Objective: comparison of the effect of the treatment protocol based on traditional medicine on chronic anal fissure with classic treatment.The study is a double blind clinical trial in females between 20 and 60 years old with chronic anal fissure diagnosed by a gastroenterologist as a chronic fissure without any underlying diseases (IBD, canser, abscess and fistula) who passed the eligible criteria are randomly divide into 2 groups. sample size :60
for the first group Diltigel and high fiber diet and for second group herbal gel and avoid from harmful foods for fissure are administer. Intervention time: at least 4 weeks. Primary outcome : a reduction or improvement in the symptoms of patients on the standard scale evaluation (VAS and SF-36) in the start of intervention, 1, 2, 4 weeks after intervention and 4 weeks after the end of intervention .after the relief of symptoms for definitive diagnosis colonoscopy will be done.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017010731808N1
Registration date:2017-03-05, 1395/12/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-05, 1395/12/15
Registrant information
Name
Sedigheh Tavakoli Dastjerdi
Name of organization / entity
Medical university of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 3855 2188
Email address
tavakkolis901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2017-03-05, 1395/12/15
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the TPM therapeutic protocol efficacy in chronic anal fissure with classic treatment
Public title
The efficacy of herbal ointment in treatment of Anal fissure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: female with chronic anal fissure between 20 and 60 years old with pain and irritation; no fistula or abscess in the anal area; no history of anal cancer.
Exclusion criterion: patients with underlying diseases (crohn disease, ulcerative colitis ); sensitivity to drug ingredients; pregnancy or lactation.
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research, Mashad University of Medical Sciences
Street address
Mashad University of Medical Sciences, Ghoreishi Biulding
City
Mashhad
Postal code
13944-91388
Approval date
2017-01-07, 1395/10/18
Ethics committee reference number
IR.MUMS.REC.1395.483
Health conditions studied
1
Description of health condition studied
Anal fissure
ICD-10 code
K60.1
ICD-10 code description
Chronic anal fissure
Primary outcomes
1
Description
Pain
Timepoint
Before the start of intervention, 1, 2, 4 weeks after intervention and 4 weeks after the end of intervention
Method of measurement
VAS
Secondary outcomes
1
Description
Irritation
Timepoint
Before the start of intervention, 1, 2, 4 weeks after intervention and 4 weeks after the end of intervention
Method of measurement
VAS
2
Description
Bleeding
Timepoint
Before the start of intervention, 1, 2, 4 weeks after intervention and 4 weeks after the end of intervention
Method of measurement
VAS
Intervention groups
1
Description
Intervention group: ITM based protocol local herbal gel from extract of Astragalus fasciculifolius, Comiphora mukul, Syzygium aromaticum:clove, Aloe vera and Allium ampeloprasum, 1 gram BID, and diet based on ITM contains avoid of spicy foods is recommended for 4 weeks
Category
Treatment - Drugs
2
Description
Control group: diltigel, 1 gram BID and high fiber diet is recommended for 4 weeks .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics affliated to Isfahan University of Medical Sciences
Full name of responsible person
Dr. Azam Teymuri
Street address
Isfahan University of Medical Sciences
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi 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
Vice Chancellor for Research, 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
Sedigheh Taavakoli Dastjerdi
Position
PhD Student of Traditional Medicine
Other areas of specialty/work
Street address
Faculty of Iranian Traditional Medicine and Complementary, Opposite the Mehran Sports Hall, East Razi Ave
City
Mashhad
Postal code
Phone
Fax
+98 51 3841 1538
Email
tavakkolis901@mums.c.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Malihe Motavasselian
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Iranian Traditional Medicine and Complementary, Opposite the Mehran Sports Hall, East Razi Ave
City
Mshhad
Postal code
Phone
+98 51 3855 2188
Fax
Email
motavasselianm@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sedigheh Tavkoli Dastjerdi
Position
phD student of Iranian Traditional Medicine
Other areas of specialty/work
Street address
Faculty of Iranian Traditional Medicine and Complementary, Opposite the Mehran Sports Hall, East Razi Ave
City
Mashhad
Postal code
Phone
+98 51 3855 2188
Fax
+98 51 3853 5980
Email
tavakkolis901@mums.ac.ir
Web page address
tavakkolis901@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)