The effect of standardized ginseng extract on pain and quality of sleep in patients with cancer.
Design
In this study, 80 patients with gastrointestinal and intestinal cancer who are referred to the Shahid Ghazi city of Tabriz are selected. Participants are randomly divided into intervention and control groups and each participant is assigned a code.
Settings and conduct
A double blind clinical trial study performed on cancer survivors referred to the Tabriz Shahid Ghazi Center in 2017-18.Participants will be randomly allocated into two groups of control and intervention using blocking method.Before the intervention, after 28 days, the pain and quality of sleep will be measured.The intervention group received 250 mg of standardized ginsing extract once a day, and was given to the placebo control group once a day.Blinding of the study by placing the drug and placebo in the same packages will be opaque.
Participants/Inclusion and exclusion criteria
Study Participants: Patients with gastric or colorectal cancer who complain of pain / sleep disturbance. Patients with hypertension, diabetes, history of seizures, taking aspirin or warfarin are excluded.
Intervention groups
Standardized Ginseng Extract
Main outcome variables
Reduce pain
Improve sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171015036777N2
Registration date:2018-01-10, 1396/10/20
Registration timing:prospective
Last update:2018-01-10, 1396/10/20
Update count:0
Registration date
2018-01-10, 1396/10/20
Registrant information
Name
Musab Ghaderi
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 937 809 5753
Email address
musab.ghaderi@tbzmedn.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-04, 1396/11/15
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
he effect of ginseng on cancer related pain, and Quality of sleep in cancer survivors: a clinical trial study.
Public title
he effect of ginseng on cancer related pain, and Quality of sleep
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A definitive diagnosis of cancer according to the opinion of the oncologist
Patients who are at stage II and I of the disease.
Patients with colorectal cancer or stomach cancer
Having a sleep disorder
Having pain
Exclusion criteria:
Use of anesthetics and narcotic drugs during study
Participant's unwillingness to continue participating in the study
Mental illness that is mentioned in the medical history of the patient.
Receiving sleep disturbances such as diuretic drugs, antidepressants, inotropes and amphetamines at night
Need for cardiopulmonary resuscitation during the intervention
Mental disabilities
Taking anti-coagulant drugs such as warfarin or aspirin
Having diabetes and receiving anti-diabetes treatment
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is based on quadruple blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to hide the drug with a placebo, the drug will be placed in matte packets in similar envelopes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته منطقه ای اخلاق دانشگاه علوم پزشکی تبریز
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabri
City
Tabriz
Province
East Azarbaijan
Postal code
5165687386
Approval date
2017-12-04, 1396/09/13
Ethics committee reference number
IR.TBZMED.REC.1396.785
Health conditions studied
1
Description of health condition studied
cancer
ICD-10 code
G89.3
ICD-10 code description
Neoplasm related pain (acute) (chronic)
Primary outcomes
1
Description
Pain based on scale vas
Timepoint
Before the intervention, 30 days after the intervention.
Method of measurement
scale VAS
Secondary outcomes
1
Description
Sleep quality based on Pittsburgh scale
Timepoint
Before the intervention, 30 days after the intervention.
Method of measurement
Pittsburgh scale
Intervention groups
1
Description
Intervention group: Standard Jensing Extract 250 mg, Gol daru Factory, once a day
Category
Treatment - Drugs
2
Description
Control group: Capsules of the same color and shape and size with the main drug filled with placebo (wheat flour)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
shahid Ghazi
Full name of responsible person
Azad Rahmani
Street address
Tabriz, Southern Shariati, Faculty of Nursing and Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
999999
Phone
+98 41 3477 6411
Email
Musab.ghaderi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shahid Ghazi Research Center
Street address
Tabriz - University Street - Golgarsh Street, Shahid Ghazi Hospital - Hematology and Oncology Research Center
City
tabriz
Province
East Azarbaijan
Postal code
51665-158
Phone
+98 41 3334 3626
Email
horc_tums@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Azad Rahmani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tabriz, Southern Shariati, Faculty of Nursing and Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
nursing@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Musab Ghaderi
Position
student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Tabriz, Southern Shariati, Faculty of Nursing and Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
musab.ghaderi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
musab ghaderi
Position
student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Tabriz, Southern Shariati, Faculty of Nursing and Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
Musab.ghaderi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data related to the main objectives without mentioning the personal details of individuals
When the data will become available and for how long
Six months after the publication of the article
To whom data/document is available
Individuals who intend to conduct a meta-study study or systematic review.
Under which criteria data/document could be used
In order to conduct a meta-analysis study
From where data/document is obtainable
musab.ghaderi@gmail.com
What processes are involved for a request to access data/document