose for 12 courses daily with 8h spans. They were informed of consumption instructions and time.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd University of Medical Sciences
Full name of responsible person
Masoud Kalami Yazdi
Street address
Yazd, Iran
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Science
Full name of responsible person
Hooshang Mehrparvar
Street address
Bahonar Square, Yazd, Iran
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Science
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
Yazd University of Medical Sciences
Full name of responsible person
Alimohamad Ranjbar Jamal abadi
Position
PhD
Other areas of specialty/work
Street address
Professor Hesabi Boolvar, Yazd, Iran
City
Yazd
Postal code
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 Science
Full name of responsible person
Mohamadreza Mortazavizadeh
Position
Oncologist, Assistant Professor
Other areas of specialty/work
Street address
Professor Hesabi Boolvar, Yazd, Iran
City
Yazd
Postal code
Phone
+98 35 3820 3409
Fax
Email
mortazavizadeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Science
Full name of responsible person
Amir Mohammad Safavi
Position
Student Doctor of Pharmacy
Other areas of specialty/work
Street address
Professor Hesabi Boolvar, Yazd, Iran
City
Yazd
Postal code
Phone
+98 35 3820 3409
Fax
Email
safavi.amir@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)