Protocol summary

Summary
The aim of this study was to investigate the effects of jaft of quercus compared to anti-hemorrhoid ointmenton hemorrhoid, For this purpose, the effect of jaft of quercuson hemorrhoid was investigated in terms of age, gender, type of hemorrhoid, and level of satisfaction, and the effect of anti-hemorrhoid ointment on hemorrhoid in terms of age, gender, and type of hemorrhoid. The study included the patients with grade I and II hemorrhoids who were candidates for surgery, and no specific exclusion criteria were considered for this study. The intervention included the use of jaft of quercus in one group and anti-hemorrhoid ointment in another group of patients with hemorrhoid admitted to Shohada Ashayer hospital of Khorramabad. Sampling was conducted through the non-probable, double blinded sampling method.Acorns, scientific known as quercus, were collected from Doroud and Khorramabad and sent to the laboratory. The acorns were dried at appropriate temperature and their woody skins were removed.The patients consumed thesoft skin, which is called jaft and hascontractile properties, for 4-6 weeks.Then the patients were evaluated after this period in terms of improvement and complications. The sample size in each group included 30 patients. Contraction of hemorrhoid, shrinkage of the size, and reduction of the pain were the primary outcomes, and rapid recovery without side effects and irreversibility of hemorrhoid were the main outcomes of the consumption of jaft

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014061217123N2
Registration date: 2014-09-26, 1393/07/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-09-26, 1393/07/04
Registrant information
Name
Mojtaba Ahmadinejad
Name of organization / entity
Lorestan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 1322 3004
Email address
dr.ahmadinejad@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Lorestan University of Medical Sciences and Health Services
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of jaft of quercus compared to anti-hemorrhoid ointment on hemorrhoid treatment in patients with hemorrhoid
Public title
Effect of jaft of quercus compared to anti-hemorrhoid ointment on hemorrhoid treatment
Purpose
Treatment
Inclusion/Exclusion criteria
The study included the patients with grade I and II hemorrhoids who were candidates for surgery, and no specific exclusion criteria were considered for this study
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not 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
Lorestan University of Medical Sciences
Street address
Lorestan University of Medical Sciences,Street Teacher, Khorramabad
City
Khorramabad
Postal code
6816991
Approval date
2014-04-19, 1393/01/30
Ethics committee reference number
975/93/200

Health conditions studied

1

Description of health condition studied
Hemorrhoids
ICD-10 code
I84
ICD-10 code description
Haemorrhoids

Primary outcomes

1

Description
Decrease Pain
Timepoint
4-6 week
Method of measurement
Patient statements

2

Description
Reduce bleeding and itching
Timepoint
4-6 week
Method of measurement
Statements made by the patient and examined by a doctor

3

Description
Decrease inflammation and protrusions
Timepoint
4-6 week
Method of measurement
examined by a doctor

Secondary outcomes

1

Description
Defecation without pain and bleeding.
Timepoint
6 week
Method of measurement
The physical examination and observation

Intervention groups

1

Description
The intervention included the consumption of jaft of quercus in the patients with hemorrhoid applied locally on the hemorrhoid sites 3 times daily for 4-6 weeks, and the dose depended on the covering surface.
Category
Treatment - Drugs

2

Description
In the control group, anti-hemorrhoid ointment was used in the patients with hemorrhoid applied locally on the hemorrhoid sites 3 times daily for 4-6 weeks, and the dose depended on the covering surface.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada Ashayer Hospital Clinic
Full name of responsible person
dr.ahmadinejad
Street address
Shohada Ashayer Hospital Clinic Subspecialty
City
khorramabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
dr.Mojtaba Ahmadinejad
Street address
Clinic Subspecialty,Shohada Ashayer Hospital
City
khorramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan 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
Lorestan University Of Medical Sciences
Full name of responsible person
Dr.Mojtaba Ahmadinejad
Position
Specialty Thoracic
Other areas of specialty/work
Street address
Department of Surgery,Shohada Ashater Hospital,Revolution Street
City
khorramabad
Postal code
Phone
+98 66 1322 3004
Fax
Email
dr_ts_ahmadinejad@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr.Mojtaba Ahmadinejad
Position
Specialty Thoracic
Other areas of specialty/work
Street address
Department of Surgery, shohada ashayer Hospital,Revolution Street
City
khorramabad
Postal code
Phone
+98 66 1322 3004
Fax
Email
dr_ts_ahmadinejad@yahoo.com
Web page address

Person responsible for updating data

Contact

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
Loading...