The aim of our study was to evaluate the clinical efficacy of ginger capsule (Zintoma herbal capsule) in the relief of symptoms in patients with post-radiotherapy xerostomia. Sixty one subjects were selected from patients with xerostomia of Imam Khomeini Cancer Institute. The patients received ginger capsule or placebo three times daily over a 2 weeks period. Our primary outcome was improvement of xerostomia. Xerostomia was measured through a 100-score visual analogue scale at the baseline and 14 days after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138807012227N2
Registration date:2009-11-28, 1388/09/07
Registration timing:na
Last update:
Update count:0
Registration date
2009-11-28, 1388/09/07
Registrant information
Name
Arezoo Alaie
Name of organization / entity
Kerman dental school
Country
Iran (Islamic Republic of)
Phone
+98 0983412119021
Email address
g_chamani@kmu.ac.ir
Recruitment status
Not enough for processing
Funding source
Kerman Neuroscience Research Center, Kerman University of Medical Sciences, Kerman, Iran
Expected recruitment start date
2008-07-20, 1387/04/30
Expected recruitment end date
2006-10-27, 1385/08/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of systemic effects of ginger on salivation in patients with post-radiotherapy xerostomia.
Public title
Assessment of systemic effects of ginger on salivation in patients with post-radiotherapy xerostomia.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of Xerostomia, age more than 18 years old
Exclusion criteria: Age less than 18 years, smoking, consumption of anticoagulants or Nifedipine, presence of Sjogren syndrome, diabetes mellitus, or end stage cancer, pregnancy, radiotherapy within 3 months prior to study
Age
From 18 years old to 65 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
61
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
Ethics committee of Kerman University of Medical Sciences
Street address
Kerman Neuroscience Research Center, Kerman University of Medical Sciences,Tahmasb abad cross, Kerman, Iran
City
Kerman
Postal code
Approval date
empty
Ethics committee reference number
ک/87/103
Health conditions studied
1
Description of health condition studied
xerostomia
ICD-10 code
k11.7
ICD-10 code description
Disturbance of salivary secretion
Primary outcomes
1
Description
Improvement of xerostomia
Timepoint
After two weeks
Method of measurement
questionnaire
Secondary outcomes
1
Description
improvement of symptom such as chewing, swallowing, speaking
Timepoint
After two weeks
Method of measurement
questionnaire
Intervention groups
1
Description
ginger capsule (zintoma, goldaru), three times a day, for two weeks
Category
Treatment - Drugs
2
Description
starch capsules as placebo, three times a day, for two weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Cancer Institute
Full name of responsible person
Dr. Bita Kalagchi
Street address
Imam Khomeini Cancer Institute.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman Neuroscience Research Center, Kerman University of Medical Sciences,
Full name of responsible person
Dr. Nozar Nakhai
Street address
Tahmasb abad cross
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman Neuroscience Research Center, Kerman 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
Kerman School of Dentistry
Full name of responsible person
Dr. Arezoo Alaie
Position
Resident of oral medicine
Other areas of specialty/work
Street address
Kerman School of Dentistry, Shafa street
City
Kerman
Postal code
7618759689
Phone
+98 34 1211 9021
Fax
+98 34 1211 8073
Email
g_chamani@kmu.ac.irngln2006@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman School of Dentistry
Full name of responsible person
Dr. Goli Chamani
Position
Associate Professor
Other areas of specialty/work
Street address
Shafa street,Kerman School of Dentistry
City
Kerman
Postal code
7618759689
Phone
+98 34 1211 9021
Fax
+98 34 1211 8073
Email
g_chamani@kmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman School of Dentistry
Full name of responsible person
Dr. Arezoo Alaie
Position
Resident
Other areas of specialty/work
Street address
Kerman School of Dentistry, Jomhori blv, Shafa street,
City
Kerman
Postal code
7618759689
Phone
+98 34 1226 3815
Fax
+98 34 1211 8073
Email
g_chamani@kmu.ac.ir
Web page address
www.kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)