Protocol summary
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Study aim
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This study aims to investigate the efficacy and safety of a rectal product containing Myrtle's and Chamomile in hemorrhoids compared to anti-hemorrhoid ointment
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Design
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Clinical trial with a parallel control group, with a sample size of 90 patients, single blind, randomized by block randomization method
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Settings and conduct
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Patients referring to the outpatient clinic of gastroenterology and general surgery and colonoscopy department of the Imam Khomeini Hospital Complex, who are diagnosed with hemorrhoids, will be evaluated. An announcement poster about the study will be provided in pharmacies of the faculty of pharmacy and social media to accelerate recruitment.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Age 20 to 65 years; Hemorrhoid grade 1-2 based on the BPRST definition (bleeding, prolapse, reduction, skin tags, thrombosis)
Non-inclusion criteria: several underlying diseases, using the research medication or medications with the same active ingredient
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Intervention groups
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In the intervention group, Rectus® ointment (Iran Darouk) is used rectally, one applicator (1gram) twice a day for two weeks. Patients in control group receive anti-hemorrhoid ointment (Aburihan) rectally similarly. Both groups receive proper laxative and recommendations on lifestyle modification orally and written.
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Main outcome variables
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Severity of hemorrhoid symptoms before and two weeks after the start of the intervention
General information
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Reason for update
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Due to the completion of the study, the dates of enrollment is determined and updated in the text.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120125008819N3
Registration date:
2022-12-12, 1401/09/21
Registration timing:
prospective
Last update:
2025-02-05, 1403/11/17
Update count:
1
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Registration date
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2022-12-12, 1401/09/21
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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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Expected recruitment start date
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2022-12-22, 1401/10/01
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Expected recruitment end date
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2023-08-23, 1402/06/01
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Actual recruitment start date
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2022-12-22, 1401/10/01
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Actual recruitment end date
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2023-10-03, 1402/07/11
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Trial completion date
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2023-10-17, 1402/07/25
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Scientific title
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Investigating the efficacy of herbal ointment (Chamomile and Myrtus) compared to anti-hemorrhoid ointment in the treatment of patients with hemorrhoids in a randomized clinical trial
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Public title
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Comparison of the efficacy of Chamomile and Myrtus ointment in comparison with anti-hemorrhoid ointment
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age between 20 to 65 years
Hemorrhoid grade 1-2 based on the BPRST definition
Exclusion criteria:
Hemorrhoid requiring surgery
External thrombosed and strangulated hemorrhoid
Anal fistula
Anal fisher
Anal abscess
Portal hypertension
Pregnancy
Breastfeeding
History of inflammatory bowel diseases
History of gastrointestinal malignancy
Severe and acute cardiovascular disease
Severe and acute liver disease
Renal failure
Asthma
Using oral corticosteroids
Food or inhalation allergy needs medication therapy
Use of the current research medications
Rectal use of medications with the same active ingredient as the research medications
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Age
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From 20 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
100
Actual sample size reached:
84
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will be allocated to the intervention and control groups using the block randomization method (block of 4). Randomization will be done centrally and before the initiation of the study by someone who is not directly involved in the recruitment of participants. Those who enroll patients in the study will not know the order of allocations. A senior researcher and clinical trial supervisor prepare a patient allocation plan based on the randomization list. Group codes of new patients will be handed over in separate sealed envelopes to the senior field researcher. So, the allocation of new patients to the groups will be hidden and will not be predictable
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Due to the products' characteristics, it is impossible to blind the patient in this study, and the study is conducted as a single-blind study. The researcher who evaluate the outcomes will not be aware of the medication received by the patients. In other words, the assignment of patients to groups and handing the drugs to patients will be done by another researcher.
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Placebo
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Not 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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2022-10-18, 1401/07/26
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Ethics committee reference number
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IR.TUMS.IKHC.REC.1401.210
Health conditions studied
1
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Description of health condition studied
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Hemorrhoids
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ICD-10 code
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K64
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ICD-10 code description
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Hemorrhoids and perianal venous thrombosis
Primary outcomes
1
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Description
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Severity of hemorrhoid signs/symptoms including bleeding, persistent pain, pain during defecation, anal itching, and tenesmus
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Timepoint
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Before, one week, andtwo weeks after the initiation of the study
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Method of measurement
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The presence and severity of each of the signs/symptoms (from 1 to 10) based on taking a history
2
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Description
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Severity of hemorrhoid symptoms considering their interferences with daily activity (Scores 0-3)
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Timepoint
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Before and two weeks after the initiation of the study
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Method of measurement
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History taking ( 0=no symptoms, 1=symptoms without any effects on daily activity, 2= symptoms that affects daily activity, 3= Severe interference with daily activity)
Intervention groups
1
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Description
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Intervention group: Rectal ointment containing Myrtle and Chamomile: In the intervention group, Rectus® ointment (produced by Iran Darouk Company) is used rectally, one applicator (containing one gram of the ointment) twice a day for two weeks. Every 30 grams (one tube) of Rectus® Ointment contains 8.1 grams of standardized essential oil of Myrtus communis and 0.3 grams of dried Matricaria chamomilla extract.
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Category
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Treatment - Drugs
2
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Description
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Control group: Rectal ointment of anti-hemorrhoids: Patients assigned to the control group receive anti-hemorrhoid ointment (produced by Aburihan company) rectally, one applicator (containing one gram of the ointment) twice a day for two weeks. Anti-hemorrhoid ointment contains hydrocortisone acetate (2.75 mg/g), lidocaine (50 mg/g), aluminum subacetate (35 mg/g) and zinc oxide (180 mg/g).
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Category
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Treatment - Drugs
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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No
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Title of funding source
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Iran Darouk Pharmaceutical-Cosmetic Company
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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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Private
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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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Industry
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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Undecided - It is not yet known if there will be 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