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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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History
# Registration date Revision Id
2 2025-01-21, 1403/11/02 329607
1 2022-12-12, 1401/09/21 248784
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  • Protocol summary

    مراجعه کنندگان به درمانگاه گوارش وجراحی عمومی و بخش کولونوسکوپی مجتمع بیمارستانی امام خمینی پس از بررسی بالینی کامل و تشخیص هموروئید، از لحاظ معیارهای مطالعه بررسی می شوند. جهت افزایش سرعت بیماریابی، اطلاع رسانی در داروخانه هاي دانشکده داروسازی دانشگاه و شبکه های اجتماعی نیز انجام مي گيرد.
    مراجعه کنندگان به درمانگاه گوارش و جراحی عمومی و بخش کولونوسکوپی مجتمع بیمارستانی امام خمینی پس از بررسی بالینی کامل و تشخیص هموروئید، از لحاظ معیارهای مطالعه بررسی می شوند. جهت افزایش سرعت بیماریابی، اطلاع رسانی در داروخانه های دانشکده داروسازی دانشگاه و شبکه های اجتماعی نیز انجام مي گيرد.

  • General information

    90
    100
    No
    No
    empty
    84
    2022-11-30, 1401/09/09
    2022-12-22, 1401/10/01
    2023-03-21, 1402/01/01
    2023-08-23, 1402/06/01
    empty
    2022-12-22, 1401/10/01
    empty
    2023-10-03, 1402/07/11
    empty
    2023-10-17, 1402/07/25
    empty
    Due to the completion of the study, the dates of enrollment is determined and updated in the text.
    empty
    با توجه به اتمام مطالعه، تاریخ های بیمارگیری مشخص شده است که در متن به روز رسانی می شود.
    Comparison of the efficacy of Chamomile and Myrtus ointment in comparison with anti-hemorrhoid ointment for the treatment of hemorrhoids
    Comparison of the efficacy of Chamomile and Myrtus ointment in comparison with anti-hemorrhoid ointment
    مقايسه اثربخشي پماد بابونه و مورد در مقایسه با پماد آنتی هموروئید براي درمان هموروئید
    مقايسه اثربخشی پماد بابونه و مورد در مقایسه با پماد آنتی هموروئید
    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
    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

  • Intervention groups

    #1
    گروه مداخله: پماد حاوي مورد و بابونه به صورت رکتال: در گروه مداخله ، پماد رکتوس® (تولید شرکت ایران داروک) به صورت رکتال روزی دو بار، هر بار یک اپلیکاتور (حاوی یک گرم از پماد) به مدت 2 هفته مصرف می شود. هر 30 گرم (یک تیوب) از پماد رکتوس® حاوی 8.1 گرم اسانس استاندارد شده گیاه Myrtus communis و 0.3 گرم عصاره خشک Matricaria chamomilla است.
    گروه مداخله: پماد حاوی مورد و بابونه به صورت رکتال: در گروه مداخله ، پماد رکتوس® (تولید شرکت ایران داروک) به صورت رکتال روزی دو بار، هر بار یک اپلیکاتور (حاوی یک گرم از پماد) به مدت 2 هفته مصرف می شود. هر 30 گرم (یک تیوب) از پماد رکتوس® حاوی 8.1 گرم اسانس استاندارد شده گیاه Myrtus communis و 0.3 گرم عصاره خشک Matricaria chamomilla است.
    #2
    گروه کنترل: پماد آنتي هموروئيد به صورت رکتال: بیماران تخصیص یافته به گروه کنترل، پماد آنتی هموروئید (تولید شرکت ابوریحان ) را به صورت رکتال دو بار در روز به مدت 2 هفته دریافت می کنند. پماد آنتی هموروئید حاوی هیدروکورتیزون استات( mg/g 2.75) لیدوکائین( mg/g 50) ، آلومینیوم ساب استات ( mg/g 35) و زینک اکساید ( mg/g180) می باشد. در هر نوبت یک اپلیکاتور (حاوی 1 گرم) از این پماد استعمال می شود.
    گروه کنترل: پماد آنتی هموروئيد به صورت رکتال: بیماران تخصیص یافته به گروه کنترل، پماد آنتی هموروئید (تولید شرکت ابوریحان ) را به صورت رکتال دو بار در روز به مدت 2 هفته دریافت می کنند. پماد آنتی هموروئید حاوی هیدروکورتیزون استات( 2.75 میلی گرم در هر گرم پماد) لیدوکائین (50 میلی گرم در هر گرم پماد) ، آلومینیوم ساب استات (35 میلی گرم در هر گرم پماد) و زینک اکساید (180 میلی گرم در هر گرم پماد) می باشد. در هر نوبت یک اپلیکاتور (حاوی 1 گرم) از این پماد استعمال می شود.

