The aim of the present study was to assess the effect of ginger (Zingiber officinale) extract on salivation and symptoms and signs of xerostomia in patients undergoing head and neck radiotherapy. Patients who had received a radiotherapy dose of more than 45 Grays in the head and neck region at least 6 months previously, without recurrence of the condition, with xerostomia based on Fox questionnaire, were included in the present study on the condition that the cause of xerostomia was not other medical conditions such as diabetes and Sjögren’s syndrome. All the patients gave their informed written consent to be included in the study. Subjects who did not want to participate in the study or did not want to continue for any reason were excluded. A total of 40 subjects were selected from the patients undergoing radiotherapy in the Department of Oncology and Radiotherapy, Golestan Hospital, Ahwaz, Iran, and were asked to fill out the research questionnaire. The salivary flow of the subjects was measured. Forty paper packets were prepared and a code was written on each packet and based on the code, 100 capsules of ginger extract or placebo were placed in each packet. The packets were randomly distributed among the subjects who were asked to take one capsule every 6 hours. After 2 weeks the patients were asked to fill out the questionnaires again. Then their salivary flow was once again measured. A decrease in xerostomia severity and an increase in salivation were the preliminary outcomes of the present research study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013120915723N1
Registration date:2014-04-14, 1393/01/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-14, 1393/01/25
Registrant information
Name
Mohammad Shooriabi
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1336 7562
Email address
sadeghi.d@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology of Ahvaz Jundishapur University of Medical Science under project number mprc-46
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2012-11-20, 1391/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate the effect of ginger extract on salivary secretion in patients with radiation-induced xerostomia (double-blind study - controlled)
Public title
Ginger effect on salivary secretion
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria were:
1- Patients had a history of head and neck cancer and its treatment with high-dose radiotherapy of 45 Gy have been..
2-At least 6 months past the end of radiotherapy patients.
3 - Age above 18 years
4 - confirms xerostomia questionnaire with Fox
5 - to sign a consent form inclusion
Criteria excluded :
1 - Pregnancy
2 - Patients with more than 3 months has passed from cancer treatment.
3 - Patients who can not take food by mouth.
4 - Radiation therapy to patients who have not received their full.
5 - Patients with Sjogren's syndrome or other causes of dry mouth (except radiation) are.
Exclusion criteria were:
1 - pregnancy during the study
2 - Sensitivity Ginger.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Postal code
Approval date
2013-04-13, 1392/01/24
Ethics committee reference number
ajums.REC.1392.41
Health conditions studied
1
Description of health condition studied
Xerostomia
ICD-10 code
K11.7
ICD-10 code description
Disturbances of salivary secretion
Primary outcomes
1
Description
Xerostomia
Timepoint
Beginning of the study, two weeks after baseline (end of study)
Method of measurement
Questionnaire
2
Description
Weight of unstimulation saliva
Timepoint
Beginning of the study, two weeks after baseline (end of study)
Method of measurement
Milligrams
Secondary outcomes
1
Description
Improved quality of life
Timepoint
Beginning of the study two weeks after baseline (end of study)
Method of measurement
Questionnaire
Intervention groups
1
Description
Ginger capsules, 500 mg orally four times daily for two weeks.
Category
Treatment - Drugs
2
Description
Starch capsules, 500 mg orally four times daily for two weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Docter Shooriabi
Street address
Golestan St.
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mohammad Shooriabi
Street address
Vice Chancellor for Research and Technological Development,Ahvaz Jundishapur University of Medical Sciences
City
ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mohammad Shooriabi
Position
Faculty member
Other areas of specialty/work
Street address
Department of Oral Medicine, School of Dentistry, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
6193959883
Phone
+98 61 1320 5169
Fax
+98 98611325168
Email
dsshoriabii@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mohamad Shooriabi
Position
Phd
Other areas of specialty/work
Street address
Faculty of Dentistry
City
Ahvaz
Postal code
6193959883
Phone
+98 61109153529426
Fax
+98 61 1320 5168
Email
dsshoriabii@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mohamad Shooriabi
Position
Faculty member
Other areas of specialty/work
Street address
Faculty of Dentistry, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
00986113205168
Phone
+98 61 1320 5169
Fax
Email
dsshoriabii@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)