Evaluation the effectiveness of the Curcumin as add-on to dienogest in patients with endometriosis
Design
After collecting the data, in the first stage, basic clinical and demographic variables will be compared in the intervention and control groups. To compare the mentioned variables, independent t-test, chi-square and Fisher's exact test are used according to the type of variable and the assumptions of the mentioned tests. The method of analysis in this study will be analysis by intention to treat. Multiple imputation method will be used to estimate the missing data. In order to analyze the primary and secondary outcomes of the study, the mixed-effects linear regression statistical test will be used. The results will be calculated and reported as adjusted mean difference with 95% confidence. The variables included in the model include all the variables affecting the outcome, which have been proven in the literature review. A significance level of 0.05 will be considered in all tests. Stata statistical software version 16 will be used for data analysis.
Settings and conduct
All women referred to Ali Bin Abi Taleb (AS) Zahedan Hospital diagnosed with endometriosis and candidates for the prescription of Dingest without previous history of taking hormonal agents.
Participants/Inclusion and exclusion criteria
Women aged 18 to 45 with pain related to endometriosis proven by sonography and examination and history and candidates to receive Dynogest and without previous history of taking hormonal agents.
Intervention groups
Curcumin and dienogest
Main outcome variables
1-the pain
2- Endometrioma size
3- Quality of Life
4- sexual function
5- Housing consumption
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221111056469N1
Registration date:2022-11-16, 1401/08/25
Registration timing:prospective
Last update:2022-11-16, 1401/08/25
Update count:0
Registration date
2022-11-16, 1401/08/25
Registrant information
Name
Mahjob Sargazi taghazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 640 0960
Email address
mahjobsargazi.taghazi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-06, 1401/09/15
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effectiveness of the Curcumin as add-on to dienogest in patients with endometriosis.
Public title
Effectiveness of curcumin in endometriosis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 18 to 45 years experiencing pain associated with endometriosis proven by ultrasound and examination and history
No previous history of using hormonal agents
Candidate to receive dinogest
Exclusion criteria:
Pregnancy or breastfeeding
Amenorrhea
The need for surgery after the intervention
Previous use of hormonal agents (such as GnRH agonists for 6 months, progestins, dienogest or danazol for 3 months or oral contraceptives for 1 month before the intervention)
Abnormal findings in women's examination
Abnormal cervical cytology smear in the last 3 months
Taking narcotic painkillers before surgery on a daily basis for 2 weeks before surgery
Additional surgeries performed or malignancy
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Sample size is 86 people, of which 43 people will be placed in each group. The block random allocation method was designed by an epidemiologist using WWW.Sealedenvelop.com. The number of considered blocks is 6.
Blinding (investigator's opinion)
Double blinded
Blinding description
The list of random allocation of patients will only be at the disposal of the plan's epidemiologist. In order to hide the random allocation process, random 10-digit codes are written on 86 paper labels without a specific order and framework, which is the identification number of the relevant treatment and only the project methodologist will be aware of the relevant code. The labels will be stuck on the medicine packages in the order of the randomization list. Medicine packages will be arranged in the order of the randomization list inside the box. When the doctor declares the eligibility of a patient, the methodologist will provide the patient with the package treatment plan. The person evaluating the intended outcomes is a third person who is unaware of the randomization process and the type of treatment performed. In order to analyze the data, a statistician who is separate from the study process and is unaware of all the processes will be used.
The list of random allocation of patients will only be at the disposal of the plan's epidemiologist. In order to hide the random allocation process, random 10-digit codes are written on 86 paper labels without a specific order and framework, which is the identification number of the relevant treatment and only the project methodologist will be aware of the relevant code. The labels will be stuck on the medicine packages in the order of the randomization list. Medicine packages will be arranged in the order of the randomization list inside the box. When the doctor declares the eligibility of a patient, the methodologist will provide the patient with the package treatment plan. The person evaluating the intended outcomes is a third person who is unaware of the randomization process and the type of treatment performed. In order to analyze the data, a statistician who is separate from the study process and is unaware of all the processes will be used.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Sistan and Baluchestan Province, Zahedan, Integrating the campus of the University of Medical Sciences، doctor، Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2022-10-25, 1401/08/03
Ethics committee reference number
IR.ZAUMS.REC.1401.285
Health conditions studied
1
Description of health condition studied
Endometriosis
ICD-10 code
N80
ICD-10 code description
Endometriosis
Primary outcomes
1
Description
Score Of The Quality of life questionnaire
Timepoint
At the beginning of the study (before the start of the intervention) and 2 months later.
Method of measurement
Specific Questionnaire of Quality of Life in Endometriosis Patient(Endometriosis Health Profile-30)
2
Description
Sexual performance score in the questionnaire
Timepoint
At the beginning of the study (before the start of the intervention) and 2 months later.
Method of measurement
Female Sexual Function index
3
Description
Endometrioma lesion Size
Timepoint
At the beginning of the study (before the start of the intervention) and 2 months later.
Method of measurement
Ultrasound and Medical Examination
4
Description
Pain Score in the Questionnaire
Timepoint
At the beginning of the study (before the intervention) and 2 months later
Method of measurement
Pain Visual Analog Scale Questionnaire
Secondary outcomes
1
Description
Pain Score in the Questionnaire
Timepoint
At the beginning of the study (before the intervention) and 2 months later
Method of measurement
Pain Visual Analog Scale Questionnaire
2
Description
Sexual performance score in the questionnaire
Timepoint
At the beginning of the study (before the intervention) and 2 months later
Method of measurement
Female Sexual Function Index
3
Description
Quality of life score in the questionnaire
Timepoint
At the beginning of the study (before the intervention) and 2 months later
Method of measurement
Specific Questionnaire of Quality of life in Endometriosis Patient(Endometriosis Health Profile-30)
4
Description
Endometrioma lesion size
Timepoint
At the beginning of the study (before the intervention) and 2 months later
Method of measurement
Ultrasound and medical examination
Intervention groups
1
Description
Control group: Control group: control group (dienogest and placebo) will receive a dose of 2 mg of dienogest daily along with placebo.
Category
Placebo
2
Description
Intervention group: Intervention group: Patients in the intervention group (Dinogest and curcumin) will receive a dose of 2 mg dinogest daily. According to the panel of the European Food Safety Authority, the acceptable dose of curcumin is 3 mg per kilogram of body weight. be Patients in the intervention and control groups are prescribed the prescribed dose based on the patient's weight and the frequency of daily use. During the treatment, nanomicelle curcumin 80 and 40 mg of Sinacurcumin company is used.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abi Talib Hospital, Zahedan
Full name of responsible person
Dr.Maryam Razavi
Street address
Persian Gulf Highway-Salamat Blvd-Ali Ibn Abi Talib (AS) Superspeciality Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
public@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Nur Mohammad Bakhshani
Street address
Zahedan - Doctor Hasabi Square - Medical Sciences Campus
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
public@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Mahjob Sargazi Taghazi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zebashahr - Nasr Street - 18 Nasr - Middle of Milan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817979699
Phone
+98 54 3348 9817
Email
Mahjobsargazi.taghazi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahjob Sargazi Taghazi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zibashahr-Nasr-Nasr 18- Mid Milan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817979699
Phone
+98 54 3348 9817
Email
Mahjobsargazi.taghazi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahjob Sargazi Taghazi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zebashahr - Nasr Street - 18 Nasr - Middle of Milan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817979699
Phone
+98 54 3348 9817
Email
Mahjobsargazi@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