Using herbal compounds to chemical agents have less side effects and it is easier for patients to tolerate them.
Design
A randomized, double-blind, placebo controlled clinical trial (phase 3) with a total sample of 60 cases of cancer patients receiving chemotherapy drugs
1- A group of 20 treatment recipients receiving saffron tablets daily for a period of 3 months
2-A 20-person control group receiving a placebo per day for a period of 3 months
3. A group of 20 positive controls that receive gabapentin daily for a period of 3 months
Settings and conduct
The location of the study will be at the Kowsar Hospital of Semnan (and if necessary, other medical centers). Cancer patients who receive chemotherapy drugs are selected through a physician's history and physical examination, those who show signs of neuropathy and will be included in the study if approved. And then divided into the above mentioned groups and the mentioned protocols will be applied to them. The severity of their neuropathy symptoms will be measured by a questionnaire. In this double-blind study, both prescriber and patients will be unaware of the type of drug used.
Participants/Inclusion and exclusion criteria
Input: All cancer patients who show signs of neuropathy due to chemotherapy
No entry: Cancer patients who have neuropathy due to factors other than chemotherapy, Pregnants and nursing mothersو People who receive sedatives such as morphine etc
Intervention groups
1- Treatment group receiving saffron tablets
2_ Control group receiving placebo
3. Positive control group receiving gabapentin
Main outcome variables
Severity of neuropathy (based on items in the questionnaire) of patients receiving chemotherapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180119038433N1
Registration date:2018-12-28, 1397/10/07
Registration timing:registered_while_recruiting
Last update:2018-12-28, 1397/10/07
Update count:0
Registration date
2018-12-28, 1397/10/07
Registrant information
Name
Amin Izadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3346 5228
Email address
aminizadi1374@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Crocus sativus L. (saffron) on patients with chemotherapy-induced neuropathy; A clinical trial
Public title
The effect of saffron on patients with chemotherapy-induced neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chemotherapy-induced neuropathy
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is a simple, individual and by random numbers
Accidental assignment to intervention and control groups
Blinding (investigator's opinion)
Double blinded
Blinding description
Medications will be coded by a third person (outside the study) (e.g., the main treatment group number 1, placebo # 2, and positive control # 3). Then the stickers of the medications are removed and the number of drugs will be available to the student (responsible for the correct follow-up and administration of the medications). Student sees only the number and does not know the type of medicine. The patient merely knows that she will be given a study that will help her treatment and is completely unaware of the prescription of the drug. After administering the drugs and registering the data by the student, the information is provided to the statistical analyst (which he knows only the number and does not know the type of medication). After statistical analysis, the data will be available to the researcher responsible for writing the article. In order to write the article, the main researcher will also use the third person (outside the study) to match the type of medication
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Semnan University of Medical Sciences
Street address
Damghan road-Semnan University of Medical Sciences
City
semnan
Province
Semnan
Postal code
3519899951
Approval date
2018-11-20, 1397/08/29
Ethics committee reference number
IR.SEMUMS.REC.1397.195
Health conditions studied
1
Description of health condition studied
Chemotherapy-induced nephropathy
ICD-10 code
G62.0
ICD-10 code description
Drug-induced polyneuropathy
Primary outcomes
1
Description
Severity of neuropathy (based on items in the questionnaire) of patients receiving chemotherapy
Timepoint
Evaluation of neuropathy in patients before administration of medication is between the administration period (day 45 after the intervention, ie the administration of the first dose, placebo and positive control) and after treatment (up to 1 month after the last administration of the intervention).
Method of measurement
Nerve conduction velocity test as well as questionnaire
Secondary outcomes
1
Description
Life quality Score
Timepoint
Prior to prescribing, between the administration period (45 days after the intervention, ie the administration of the first dose, placebo and positive control) and after treatment (up to 1 month after the last administration of the interventions)
Method of measurement
Short questionnaire 12 questions (SF12)
Intervention groups
1
Description
Patients with chemotherapy-induced neuropathy receiving a 15 mg tablet of saffron (crocin) daily up to 3 months (produced by Mashhad University of Medical Sciences)
Category
Treatment - Drugs
2
Description
Control group: Patients with chemotherapy-induced neuropathy receiving 1 placebo tablet per day for 3 months
Category
Placebo
3
Description
Control group: Patients with chemotherapy-induced neuropathy receiving a 100 mg capsule of gabapentin daily for 3 months (positive control group)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Semnan kosar hospital
Full name of responsible person
Farshid farivar
Street address
Amin highway
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2001
Email
farfarivar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz kokhaei
Street address
Bassij Blvd, Semnan University of Medical Sciences, Deputy of Research, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3344 0225
Email
p_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Hooman bozorgi
Position
Assistant professor-faculty
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Damghan road-Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2001
Email
hoomanbozorgi@semums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hooman bozorgi
Position
Assistant professor-faculty
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Damghan road-Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2001
Email
hoomanbozorgi@semums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hooman bozorgi
Position
Assistant professor-faculty
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Damghan road-Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2001
Email
hoomanbozorgi@semums.ac.ir
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