Protocol summary
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Study aim
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The goal of this randomized double blind placebo controlled clinical trial is to prescribe a Hemoheal cream for patients with Hemorrhoid and evaluation of the efficacy of this natural remedy. Compounds of Hemoheal cream are a rectal preparation for hemorrhoid which includes aqueous extract of Allium schoenoprasum L, Commiphora Mukul and Sesamum Indicum L, are being prepared by a traditional pharmacy of the Traditional Medicine Clinic of the Faculty of Traditional Medicine of Tehran University of Medical Sciences.
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Design
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40 patients will be treated randomly with either Hemoheal cream (intervention) or placebo (control) twice a day for 30 days. Each time, 1 thin layer of cream is put on the stance.
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Settings and conduct
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This study is done in Imam Reza hospital of Kermanshah University of Medical Sciences. Blinding is done for patients and physician who measure the outcome of the study. Randomization is performed using blocking method.
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Participants/Inclusion and exclusion criteria
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Major inclusion criteria include: age>18; patients who sign the testimonials and cooperate during the study and patients who were not cured with Hemoheal cream during the last month, and main exclusion criteria include: 4th-degree hemorrhoids; Pregnant patients and nursing mothers; Patients who have to use other drugs that interfere with this medication.
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Intervention groups
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Intervention: Topical use of thin-layer Hemoheal cream twice a day for a month
Control: Topical use of thin-layer eucerin base cream twice a day for a month
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Main outcome variables
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the number of excretion daily and rate of rectal bleeding are primary outcome measures, and gastrointestinal disorders are secondary outcome measure
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017091335460N1
Registration date:
2017-09-13, 1396/06/22
Registration timing:
prospective
Last update:
2017-12-20, 1396/09/29
Update count:
1
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Registration date
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2017-09-13, 1396/06/22
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Kermanshah University of Medical Sciences
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Expected recruitment start date
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2017-10-12, 1396/07/20
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Expected recruitment end date
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2018-01-10, 1396/10/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of the efficacy of rectal preparation from Hemoheal® Cream on number of excretion daily and rate of rectal bleeding in patients with Hemorrhoid
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Public title
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Evaluation of the efficacy of rectal preparation from Hemoheal® Cream in patients with Hemorrhoid
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age>18
Patients who sign the testimonials and cooperate during the study
Patients who their diseases are confirmed by complete medical evaluation including colonoscopy, pathology and laboratory data
Only patients with mild to moderate hemorrhoids can be included in this study
Patients who were not cured with Hemoheal cream during the last month
Exclusion criteria:
4th-degree hemorrhoids
Pregnant patients and nursing mothers
Patients who have to use other drugs that interference with this medication
Previous history of anorectal surgery
Patients who are suffering from other diseases in addition to hemorrhoids, such as apparent coagulation abnormalities or kidney impairment accompanied with colorectal diseases such as cancer, Crohn's disease, ulcerative colitis, anal fistula, anal fissure, proctitis or perineal skin inflammation
Patients who are disposed to a serious health danger, such as severe cardiac, liver or renal diseases
If significant side effects occur, the patient will be excluded from the study and followed to end of the study
Patients with severe allergy to this plant (dermatitis contact)
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization is performed using blocking method.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Blinding is done for patients and physician who measure the outcome of the study.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-10-25, 1396/08/03
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Ethics committee reference number
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IR.KUMS.REC.1396.391
Health conditions studied
1
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Description of health condition studied
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Hemorrohiod
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ICD-10 code
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I84.8
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ICD-10 code description
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Unspecified haemorrhoids with other complications
Primary outcomes
1
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Description
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Number of excretion daily
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Timepoint
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Before using the drug; 2 weeks after using the drug-30 days after using the drugs
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Method of measurement
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Based on Hemorrohiod clinic questionary
2
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Description
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Rate of rectal bleeding
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Timepoint
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before using the drug; 2 weeks after using the drug-30 days after using the drugs
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Method of measurement
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based on Hemorrohiod clinic score
Secondary outcomes
1
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Description
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Gastrointestinal disorders
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Timepoint
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Two weeks after using the drug; 30 days after using the drug
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Method of measurement
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Based on side effect questionary
Intervention groups
1
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Description
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Intervention: Topical use of thin-layer Hemoheal cream twice a day for a month
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Category
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Treatment - Drugs
2
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Description
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Control: Topical use of thin-layer eucerin base cream twice a day for a month
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice Chancellor for Research, Kermanshah University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available