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The effect of ginseng on cancer related fatigue and Quality of life in cancer survivors: a randomized controlled clinical trial study

Protocol summary

Summary
Fatigue is one of the most common problems in cancer patients. This problem can affect the quality of life of these people.By choosing the appropriate method, patients 'problems can be cured and patients' quality of life can be increased.Among different methods, the use of herbal medicines has been considered by many researchers.One of the famous medicinal herbs mentioned in various articles is ginseng. The aim of this study was to investigate the effect of ginseng on fatigue and quality of life in cancer patients. This study is a double-blind, randomized, controlled clinical trial.Study population: Cancer survivors referring to Shahid Ghazi Tabriz center and the time of study in 2017-2018. The inclusion criteria included diagnosed cancer (colorectal, stomach) According to the oncologist, the patient's consciousness, lack of mental and brain illness in the patient's medical history indicated.Fatigue score above 4 (maximum score 10), aged 65-18 years, patients at stage II and I of the disease.Exclusion criteria: a disturbing sleep medications such as diuretic drugs, antidepressants, and amphetamine inotrope at night, have a history of blood pressure in patients taking anticoagulant drugs (aspirin and heparin), Diabetes. Study tools: Brief Fatigue Inventory (BFI) and the standard quality of life-related cancer tool (EORTC QLQ-C30 (version 3). Method of intervention: Participants will be randomly assigned to the intervention and control groups using a four-way blocking method. The study is double-blind. patients and researchers are unaware of what medicine and placebo are. Boxes will be encoded by someone who is not involved in the sampling. The intervention group received 250 mg daily ginseng capsules, and was given to the placebo control group. Pre-test samples are taken before intervention begins.The medication / placebo will be for 28 days. 28 days after the intervention, the post-test will be taken. Then, by using SPSS V.14 software, descriptive and analytical tests will examine the study objectives.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017101536777N1
Registration date: 2017-10-25, 1396/08/03
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-10-25, 1396/08/03
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
Tabriz university of medical sciences
Expected recruitment start date
2017-11-06, 1396/08/15
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ginseng on cancer related fatigue and Quality of life in cancer survivors: a randomized controlled clinical trial study
Public title
The effect of ginseng on cancer related fatigue and Quality of life in cancer survivors
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: A definitive diagnosis of cancer according to the opinion of the oncologist Fatigue score above 4 (out of 10) Aged 65-18 years Patients in stage II, I disease. Patients with colorectal , stomach cancer Not having hypertension Not having diabetes Exclusion criteria: Get the anesthetic and narcotic drugs during the study The patient's unwillingness to continue participating in the study Occurrence of acute problems during the study The existence of mental and brain illness in the patient's medical history indicated. Receiving sleep disturbances such as diuretics, antidepressants, inotropes and amphetamines at night Need for cardiopulmonary resuscitation during intervention Pregnant and lactating women Receive oral antidiabetic medicines Coagulation therapy (aspirin, heparin) Having a history of seizure
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Tabriz university of medical science
Street address
East Azerbaijan Province, Tabriz, Univesity Main St
City
Tabriz
Postal code
Approval date
2017-07-23, 1396/05/01
Ethics committee reference number
iR.TBZMED.REC.1396.345

Health conditions studied

1

Description of health condition studied
Cancer
ICD-10 code
c80.9
ICD-10 code description
c80.9

Primary outcomes

1

Description
fatigue
Timepoint
before intervention, once month after intervention
Method of measurement
Brief Fatigue Inventory (BFI)

Secondary outcomes

1

Description
quality of life
Timepoint
before intervention, once month after intervention
Method of measurement
EORTC QLQ-C30 (version 3)

Intervention groups

1

Description
In this study, standardized ginseng extract was given to patients in 250 mg capsules daily for four weeks. In order to hide the drug with placebo in similar envelopes, they will be put in matte pack. Assignment and sequencing of allocation and preparation of packets containing ginsing with placebo will be done by a person not involved in the sampling and analysis of the data by numbering on sub-boxes.
Category
Treatment - Drugs

2

Description
In this study, Placebo capsules same as the original medicine, patients are given daily for four weeks. In order to hide the drug with placebo in similar envelopes, they will be put in matte pack. The assignment and sequencing of the envelopes containing Jensing with Placeco by a non-person involved in the sampling and analysis of the data will be done by numbering the sub-boxes.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghazi Tabatabaee Hospital Tabriz
Full name of responsible person
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences, Tabriz Faculty of Nursing and Midwifery
Full name of responsible person
Musab.ghaderi
Street address
South Shariati St., Faculty of Nursing and Midwifery, Tabriz
City
Tabriz
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, Tabriz Faculty of Nursing and Midwifery
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
Tabriz University of Medical Sciences, Tabriz Faculty of Nursing and Midwifery
Full name of responsible person
Musab ghaderi
Position
student
Other areas of specialty/work
Street address
South Shariati St., Faculty of Nursing and Midwifery, Tabriz
City
Tabriz
Postal code
Phone
+98 937 809 5753
Fax
Email
musab.ghaderi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz uni of medical science
Full name of responsible person
Azad rahmani
Position
Associate Professor
Other areas of specialty/work
Street address
South Shariati St., Faculty of Nursing and Midwifery, Tabriz
City
Tabriz
Postal code
Phone
+41 34799946
Fax
Email
azad.rahmani@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences, Tabriz Faculty of Nursing and Midwifery
Full name of responsible person
Musab ghaderi
Position
student
Other areas of specialty/work
Street address
South Shariati St., Faculty of Nursing and Midwifery, Tabriz
City
tabriz
Postal code
Phone
+98 937 809 5753
Fax
Email
musab.ghaderi@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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