Formulation, physicochemical evaluation and comparison of the effect of ointment prepared from Myrtus communis L. and Colchicum automnale L. with anti-hemorrhoid ointment on the symptoms of grade I and II internal hemorrhoids: a three-blind controlled clinical trial
Comparison of the effect of ointment prepared from Myrtle and wild-saffron medicinal plants with anti-hemorrhoid ointment on the symptoms of grade I and II internal hemorrhoids.
Design
This three-blind randomized clinical trial will be conducted on 60 men and women with grade I and II hemorrhoids.
Settings and conduct
Patients referred to Tabriz medical centers will be assigned to two intervention and control groups using random block design. The intervention group will receive herbal ointment and the control will receive anti-hemorrhoid ointment twice a day for 4 week. With the colorectal clinical evaluation questionnaire, the amount of pain, itching, swelling, bleeding, anal discomfort and the negative effect of hemorrhoids on people's sense of health and well-being will be investigated.
Participants/Inclusion and exclusion criteria
Entry requirements;
Patients in the age group of 17 to 70, literate and suffering from 1 and 2 degree hemorrhoids
Non-entry condition;
Use of systemic steroidal and non-steroidal anti-inflammatory drugs and analgesic treatments; and anti hemorrhoid (for one month before the study) and the use of anticoagulant drugs; The need for surgery to treat hemorrhoids
Suffering from inflammatory infectious diseases of the digestive tract or colorectal cancer; Previous use of laser or use of phlebutonic drug to treat hemorrhoids one week before from entering the study or participating in another interventional study
Intervention groups
The people of the intervention group, including 60 men and women with first and second degree hemorrhoids, will receive herbal ointment. Also, the control group will include 60 men and women with first and second grade hemorrhoids, who will receive anti-hemorrhoid ointment.
Main outcome variables
formulation of anti-hemorrhoid ointment
Determining the effect of this ointment on the symptoms of grade I and II internal hemorrhoids
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221013056160N1
Registration date:2022-12-18, 1401/09/27
Registration timing:prospective
Last update:2022-12-18, 1401/09/27
Update count:0
Registration date
2022-12-18, 1401/09/27
Registrant information
Name
Negar Valizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3330 7795
Email address
n.valizadeh@rifr-ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-11, 1401/10/21
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Formulation, physicochemical evaluation and comparison of the effect of ointment prepared from Myrtus communis L. and Colchicum automnale L. with anti-hemorrhoid ointment on the symptoms of grade I and II internal hemorrhoids: a three-blind controlled clinical trial
Public title
Investigating the effect of ointment prepared from Myrtus communis L. and Colchicum automnale L. for the treatment of grade I and II internal hemorrhoids
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clients with first and second grade hemorrhoids who have been diagnosed with clinical symptoms and confirmation from a general surgeon.
Patients should be in the age group of 17 to 70 years.
Hemorrhoids of the clients are not caused by systemic diseases such as hypertension.
Presence of hemorrhoid symptoms for at least more than 6 days
Ability to read and write
Exclusion criteria:
Use of systemic steroidal and non-steroidal anti-inflammatory drugs and analgesic treatments
The use of systemic steroidal and non-steroidal anti-inflammatory drugs and analgesic and anti-hemorrhoid treatments (for one month before the study) and the use of anticoagulant drugs.
The need for a surgical method to treat hemorrhoids (with the approval of a gastroenterologist and using clinical and colonoscopy tests)
Patients with problems such as anorectal abscess, fistula, tuberculosis, herpes, varicella (confirmed by clinical tests or colonoscopy)
Infectious inflammatory diseases of the digestive tract or colorectal cancer (according to the patient's statement)
Previous use of laser or use of phlebotonic medicine to treat hemorrhoids one week before entering the study (according to the patient's statement)
Participation in another interventional study
Age
From 17 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation rule
This method represents a large block for the entire sample volume, which means that the balance in the number of people
It will be allocated to each of the groups at the end of the study.
For this purpose, he first determined a total sample size, then randomly assigned a group of them to group A and the rest to group B.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This three-blind randomized clinical trial will be conducted on 60 men and women with grade I and II hemorrhoids referring to health and treatment centers in Tabriz city. Eligible people will be assigned to two intervention and control groups using random block. In this study, the researcher, participant and clinical caregiver will not know the type of intervention received by the participants.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of TAbriz University of Medical Sciences
Street address
Tabriz University, Building No. 2 of Medical Sciences, Research and Technology Vice-Chancellor, 3rd floor
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۶۶۶۱۶۴۷۱
Approval date
2022-09-12, 1401/06/21
Ethics committee reference number
IR.TBZMED.REC.1401.516
Health conditions studied
1
Description of health condition studied
grade I and II internal hemorrhoids
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Investigating the amount of pain with the colo-rectal clinical treatment evaluation questionnaire
Timepoint
This questionnaire will be completed once before the start of the study and then in the first, second and fourth weeks, and once after the end of the intervention, in the eighth week after the start of the treatment.
Method of measurement
(CORECTS= Colo-Rectal Evaluation of Clinical Therapeutics Scale)
2
Description
Investigating the amount of itching around the anus with the colorectal clinical treatment evaluation questionnaire
Timepoint
This questionnaire will be completed once before the start of the study and then in the first, second and fourth weeks, and once after the end of the intervention, in the eighth week after the start of the treatment.
Method of measurement
(CORECTS= Colo-Rectal Evaluation of Clinical Therapeutics Scale)
3
Description
Investigating the amount of bleeding with the colo-rectal clinical treatment evaluation questionnaire
Timepoint
This questionnaire will be completed once before the start of the study and then in the first, second and fourth weeks, and once after the end of the intervention, in the eighth week after the start of the treatment.
Method of measurement
(CORECTS= Colo-Rectal Evaluation of Clinical Therapeutics Scale)
Secondary outcomes
1
Description
The questionnaire (WHOQOL-BREF) will be used to measure the quality of life
Timepoint
This questionnaire will be completed before the start of the study, in the fourth week after the intervention and in the eighth week after the start of the treatment.
Method of measurement
Questionnaire (WHOQOL-BREF)
Intervention groups
1
Description
Intervention group: Intervention group: The intervention group includes 60 men and women with first and second degree hemorrhoids, referring to medical centers in Tabriz city, who will receive the herbal ointment.
Category
Treatment - Drugs
2
Description
Control group: The control group will include 60 men and women with first and second grade hemorrhoids in the same centers that will receive anti-hemorrhoid ointment or suppositories.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Sajjad Hospital
Full name of responsible person
Babak Abri Aghdam
Street address
East side of Pasdaran highway,Educational complex of Islamic Azad University of Tabriz, Imam Sajjad Hospital, Tabriz, Iran