Effects of an herbal supplement containing Allium sativum, Panax ginseng, Curcuma longa and green tea on quality of life in patients with common upper gastrointestinal cancers
Objective: Evaluating the effects of an herbal supplement containing Allium sativum, Panax ginseng, Curcuma longa and green tea on quality of life in patients with common upper gastrointestinal cancers.
Inclusion criteria: Patients with cancer of esophagus or stomach, normal liver enzymes, and creatinine less than 1.5 mg/dl.
Exclusion criteria: Patients with severe complication of cancer and Induction of toxicity by the herbal supplement.
Population and sample size: This randomized clinical trial will perform on 60 patients with cancer of esophagus or stomach who received adjuvant therapy.
Intervention: Patients are randomly divided into 2 groups: (1) treatment group which received syrup (30 ml, three times daily) containing the polyherbal supplement for 60 days, and (2) control group which received the same dose of placebo syrup (sacarose 70%) for 60 days. All subjects in two groups also continuously received their standard cancer therapy.
Primary outcome measure: Quality of life is determined before and after treatment using a standard questioner.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017030416776N2
Registration date:2017-09-20, 1396/06/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-20, 1396/06/29
Registrant information
Name
Ahmad Ghorbani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1800 2262
Email address
ghorbania@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2017-03-20, 1395/12/30
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of an herbal supplement containing Allium sativum, Panax ginseng, Curcuma longa and green tea on quality of life in patients with common upper gastrointestinal cancers
Public title
Effects of an herbal supplement on quality of life in patients with gastrointestinal cancers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with cancers of esophagus or stomach; Normal liver enzymes; Hb more than 9 g/dL; Platelet more than 100000; Creatinine less than 1.5 mg/dl.
Exclusion criteria: Patients with severe complication of cancer; Induction of toxicity by the herbal supplement; Pregnancy; Consumption of anticoagulant drugs
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Mashhad University of Medical Sciences
Street address
Ghoreishi Building, Daneshgah Street
City
Mashhad
Postal code
9177948564
Approval date
2016-01-02, 1394/10/12
Ethics committee reference number
IR.MUMS.REC.1394.598
Health conditions studied
1
Description of health condition studied
Cancers of oesophagus and stomach
ICD-10 code
C15.9 and
ICD-10 code description
Oesophagus, unspecified; Stomach, unspecified
Primary outcomes
1
Description
quality of life
Timepoint
30 days and 60 days after beginning of study
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Patients in control group are given placebo solution (sacarose 65%) 20 cc three times a day for 60 consecutive days. All subjects will receive conventional treatments for cancer.
Category
Placebo
2
Description
Patients in intervention group are given polyherbal solution (containing extracts of garlic, green tea and Curcuma longa and powder of Panax ginseng) 20 cc three times a day for 60 consecutive days. All subjects will receive conventional treatments for cancer.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad University of Medical Sciences
Full name of responsible person
Dr Azar Fani Pakdel
Street address
Oncology Department, Emam-Reza Hospital, Ebne-Sina Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Saeed Eslami
Street address
Ghoreyshi Building, Daneshgah Street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Ahmad Ghorbani
Position
Ph.d. in Physiology, Research Associate Professor
Other areas of specialty/work
Street address
Faculty of Medicine, Azadi Square
City
Mashhad
Postal code
Phone
+98 51 3800 2256
Fax
Email
ghorbania@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Azar Fani Pakdel
Position
Oncologist, Assistant Professor
Other areas of specialty/work
Street address
Oncology Department, Emam-Reza Hospital, Ebn_Sina Street
City
Mashhad
Postal code
Phone
+98 51338543031
Fax
Email
FaniPA@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Dr. Ahmad Ghorbani
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
ghorbania@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)