The efficacy of Proscure on dysmenorrhea in endometriosis
Design
It is a double-blind clinical and random astrology. Phase Three Clinical Studies. Women aged 20-45 years referred from a specialized endometriosis clinic by a gynecologist with a complaint
Pain. Patients are divided into intervention and control groups based on a table of random numbers (prepared by a statistician).
Drugs and placebo are given to patients in thirty packs for three months
Becomes. Two a day, one in the morning, one at night for 90 days.
Settings and conduct
Rasoul Akram Hospital is a traditional medicine clinic.
Drugs and placebo are given to patients in thirty packs for three months
Becomes.
At the beginning of the study, the VAS questionnaire for patients' pain (including dysmenorrhea, dyspareunia, and chronic non-menstrual pelvic pain and pain) was filled out and once at the end.
30 days of treatment and once at the end of 60 days and then after 90 days) at the end of the study (the questionnaire is filled out again).
The endometriosis clinic will be referred.
Participants/Inclusion and exclusion criteria
Women aged 20 to 45 years
Definitive diagnosis of endometriosis
Not intending to become pregnant
Degree of pain caused by more or less alignment
No breastfeeding
Lack of emergency medical care
Referral from a gynecologist
Intervention groups
Proscure in intervention group
Placebo in control group
Main outcome variables
Dyspareunia
Dysmenorrhea
Quality of Life
Pelvic pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211201053241N1
Registration date:2022-01-01, 1400/10/11
Registration timing:registered_while_recruiting
Last update:2022-01-01, 1400/10/11
Update count:0
Registration date
2022-01-01, 1400/10/11
Registrant information
Name
Elham Akhatri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5563 9667
Email address
eli.akhtari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-21, 1400/09/30
Expected recruitment end date
2022-06-20, 1401/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Proscure capsule on dysmenorrhea in known cases of endometriosis
Public title
Efficacy of Proscure on dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definite diagnosis of Endometriosis
Gynecological refer
VAS bigger than or equal 3
No need to emergency management
Age between 20-45
Exclusion criteria:
Wish to pregnancy in 3 months later
breast feeding
need to emergency
no attempt to herbal medicine
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
First, people are divided into two groups: moderate and severe. Then in each category, randomization is done by block method. First, 4 blocks of A and B are written. Then, with the help of a random number table (Excel program), the blocks are randomly selected and lined up side by side to complete the desired sample size. A random list is provided to the person performing the illness. The patient and the person receiving the disease are not aware of the type of drug A and B, and the placebo drug is similar in appearance. Also, the data analyzer is not aware of types A and B (three-way blind study). For allocation concealment, letter envelopes are used in the package so that the number of the person referring to the envelope and the type of medicine he should receive is written in the envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
The table of random numbers prepared by a respected statistical expert is available to the researcher. The medicine and placebo packs are packaged in a similar way and the table numbers are repeated and recorded on them and the consulting pharmacist is in the process of this packaging. In this way, with the arrival of the patient who fills in the forms, the pack is followed by the relevant number delivered.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
University of Persian Medicine, Behesht Street, Vahdat eslami Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1114733311
Approval date
2021-11-21, 1400/08/30
Ethics committee reference number
IR.IUMS.REC.1400.783
Health conditions studied
1
Description of health condition studied
Endimetriosis
ICD-10 code
N80.0
ICD-10 code description
Endometriosis of uterus
Primary outcomes
1
Description
Dysparunia based on VAS questionare
Timepoint
The beginning of the study and then the end of the study at the end of three months of treatment
Method of measurement
VAS questionaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Women 20 to 45 years old with dysmenorrhea due to endometriosis; The intervention is the prescription of Proscore drug produced by Gol Daroo company that the patient consumes morning and night in clean days. First, the pain and quality of life questionnaire is filled in by the therapist, then the package containing the medicine is delivered, the patient is visited every 4 weeks until the three menstrual cycles, and finally the questionnaires will be filled in again.
Category
Treatment - Drugs
2
Description
Control group: Women 20 to 45 years old with dysmenorrhea due to endometriosis; The intervention is the prescription of Proscore drug produced by Gol Daroo company that the patient consumes morning and night in clean days. First, the pain and quality of life questionnaire is filled in by the therapist, then the package containing the medicine is delivered, the patient is visited every 4 weeks until the three menstrual cycles, and finally the questionnaires will be filled in again.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Elham Akhtari
Street address
Persian Medicine School, Behasht Ave. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5563 9667
Email
eli.akhtari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Majid Dadmehr
Street address
Persian Medical School, Behasht Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5563 9667
Email
eli.akhtari@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elham Akhtari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Persian Medicine school, Behesht Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5563 9667
Email
Eli.akhtari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elham Akhtari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Persian Medicine School, Behesht Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5563 9667
Email
Eli.akhtari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elham Akhtari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Persian Medicine School, Behesht Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
114733311
Phone
+98 21 5563 9667
Email
Eli.akhtari@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after identifying individuals.
When the data will become available and for how long
Access starts six months after printing the results
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
For sample use in larger studies
From where data/document is obtainable
Email the scientific interface of the project called Elham Akhtari
What processes are involved for a request to access data/document
An email will be sent and it will be done within a week.