Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000223932
Ethics application status
Approved
Date submitted
15/02/2011
Date registered
1/03/2011
Date last updated
1/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of an oral herbal compound in treatment of acute anal fissure
Scientific title
In patients with acute anal fissure, treatment with oral herbal remedies in comparison to placebo will alleviate signs and symptoms (pain, itching, bleeding) of patients.
Secondary ID [1] 253607 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute anal fissure 261168 0
Condition category
Condition code
Alternative and Complementary Medicine 259322 259322 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral administration of one capsule 40 mg containing herbal compounds (mixture of salep and Ginger) three times a day (before breakfast, lunch and dinner) for 6 days
Intervention code [1] 258031 0
Treatment: Other
Comparator / control treatment
Placebo capsules (made up of starch) with the same dose and route of administration
Control group
Placebo

Outcomes
Primary outcome [1] 262126 0
Alleviation of pain and itching assessing by questionnaires containing questions about presence and severity of signs and symptoms correlated with fissure.
Timepoint [1] 262126 0
3 days after initiation of treatment
Secondary outcome [1] 273207 0
anatomical improvement of anal fissure and recovery of bleeding assessing by questionnaires and physical exam.containing questions about presence and severity of signs and symptoms correlated with fissure.
Timepoint [1] 273207 0
6 days after initiation of treatment

Eligibility
Key inclusion criteria
Patients with proven anal fissure with 4 weeks or lower from initiation of the disease.
Minimum age
0 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnant women
2. Patients with uncontrolled acute or systemic illnesses
3. Inflammatory bowl disease
4. Chronic fissure
5. Use of psychiatric medications due to acute psychiatric illness

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 3197 0
Iran, Islamic Republic Of
State/province [1] 3197 0

Funding & Sponsors
Funding source category [1] 258503 0
University
Name [1] 258503 0
Shiraz University of medical science-
Country [1] 258503 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Shiraz University of medical science, Deputy of research and technology
Address
Shiraz University of medical science-Zand AVe, Fars, IranP.C:71345-1845
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 257639 0
Individual
Name [1] 257639 0
Kamran Bagheri Lankarani
Address [1] 257639 0
Health policy research center,5th floor, Shiraz medical school, Zand Ave, Shiraz, Fars province, Iran.
P.C: 71345-1877
Country [1] 257639 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260479 0
Local ethical committe of Shiraz University of medical sciences
Ethics committee address [1] 260479 0
Ethics committee country [1] 260479 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 260479 0
Approval date [1] 260479 0
Ethics approval number [1] 260479 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32215 0
Address 32215 0
Country 32215 0
Phone 32215 0
Fax 32215 0
Email 32215 0
Contact person for public queries
Name 15462 0
Ahad Eshraghian
Address 15462 0
Internal medicine department, Namazi Hospital, Zand Ave, Shiraz, Fars, Iran
P.C 71345-1744
Country 15462 0
Iran, Islamic Republic Of
Phone 15462 0
00989177311442
Fax 15462 0
Email 15462 0
[email protected]
Contact person for scientific queries
Name 6390 0
Kamran B Lankarani
Address 6390 0
Health policy research center, 5th floor, Shiraz University of medical science, Zand Ave, Shiraz, Fars, Iran.
P.C: 71345-1877
Country 6390 0
Iran, Islamic Republic Of
Phone 6390 0
0098 711 230 9615
Fax 6390 0
Email 6390 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.