Protocol summary

Summary
The aim of this randomized, double blind study is to evaluate and compare the therapeutic effects of topical steroid with honey plus coffee in the treatment of patients with Oral Mucositis after chemotherapy and/or radiotherapy. A total of about 75 adult participants who are experiencing Oral Mucositis after chemotherapy and/or radiotherapy, are assigned into the following three groups. For all the participants a syrup-like solution is prepared. Each 500 cc of the product consisted of "20 ampoules that each one contained 8 mg Betamethasone" in the first group, "300 grams of honey plus 20 grams of instant coffee" in the second group, and placebo for the third group. These participants are told to sip 10 cc of the prescribed product, and then swallow it every 3 hours for one week. Severity of lesions is evaluated before and after the treatment and also one week after the intervention and is compared between three groups. This study is in the 3rd phase now.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201104074737N3
Registration date: 2011-05-09, 1390/02/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-05-09, 1390/02/19
Registrant information
Name
Mohammad Ali Raeessi
Name of organization / entity
Baqiyatallah University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 8803 0514
Email address
raeessi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Dr. Mohammad Ali Raeessi + Baqiyatallah University of Medical Sciences
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2011-09-21, 1390/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison study of the therapeutic effect of " topical steroid" and "honey plus coffee" on Oral Mucositis after chemotherapy and/or radiotherapy.
Public title
A comparison study of the therapeutic effect of " topical steroid" and "honey plus coffee" on Oral Mucositis after chemotherapy and/or radiotherapy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Oral Mucositis after chemotherapy and/or radiotherapy /age between 15 and 80 years. Exclusion criteria: Out of this age range - presence of other systemic disease and gastrointestinal disorders.
Age
From 15 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
None
Sample size
Target sample size: 75
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
Ethic Committee in Medical Sciences Research, Deputy of Research and Technology, Baqiyatallah Univer
Street address
Sheikhbahaee St., Mollasadra Ave
City
Tehran
Postal code
Postcode: 14359 - P.
Approval date
2009-03-16, 1387/12/26
Ethics committee reference number
C/340/10/15/100

Health conditions studied

1

Description of health condition studied
K13.7 Other and unspecified lesions of oral mucosa
ICD-10 code
K13.7
ICD-10 code description
K13.7

Primary outcomes

1

Description
Oral Mucositis after chemotherapy and/or radiotherapy.
Timepoint
Before and after the treatment and also one week after the treatment
Method of measurement
Oral lesions: normal (0), low (+), moderate (++), and severe (+++)

Secondary outcomes

1

Description
Pain
Timepoint
Before and after the treatment and also one week after the treatment
Method of measurement
Normal (0), low (+), moderate (++), and severe (+++)

Intervention groups

1

Description
Intervention1 : 500 ml solution containing 20 ampoules that each one contained 8 mg betamethasone" The participants are told to sip 10 cc of the prescribed product, and then swallow it every 3 hours for one week
Category
Treatment - Other

2

Description
Intervention2 : 500 ml solution containing 300gram honey and 20 gram coffee; The participants are told to sip 10 cc of the prescribed product, and then swallow it every 3 hours for one week
Category
Treatment - Drugs

3

Description
Intervention3: 500 ml solution containing placebo" The participants are told to sip 10 cc of the prescribed product, and then swallow it every 3 hours for one week
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah UniversityHospital of Medical Sciences ( and the Hospital)
Full name of responsible person
Dr. Mohammad Ali Raeessi
Street address
Sheikhbahaee St., Mollasadra Ave
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Dr. Mohammad Ali Raeessi + Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Raeessi
Street address
No117, Molasadra residental complex, Kharazmi st., Mollasadra Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dr. Mohammad Ali Raeessi + Baqiyatallah 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
Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Raeessi
Position
Assistant professor
Other areas of specialty/work
Street address
No: 117, Mollasadra residental complex, Kharazmi St, Mollasadra Ave.
City
Tehran
Postal code
1435913118
Phone
+98 21 8803 0514
Fax
Email
raeessi_ma@yahoo.com; raeessi@bmsu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Raeessi
Position
Assistant professor
Other areas of specialty/work
Street address
No 117, Molasadra residental complex, Kharazmi st., Mollasadra Ave.
City
Tehran
Postal code
1435913118
Phone
+98 21 8803 0514
Fax
Email
raeessi_ma@yahoo.com; raeessi@bmsu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Baqiyatallah Universityof Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Raeessi
Position
Assistant Prof.
Other areas of specialty/work
Street address
No: 117, Molasadra residental complex, Kharazmi St., Mollasadra Ave.
City
Tehran
Postal code
1435913118
Phone
+98 21 8803 0514
Fax
Email
raeessi_ma@yahoo.com; raeessi@bmsu.ac.ir
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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