The effect of Agnugol on painful symptoms of endometriosis and quality of life
Design
a clinical trial with a control group، parallel groups، triple blind، randomized by block method، phase3، on70patients
Settings and conduct
The place of research in this study is a doctor's office specializing in gynecological diseases in Tabriz city. A written informed consent will be obtained and a questionnaire of painful menstrual symptoms and quality of life specific to patients with endometriosis will be completed before allocation into groups. Then, the participants will be randomized using a random block method with a block size of four and with an allocation ratio of 1:1 They will be assigned to two groups of intervention (recipient of Agnugol tablets) and control (recipient of placebo). Allocation sequence will be done by someone not involved in sampling and data collection. Agnugol and placebo tablets will be prepared by Gol Daru pharmaceutical company in a completely similar way.
This study is a three -way blind trial in wich the researcher, the participant and the analyst will not know ehich group the person is in.
Participants/Inclusion and exclusion criteria
inclusion
women with endometriosis
women in the age range of 18-49
women married and sexually active woman
exclusion
taking anti-inflammatory and hormonal drugs
allergy to medicinal plants of the lamiaceae
suffering from digestive diseases
Intervention groups
For the intervention group, Agnugol tablet with a dose of3.2 – 4.8mg and for the control group, placebo with the same dose will be given twice a day for 8 weeks.
Main outcome variables
8 weeks after the start of the intervention, participants will complete again painful menstrual symptoms and quality of life specific to patients with endometriosis.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180404039187N11
Registration date:2023-07-29, 1402/05/07
Registration timing:registered_while_recruiting
Last update:2023-07-29, 1402/05/07
Update count:0
Registration date
2023-07-29, 1402/05/07
Registrant information
Name
Elnaz Shaseb
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 2250
Email address
shasebe@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Agnugol on painful symptoms of endometriosis and quality of life: a randomized clinical trial
Public title
The effect of Agnugol on painful symptoms of endometriosis and quality of life
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with endometriosis whose disease has been diagnosed based on clinical symptoms and imaging (sonography) as well as previous documented evidence of endometriosis.
Women with symptomatic endometriosis.
Women who are in the age range of 18-49 years.
They have not taken anti-inflammatory or hormonal drugs in the last three months.
Don't have endometrial hypoplasia or neoplasia.
Women who are married and sexually active.
Exclusion criteria:
Women who are allergic to medicinal plants, especially the Lamiaceae family.
Women suffering from gallstones, jaundice due to biliary obstruction and acute biliary colic.
Women with digestive diseases.
Women who suffer from inflammatory diseases or diseases associated with immune system defects such as rheumatoid arthritis, lupus, multiple sclerosis, etc.
Age
From 18 years old to 49 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be assigned to two groups of intervention (recipient of Agnugol tablets) and control (recipient of placebo) by random block method with the size of blocks of four and with allocation ratio of 1:1. Allocation sequence will be done by someone not involved in sampling and data collection.
Arrangement of the randomization process:
1) Determining the volume of each block (quadruple blocks)
2) Preparing the list of the blocks and assigning a number to each of them
AABB(1) ABAB(2) ABBA(3) BBAA(4) BABA(5) BAAB(6)
3) Choosing random numbers between 1 and 6
4) Defining the treatment assignment list
For example: AABB(1)_BBAA(4)_ABAB(2)_BABA(5)
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study is a three -way blind trial in which the researcher, the participant and the analyst will not know each group the person is in.
The participant will be assigned to two intervention groups(recipients of Agnugol) and control groups(recipients of placebo). Allocation sequence will be done by someone not involved in sampling and data collection. to conceal the allocation, the drug and placebo will be numbered and packed in the same container and consecutively.
At the researcher level, blindness will be done as the researcher give the medicine to patients on the basis of label A or B without knowing the nature of A, B and according to the randomized list. At the patient's level, blindness will be done as the patients do not know in which group (control or intervention group) they are in. At the analyst level, blindness will be done as analyst will analyze the data without knowing the intervention and control group.
Placebo
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
Research and technology dept, central building No.2, third floor, tabriz university of medical sciences, golgasht St, tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2022-11-01, 1401/08/10
Ethics committee reference number
IR.TBZMED.REC.1401.696
Health conditions studied
1
Description of health condition studied
endometriosis
ICD-10 code
N74.8
ICD-10 code description
Female pelvic inflammatory disorders in other diseases classified elsewhere
Primary outcomes
1
Description
quality of life of endometriosis patients
Timepoint
before investigation and 8 weeks after investigation
Method of measurement
questionnaire 30-EHP
2
Description
symptoms of pelvic pain and gynecology
Timepoint
before investigation and 8 weeks after investigation
Method of measurement
questionnaire ENDOPAIN-4D
Secondary outcomes
1
Description
pain
Timepoint
the first 3 days of the next 3 menstrual cycles
Method of measurement
VAS ruler
Intervention groups
1
Description
Agnugol tablet recipient at a dose of 3.2-4.8 mg once a day for 8 weeks
Category
Treatment - Drugs
2
Description
placebo tablet recipient at the same dose and appearance once a day for eight weeks