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Comparing the effects of Berberine, Curcumine and gonadotropin-releasing hormone agonist (GnRH) on uterine leiomyoma volume , a controlled, randomized clinical trials

Protocol summary

Study aim
Comparison of the effect of curcumin and berberine and gonadotropin-releasing hormone (GnRH) agonists on uterine myoma size and hormonal changes and hot flashes
Design
Clinical trial in three parallel groups, not blinded, randomized, phase 3 on 102 patients. To randomize permutation blocks
Settings and conduct
Women aged 18 to 45 years who have a uterine myoma larger than 5 cm and if there are more, other myomas are smaller than 2 cm and refer to the clinic of Amir Al-Momenin Hospital in Semnan. According to the admission criteria, 102 patients will be randomly assigned using the randomized permutation block method and will be divided into three groups treated with curcumin, berberine and leoporline. After identifying the myoma with vaginal ultrasound, its volume is performed at the beginning and at weeks 6 and 12, and their average is also calculated. Serum samples (FSH, LH, E2) is measured at baseline and at 12 weeks after starting treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women 18 to 45 years old have a myoma larger than 5 cm that has another myoma (s) (if any) less than 2 cm in size - Exclusion criteria: 1) Women with extra myoma (s) greater than or equal to 2 cm or myoma with a size of 2-5 cm 2) Women who have been treated with any type of estrogen or progesterone in less than one month, hormonal implants in the last 3 months, any type of antihypertensive drug, have had major medical disease, previous treatment or surgery for myoma or during the study Complications have been reported
Intervention groups
Patients with uterine myoma who have referred to the gynecological clinic of Amir Al-Momenin Hospital and are treated with curcumin, berberine and leoporline in three groups
Main outcome variables
Uterine myoma size, LH, FSH, E2

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220201053908N1
Registration date: 2022-02-23, 1400/12/04
Registration timing: prospective

Last update: 2022-02-23, 1400/12/04
Update count: 0
Registration date
2022-02-23, 1400/12/04
Registrant information
Name
Elham Akbari Vafaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3346 0066
Email address
elak_ir222@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-06, 1400/12/15
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of Berberine, Curcumine and gonadotropin-releasing hormone agonist (GnRH) on uterine leiomyoma volume , a controlled, randomized clinical trials
Public title
Comparing the effects of Berberine, Curcumine and gonadotropin-releasing hormone agonist (GnRH) on uterine leiomyoma volume
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non-menopausal women between the ages of 18 and 45, who have a myoma larger than 5 cm that have abnormal uterine bleeding, pelvic pain, dysmenorrhea, and a compressive effect. Women with myomas larger than or equal to 5 cm who have other myomas (s) less than 2 cm in size
Exclusion criteria:
Women with extra myoma (s) greater than or equal to 2 cm Women with uterine myoma who have been treated with any type of estrogen or progesterone in less than a month and hormonal implants in the last 3 months Women with a history of major medical illness and / or previous drug or surgical treatment of uterine leiomyomas All women with myomas 2-5 cm in size were excluded from the study Patients receiving antihypertensive drugs, beta-blockers and calcium channel blockers, and ACE inhibitors were excluded from the study due to possible drug interactions Patients who develop side effects during the study will be excluded from the study
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment will be done using the randomized permutation block method. The three study groups are named A, B and C and are written randomly in triplicate blocks and the order list of groups is provided to us. This will be done by a statistical study consultant who is not present at the clinical trial.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Siences
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini St., Imam Hossein Square
City
Semnan
Province
Semnan
Postal code
3519734731
Approval date
2022-01-24, 1400/11/04
Ethics committee reference number
Ir.semums.rec.1400.304

Health conditions studied

1

Description of health condition studied
Uterine myoma
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Uterine myoma size
Timepoint
At the beginning of the study and 6 and 12 weeks after starting treatment
Method of measurement
Vaginal ultrasound machine

Secondary outcomes

1

Description
LH hormon
Timepoint
At the beginning of the study and 12 weeks after treatment
Method of measurement
RIA laboratory method

2

Description
FSH hormon
Timepoint
At the beginning of the study and 12 weeks after treatment
Method of measurement
RIA laboratory method

3

Description
Estradiol hormon
Timepoint
At the beginning of the study and 12 weeks after treatment
Method of measurement
RIA laboratory method

Intervention groups

1

Description
Intervention group: The first group treated with curcumin, each tablet contains 450mg of turmeric rhizome powder and 50mg of turmeric extract, which is standardized based on 5.47mg of curcumin. Once a day, one tablet, made by Dineh Company
Category
Treatment - Drugs

2

Description
Intervention group: The second group treated with berberine capsule, 1000mg pure berberine extract extracted from barberry plant. One capsule twice a day, Omid Parsina Damavand Company
Category
Treatment - Drugs

3

Description
Control group: The third group treated with leuprorelin acetate in the form of an ampoule containing 3.75 mg of leuprorelin acetate by subcutaneous or intradermal injection of one dose per month, made by Varian Pharmed Company
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Al-Momenin Hospital
Full name of responsible person
Elham Akbari
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini St., Imam Hossein Square
City
Semnan
Province
Semnan
Postal code
3519734731
Phone
+98 23 3346 0055
Email
amir.hospital@semums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr majid mir mohammadkhani
Street address
Vice Chancellor for Research and Technology, Headquarters of Semnan University of Medical Sciences, Basij Blvd.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
rds@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Elham saffarieh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Amir Al-Momenin Hospital, Shahid Mostafa Khomeini Boulevard, Imam Hossein Square
City
Semnan
Province
Semnan
Postal code
3519734731
Phone
+98 23 3346 0055
Email
eli_saffarieh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Elham saffarieh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Amir Al-Momenin Hospital, Shahid Mostafa Khomeini Boulevard, Imam Hossein Square
City
Semnan
Province
Semnan
Postal code
3519734731
Phone
+98 23 3346 0055
Email
eli_saffarieh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Elham Akbari Vafaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Amir Al-Momenin Hospital, Shahid Mostafa Khomeini Boulevard, Imam Hossein Square
City
Semnan
Province
Semnan
Postal code
3519734731
Phone
+98 23 3346 0055
Email
elak_ir222@yahoo.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
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