Comparison of the effect of herbal medicine package in the treatment of endometriosis patients
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 60 patients. The rand function of the Excel software was used for randomization.
Settings and conduct
In this study, patients with ovarian endometriomal cysts less than 80 mm in size were referred to a gynecology clinic and referred to a sonography clinic by a gynecologist. After obtaining conscious consent and having the criteria to enter the study, the mentioned patients will be examined as the target community. Patients will be randomly divided into two groups by block method.
In addition to routine OCP treatment, the intervention group receives a combination of herbal medicines.
Group B: In addition to OCP treatment, patient receives a routine placebo.
After the initial sonography of the uterus to determine the size of the endometriomal cyst and the presence or absence of dysmenorrhea, as well as other symptoms related to the disease, the Iranian medicine specialist provides the patients with the drug. Information is recorded. Finally, the data are compared before and after the intervention.
It should be noted that ultrasound is performed by a radiology assistant.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
15 to 49 years
Having endometriosis and ovarian endometriosis
Exclusion criteria
Dissatisfaction
Having cardiovascular disease
Low platelets
Pregnancy or lactation
Diabetes
History of uterine cancer in the individual or his relatives
Intervention groups
Patients with ovarian endometrioma
Main outcome variables
If we can achieve results, we can use the combination of herbal medicines to help patients and reduce the use of previous drugs and help improve the quality of life of patients with endometriosis.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200701047981N1
Registration date:2020-07-22, 1399/05/01
Registration timing:registered_while_recruiting
Last update:2020-07-22, 1399/05/01
Update count:0
Registration date
2020-07-22, 1399/05/01
Registrant information
Name
Mohamad Manoosian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3333 6421
Email address
mohamadmanoosian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-20, 1399/04/30
Expected recruitment end date
2020-07-31, 1399/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Ultrasonographic study of the effects of herbal medicine package on Endometriosis
Public title
Effects of herbal medicine on endometriosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 15 to 49 years old
Endometrial disease with ovarian endometrioma
Exclusion criteria:
Dis-satisfaction
Cardiovascular disease
Thrombocytopenia
Pregnancy / breast feeding
Patient with uterus malignancy history or having history in the first degree family
Diabetes mellitus
Age
From 15 years old to 49 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of individual blocks using rand function Excel software. The size of the blocks is 4.
Blinding (investigator's opinion)
Double blinded
Blinding description
The radiology assistant, who is also the lead researcher and evaluator of the outcome, along with the participants in the study, as well as the clinical caregiver who specializes in Iranian medicine, as well as the analyst, are all blind. The same package is randomly provided to patients without knowing the contents of the package.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Alam al-Huda St., Shahid Shiroodi St.
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2020-06-14, 1399/03/25
Ethics committee reference number
IR.ARAKMU.REC.1399.108
Health conditions studied
1
Description of health condition studied
Endometriosis
ICD-10 code
N80.1
ICD-10 code description
Endometriosis of ovary
Primary outcomes
1
Description
Ovarian endometrimal cyst size
Timepoint
At the beginning of the study and 3 months after starting the package of herbal medicines
Method of measurement
Ultrasonography
Secondary outcomes
1
Description
Dysmenorrhea
Timepoint
At the beginning of the study and 3 months after starting the package of herbal medicines
Method of measurement
Asking patient (yes/ no)
2
Description
Pelvic pain
Timepoint
At the beginning of the study and 3 months after starting the package of herbal medicines
Method of measurement
Asking patient (yes/ no)
3
Description
Dysparonia
Timepoint
At the beginning of the study and 3 months after starting the package of herbal medicines
Method of measurement
Asking patient (yes/ no)
4
Description
Dysuria
Timepoint
At the beginning of the study and 3 months after starting the package of herbal medicines
Method of measurement
Asking patient (yes/ no)
5
Description
Spotting
Timepoint
At the beginning of the study and 3 months after starting the package of herbal medicines
Method of measurement
Asking patient (yes/ no)
6
Description
Hypermenorrhea
Timepoint
At the beginning of the study and 3 months after starting the package of herbal medicines
Method of measurement
Asking patient (yes/ no)
7
Description
Chronic fatigue
Timepoint
At the beginning of the study and 3 months after starting the package of herbal medicines
Method of measurement
Asking patient (yes/ no)
8
Description
Hematuria
Timepoint
At the beginning of the study and 3 months after starting the package of herbal medicines
Method of measurement
Asking patient (yes/ no)
9
Description
Painful defecation
Timepoint
At the beginning of the study and 3 months after starting the package of herbal medicines
Method of measurement
Asking patient (yes/ no)
Intervention groups
1
Description
Intervention group: in addition to being treated with routine OCP by a gynecologist, two Aslagh capsules of 500 mg are taken on an empty stomach in the morning (half an hour before breakfast) and two tablespoons at the end of the night. They are not taken during menturation. Abdominal anointment with chamomile oil will also be done. The duration of treatment will be three months. Aslagh product ingredients: aslagh, fennel, yellow carrot seeds. Ingredients of syrup product: fennel root and seeds, chicory root and seeds, celery seed, cucumber seed, badrang cucumber seeds, melon seed, vinegar , Water, red sugar
Category
Treatment - Drugs
2
Description
Control group: In addition to routinr OCP treatment prescribed by a gynecologist, which is in the form of a capsule that is similar to the drug (with the coordination of the pharmaceutical company in the same capsules, flour is poured) and to replace the placebo for the drug syrup similar syrup will be is used.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Royan Infertility Treatment Center
Full name of responsible person
Nazila Najdi
Street address
Shahid Beheshti St., Haj Agha Saber Mosque Alley (located behind the mosque), located in the subspecialty center for infertility treatment of Jihad Daneshgahi, Markazi Province
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3278 5550
Email
sec.mr@acecr.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Shahid Shiroodi St. - Alam Al-Huda St.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
info@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mohammad Manoosian
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
Alam al-Huda St., Shahid Shiroodi St.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
mohamadmanoosian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Manoosian
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
Alam al-Huda St., Shahid Shiroodi St.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
mohamadmanoosian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Manoosian
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
Alam al-Huda St., Shahid Shiroodi St.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
mohamadmanoosian@gmail.com
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