Study of therapeutic effects of ointment containing hydro alcoholic extract of root and rhizome of Ruscus hyrcanus woronow in patients with chronic venous insufficiency (Grade 1 and 2 hemorrhoids); a randomized, double blind, controlled with placebo study.
Preparation of hydroalcoholic extract of Ruscus hyrcanus ointment and evaluation of therapeutic effect in chronic venous insufficiency (hemorrhoid).
Design
Randomized trial by pseudo random numbers table, double blind with parallel control and intervention groups. Each group contains 30 members.
Settings and conduct
Topical hemorrhoid treatment in patients referring to Razi Hospital in Gaemshahr and Imam Khomeini in Sari, researcher, participant, clinical caregiver and outcome evaluator are blinded in this trial.
Participants/Inclusion and exclusion criteria
Patients older than 18 years with first and second degree hemorrhoids are enrolled. Patients with a history of allergic reactions to the plants of Asparagaceae family; pregnant or breastfeeding; with a history of anorectal surgery or any non-medical treatment of hemorrhoids or any malignancy Will not enter the study.
Intervention groups
Intervention group receive Ruscus extract 2% ointment BD in amount of 1 cm for one month. The control group receive placebo ointment in the same way.
Main outcome variables
The amount of permanent pain, pain during defecation, anal bleeding, burning and itching, unpleasantness and amount of strain during defecation are the main consequences.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100107003014N20
Registration date:2018-10-28, 1397/08/06
Registration timing:registered_while_recruiting
Last update:2018-10-28, 1397/08/06
Update count:0
Registration date
2018-10-28, 1397/08/06
Registrant information
Name
Shahram Ala
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1354 3083
Email address
sala@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-11, 1397/06/20
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of therapeutic effects of ointment containing hydro alcoholic extract of root and rhizome of Ruscus hyrcanus woronow in patients with chronic venous insufficiency (Grade 1 and 2 hemorrhoids); a randomized, double blind, controlled with placebo study.
Public title
Effect of hydroalcoholic extract of Ruscus hyrcanus in treatment of chronic venous insufficiency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
at least 18 years old
first and second untreated hemorrhoids
Exclusion criteria:
History of allergic reactions to plants in this family
Pregnancy and Lactation
History of any anorectal surgery and non-pharmacological treatment of hemorrhoids
Ascetic, IBD, Inflammation and any illness that causes rectal bleeding
Thrombosis or external hypersensitivity of the hemorrhoid
Fissure or anal fistula
Hemorrhoids Grade 3 and 4
Anal abscess, port hypertension
Renal failure and any malignancy
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done through a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Ointments made in "placebo" and "Drug" groups, are numbered in the list by the supervisor. After prescribing by the physician, the code of prescribed ointment will be entered into the questionnaire. Physician, Patient and investigator are not aware of the type of ointment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical
Street address
moalem sq.vice chancelor of research, MAZUMS
City
Sari
Province
Mazandaran
Postal code
33971- 48157
Approval date
2018-06-21, 1397/03/31
Ethics committee reference number
IR.Mazums.Rec.1397.1573
Health conditions studied
1
Description of health condition studied
Hemorrhoids grade 1
ICD-10 code
K64.0
ICD-10 code description
First degree hemorrhoids
2
Description of health condition studied
Hemorrhoids grade 2
ICD-10 code
K64.1
ICD-10 code description
Second degree hemorrhoids
Primary outcomes
1
Description
Permanent pain
Timepoint
Measuring the amount of pain at the beginning of the study, the first week, the second, third and fourth weeks after the start of the study, is evaluated and recorded.
Method of measurement
Visual Analogue Scale
2
Description
Pain during defecation
Timepoint
Measuring the amount of pain at the beginning of the study, the first week, the second, third and fourth weeks after the start of the study, is evaluated and recorded.
Method of measurement
Visual analogue Scale
3
Description
Anal bleeding
Timepoint
Measuring the amount of bleeding at the beginning of the study, the first week, the second, third and fourth weeks after the start of the study, is evaluated and recorded.
Method of measurement
Visually and classified as: bloodless (0), low (1), moderate (2) and high (3)
4
Description
strain during defecation
Timepoint
Measuring the amount of strain at the beginning of the study, the first week, the second, third and fourth weeks after the start of the study, is evaluated and recorded.
Method of measurement
Mental scaling: defecation without strain(0), low(1), intermediate(2), high (3)
5
Description
Burning and itchy and unpleasant
Timepoint
Measuring the amount of Burning and itching at the beginning of the study, the first week, the second, third and fourth weeks after the start of the study, is evaluated and recorded.
Method of measurement
Visual analogue Scale
Secondary outcomes
1
Description
Side effect during treatment
Timepoint
The type of side effect measured during treatment at the first, second, third and fourth week after the start of treatment.
Method of measurement
observation and according to questionnaire
Intervention groups
1
Description
Intervention group: Ruscus extract 2% ointment/ 2 times daily/ 1 cm of the ointment/ For one month
Category
Treatment - Drugs
2
Description
Control group: ointment formolation without any drugs/ 1 cm of the ointment/ For one month