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Foroogh Alborzi Avanaki
    Full name of responsible person - Persian: فروغ البرزی اوانکی
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: sub_specialist
    Area of specialty/work: 40
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Chamran highway, Bagherkhan St. ,Imam Khomeini Hospital Complex
    Street address - Persian: بزرگراه چمران، خيابان باقرخان، مجتمع بيمارستاني امام خميني
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۱۴۱۹۷۳۳۱۴۱
    Phone: +98 21 6119 0000
    Mobile: +98 912 561 7101
    Fax:
    Email: foroogh1983@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Foroogh Alborzi Avanaki
    Full name of responsible person - Persian: فروغ البرزی اوانکی
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: sub_specialist
    Area of specialty/work: 40
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Chamran highway, Bagherkhan St. ,Imam Khomeini Hospital Complex
    Street address - Persian: بزرگراه چمران، خيابان باقرخان، مجتمع بيمارستانی امام خمينی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۱۴۱۹۷۳۳۱۴۱
    Phone: +98 21 6119 0000
    Mobile: +98 912 561 7101
    Fax:
    Email: foroogh1983@yahoo.com
    Web page address:

Protocol summary

Study aim
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
Design
Clinical trial with a parallel control group, with a sample size of 90 patients, single blind, randomized by block randomization method
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
Severity of hemorrhoid symptoms before and two weeks after the start of the intervention

General information

Reason for update
Due to the completion of the study, the dates of enrollment is determined and updated in the text.
Acronym
IRCT registration information
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
Registration date
2022-12-12, 1401/09/21
Registrant information
Name
Mona Kargar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8881 4157
Email address
mkargar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
2022-12-22, 1401/10/01
Actual recruitment end date
2023-10-03, 1402/07/11
Trial completion date
2023-10-17, 1402/07/25
Scientific title
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
Public title
Comparison of the efficacy of Chamomile and Myrtus ointment in comparison with anti-hemorrhoid ointment
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 100
Actual sample size reached: 84
Randomization (investigator's opinion)
Randomized
Randomization description
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
Blinding (investigator's opinion)
Single blinded
Blinding description
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Imam Khomeini Hospital Complex, Tehran University of Medical Sciences
Street address
Chamran highway, Bagherkhan St., Imam Khomeini Hospital Complex
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2022-10-18, 1401/07/26
Ethics committee reference number
IR.TUMS.IKHC.REC.1401.210

Health conditions studied

1

Description of health condition studied
Hemorrhoids
ICD-10 code
K64
ICD-10 code description
Hemorrhoids and perianal venous thrombosis

Primary outcomes

1

Description
Severity of hemorrhoid signs/symptoms including bleeding, persistent pain, pain during defecation, anal itching, and tenesmus
Timepoint
Before, one week, andtwo weeks after the initiation of the study
Method of measurement
The presence and severity of each of the signs/symptoms (from 1 to 10) based on taking a history

2

Description
Severity of hemorrhoid symptoms considering their interferences with daily activity (Scores 0-3)
Timepoint
Before and two weeks after the initiation of the study
Method of measurement
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)

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
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).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Foroogh Alborzi Avanaki
Street address
بزرگراه چمران، خيابان باقرخان، مجتمع بيمارستاني امام خميني
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
foroogh1983@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotouhi
Street address
Tehran University of medical Sciences, Ghods St junction with Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran Darouk Pharmaceutical-Cosmetic Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mona Kargar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
4th floor, No: 92, South Kheradmand Junction, Karimkhan-e-zand Ave
City
Tehran
Province
Tehran
Postal code
1584775315
Phone
+98 21 8881 4157
Email
mkargar@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Foroogh Alborzi Avanaki
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Chamran highway, Bagherkhan St. ,Imam Khomeini Hospital Complex
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 0000
Email
foroogh1983@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mona Kargar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
4th floor, No: 92, South Kheradmand Junction, Karimkhan-e-zand Ave
City
Tehran
Province
Tehran
Postal code
1584775315
Phone
+98 21 8881 4157
Email
mkargar@razi.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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