Protocol summary

Study aim
Considering the prevalence of endometriosis and its debilitating symptoms and complications, which can affect the psychosocial parameters of a society by reducing the quality of life. By using drugs such as di-chiro-inositol, it is possible to help reduce the pain and complications of this disease by reducing the production of estrogen.
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 100 patients. The rand function of Excel software was used for randomization.
Settings and conduct
Patients referring to Taleghani Hospital's gynaecology Clinic, receiving drug packages, patients and caregivers are blinded
Participants/Inclusion and exclusion criteria
Criteria for entering : age : between 20 and 40 years, refusal to receive other standard treatments pelvic pain that has been present for at least the last three months, diagnosis of endometriosis systemic estradiol higher than 90 pg/ml in the first 4 days after the end of the period, consent to start the plan and exclusion criteria from the plan: BMI>30), history of diabetes, history of tumors Secretion, use of hormones or inositol within 6 months before starting the study, use of other drugs, especially (OCP and...), any disease that interferes with the use of di chiro inositol, pregnancy/lactation
Intervention groups
In this RCT study, patients referring to the gynecology clinic, whose endometriosis has been confirmed using transvaginal ultrasound, will be determined and randomly divided into two equal groups. The goals and results obtained are discussed and an attempt is made to obtain the consent of the patients to participate in the study. A written consent is obtained from the patients who agree to participate. Then, the case and control groups are given separate medication packages.
Main outcome variables
dyspareunia; dysmenorrhea; pelvic pain; age; BMI; dyschezia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230111057113N1
Registration date: 2023-02-23, 1401/12/04
Registration timing: registered_while_recruiting

Last update: 2023-02-23, 1401/12/04
Update count: 0
Registration date
2023-02-23, 1401/12/04
Registrant information
Name
Samaneh Esmaeili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4435 2355
Email address
dresmaeili@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-21, 1401/12/02
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy of D-Chiro-Inositol in pain relif in endometriosis
Public title
Evaluation the efficacy of D-Chiro-Inositol in endometriosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 and 40 years old Diagnosis of endometriosis Refusal to use other standard therapies Systemic estradiol >90 pg/ml during the first 4 days after the end of menstrual cycle. informed consent to entry Pelvic pain that has been present for at least three months
Exclusion criteria:
Diagnosis of secreting tumors previous history of Diabetes Melitus BMI>30 Taking hormones or inositol within 6 months before starting the study Using other drugs, especially (OCP and...) Any disease that interferes with the use of D-chiroinositol
Age
From 20 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly given a sealed envelope containing medicine
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be randomly divided into two equal groups.The patients are discussed about the research plan and the method, the goals and the results obtained and An attempt is made to obtain the consent of the patients to participate in the study.Written consent is obtained from patients who agree to participate and Then they will be divided into case and control groups.In a random and double-blind manner, the medicine packages will be distributed by the doctor between the two groups
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Taleghani hospital, Next to Shahid Beheshti University of Medical Sciences,Shahid Arabi St ,Yemen St, Chamran Highway,Tehran
City
،ehran
Province
Tehran
Postal code
1985711151
Approval date
2023-02-20, 1401/12/01
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.751

Health conditions studied

1

Description of health condition studied
Endometriosis is characterized by the presence of endometrial and stromal tissue outside the uterine cavity
ICD-10 code
N80
ICD-10 code description
Endometriosis

Primary outcomes

1

Description
Pelvic pain
Timepoint
At the beginning of the study, one month after the start of treatment, 6 months after the start of treatment
Method of measurement
VAS score

Secondary outcomes

1

Description
Pelvic pain
Timepoint
At the beginning of the study, one month after the start of treatment, 6 months after the start of treatment
Method of measurement
VAS score

2

Description
Dyspareunia
Timepoint
At the beginning of the study, one month after the start of treatment, 6 months after the start of treatment
Method of measurement
Vas score

3

Description
Dysmenorrhea
Timepoint
At the beginning of the study, one month after the start of treatment, 6 months after the start of treatment
Method of measurement
Vas score

4

Description
Dyschezia
Timepoint
At the beginning of the study, one month after the start of treatment, 6 months after the start of treatment
Method of measurement
Vas score

Intervention groups

1

Description
Intervention group: two tablets containing 1200 mg of DCI and 120 mg of alpha-lactalbumin for the first month and 600 mg of DCI and 60 mg of alpha-lactalbumin for the next 5 months.
Category
Treatment - Drugs

2

Description
Control group: Control group: tablets containing 600 mg of maltodextrin daily for 6 months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital
Full name of responsible person
Sagar Salehpour
Street address
Taleghani Hospital ,Next to Shahid Beheshti University of Medical Sciences,- Shahid Arabi St, Yemen St, Shahid Chamran Highway,Tehran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Fax
+98 21 2243 2570
Email
dresmaeili@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology
Street address
Taleghani Hospital,Next to Shahid Beheshti University of Medical Sciences,Shahid Arabi St,Yemen St ,Shahid Chamran Highway ,Tehran
City
tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Fax
+98 21 2243 2570
Email
dresmaeili@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
20
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Samaneh Esmaeili
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Taleghani Hospital,Next to Shahid Beheshti University of Medical Sciences,Shahid Arabi St,Yemen St ,Shahid Chamran Highway ,Tehran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
dresmaeili@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Samaneh Esmaeili
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Taleghani Hospital,Next to Shahid Beheshti University of Medical Sciences,Shahid Arabi St,Yemen St ,Shahid Chamran Highway ,Tehran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
dresmaeili@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Samaneh Esmaeili
Position
Consultant,
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Taleghani Hospital,Next to Shahid Beheshti University of Medical Sciences,Shahid Arabi St,Yemen St ,Shahid Chamran Highway ,Tehran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
dresmaeili@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
Yes - There is 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
Only a part of the data, such as the information related to the main result or the like, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
For scientific studies and therapeutic use
From where data/document is obtainable
Samaneh Esmaeili،dresmaeili@gmail.com
What processes are involved for a request to access data/document
Within a month of receiving the email
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