Objectives: The aim of this study is investigating the effect of product of Malva Sylvestris on intestinal side effects of radiotherapy (radiation proctitis) Setting and conduct: In clinical trials, patients received pelvic radiation in Shohadaye Tajrish and Imam Khomeini Hospital in the first session of radiotherapy asked about frequency and severity of gastrointestinal symptoms, (with Acute Radiation Morbidity Scoring Criteria and visual analog scale) and then patients in two groups (case and control) receive drug or placebo from first session of radiotherapy until end of that and symptoms are evaluated using same criteria In the third week of treatment, end of treatment and again at the second week after irradiation. Participants including major eligibility criteria: patient should receive pelvic radiation; Age betwen18 to 80 years excluding criteria: other natural therapy during the study; thrombotic diseases;Cardiovascular disease; Diabetes; Hypertension; Severe cognitive impairment; Psychotic disorder intervention:patient received drug and placebo in shape of sachet (12 mg in three doses) Outcome: Then Using statistical tests, the effectiveness of the product, are analyzed including diarrhea, tenesmus, urgency, rectal pain, anal irritation, bleeding and incontinence
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012101011064N1
Registration date:2014-04-19, 1393/01/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-19, 1393/01/30
Registrant information
Name
Reihaneh Moeini
Name of organization / entity
Traditional medicine of Tehran university
Country
Iran (Islamic Republic of)
Phone
+98 21 2252 6705
Email address
r-moeini@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for education, faculty of ،Traditional Medicine, Tehran university of Medical Sciences
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2014-07-01, 1393/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial of malva Sylvestris L. formulation on intestinal side effects of pelvic cancers radiation
Public title
Evaluation of Malva Sylvestris. formulation on Radiation proctitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
patients who are planed pelvic radiotherapy with impression of cancer
Age over 18 years;
Non Inclusion criteria:
Other natural therapy during the study;
Thrombotic diseases;
Known gastrointestinal disease before radiotherapy;
severe Cardiovascular disease;
uncontrolled Diabetes;
severe Hypertension;
Severe cognitive impairment;
Psychotic disorder
Age
From 18 years old to 80 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
none
Secondary trial Id
none
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the School of Traditional Medicine, Tehran University of Medical Sciences
Street address
Research institu of Islamic & Traditional medicin
City
Tehran
Postal code
Approval date
2012-12-09, 1391/09/19
Ethics committee reference number
پ26/م ط/ 933
Health conditions studied
1
Description of health condition studied
Radiation proctitis
ICD-10 code
k62.7
ICD-10 code description
Radiation proctitis
Primary outcomes
1
Description
Anal Burning
Timepoint
Every 3 weeks
Method of measurement
visual analog scale 0-10
2
Description
Diarrhea
Timepoint
every 3 week
Method of measurement
visual analog scale 0-10
3
Description
Fecal incontinence
Timepoint
every 3 weeks
Method of measurement
visual analog scale
4
Description
Fecal urgency
Timepoint
every 3 weeks
Method of measurement
visual analog scale
5
Description
anal bleeding
Timepoint
every 3 weeks
Method of measurement
visual analog scale
6
Description
Excretion of mucous
Timepoint
every 3 weeks
Method of measurement
visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group patient should use sachet of Malva, 12 mg in 3 dosage that should brewed in boiled water, from first day of radiation until end of that.(each pocket is 4 g)
Category
Prevention
2
Description
All patients in control group take powder of placebo which is designed for this study in 4 mg packets in three dosages a day orally with a glass of hot water.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Cancer Center
Full name of responsible person
Reihaneh Moeini
Street address
Imam Khomeini Hospital,End of Keshavarz Blv., Tehran, Iran
City
Tehran
2
Recruitment center
Name of recruitment center
Radiation Center of Shohadae Tajrish Hospital
Full name of responsible person
Reihaneh Moeini
Street address
Ghods Sq., Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for education, faculty of ،Traditional Medicine, Tehran university
Full name of responsible person
Mohammadreza Fartookzadeh
Street address
Office of Vice Chancellor for education, Third floor, Faculty of Traditional Medicine, Behesht St., Vahdat Eslami St. (South Hafiz), Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for education, faculty of ،Traditional Medicine, Tehran university
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
Faculty of Traditional Medicine, Tehran university of medical science
Full name of responsible person
Reihaneh Moeini
Position
PhD Assistant
Other areas of specialty/work
Street address
No 6, yazdan st.,Shahid Araghi St., Khaje abdollah st.,Shariati St., Tehran
City
Tehran
Postal code
Phone
+98 912 606 5380
Fax
Email
rhei_mo@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran university of medical science
Full name of responsible person
Farshid Farhan
Position
Professor of Radiotherapy- Oncology
Other areas of specialty/work
Street address
Rdiation center of Imam Khomeini Hospital, End of Keshavarz Bov.
City
Tehran
Postal code
Phone
+98 912 199 3049
Fax
Email
farhan@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of traditional medicine, Tehran university of medical science
Full name of responsible person
Reihane Moeini
Position
PhD assistant
Other areas of specialty/work
Street address
No 6, Yazdan st.Shahid Araghi st., Khaje abdollah st., Shariati St., Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
rhei_mo@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)