Protocol summary

Study aim
Comparison of the effect of herbal medicine treatment with Achillea Cretica and Dinogest on pain and size of endometrial lesions in patients with endometriosis.
Design
The clinical trial has an intervention and control group, with parallel, double-blind, randomized groups based on 4-size two-allele random number blocks, phase 3, on at least 70 patients.
Settings and conduct
The patient is unaware of the type of treatment received. The final results of the study will be reviewed by a physician who is unaware of the type of intervention. For statistical analysis, a statistician who does not know how to assign individuals to groups is used. The random assignment list of patients is only at the disposal of the clinic secretary. When the physician declares a patient eligible, the clinic secretary provides the envelope to the physician and the treatment is performed according to the type mentioned in the envelope.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women aged 18 to 45 years with pain associated with endometriosis. Exclusion criteria include pregnancy or lactation, amenorrhea within 3 months prior to enrollment, need for endometriosis surgery, previous use of hormonal agents, abnormal findings on gynecological examination, risk factors for decreased bone density
Intervention groups
Patients referred to the laparoscopic clinic of Arsh Hospital who are eligible to enter, if admitted with satisfaction. They are divided into two groups using the randomization block method. The first group receives 2 grams of Dinogest tablets daily for 3 months with rice syrup and the second group receives 2 grams of Dinogest tablets daily with placebo syrup for 3 months.
Main outcome variables
Evaluation of dysmenorrhea, dyspareunia, pelvic pain, and change in size and number of endometriosis lesions in patients

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220408054455N1
Registration date: 2022-07-27, 1401/05/05
Registration timing: registered_while_recruiting

Last update: 2022-07-27, 1401/05/05
Update count: 0
Registration date
2022-07-27, 1401/05/05
Registrant information
Name
Soheila Sadat Moosavifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 633 5414
Email address
soheilamoosavifar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-06, 1401/04/15
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Achillea Cretica herbal treatment with Dinogest on the pain and size of endometriosis lesions in patients referred to Arash Hospital.
Public title
The effect of Achillea Cretica herbal medicine on pain and size of endometrial lesions in patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women 18 to 45 years old with pain associated with endometriosis
Exclusion criteria:
Pregnancy Breastfeeding The need for endometriosis surgery treatment Amenorrhea within 3 months prior to enrollment Previous use of hormonal agents (e.g., gonadotropin agonists less than 6 months ago, progesterone or danazol less than 3 months ago, or oral contraceptives 1 month before screening) Abnormal findings in gynecological examination Risk factors for decreased bone density (e.g., family history of osteoporosis or use of anticonvulsants or corticosteroids)
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Our sample size is 80 people, with 40 people in each group. We will use the block randomization method by using: www.sealedenvelope.com. The number of blocks considered is 4.
Blinding (investigator's opinion)
Double blinded
Blinding description
The random assignment list of patients is only available to the clinic secretary. To hide the random allocation process, the treatment sequence card is written in order, then the cards will be placed in sealed envelopes. On each envelope, a random 10-digit code is written without order and frame, which is the relevant patient identification number, and only the design methodologist will be aware of the relevant code. When the doctor announces that a patient is eligible, the clinic secretary provides the envelope to the physician and the desired treatment is performed according to the type mentioned in the envelope Patients do not know the type of syrup they receive and one group is given a placebo and the other group is given medicine. The final results of the study will be reviewed by a physician who is unaware of the type of intervention. For statistical analysis, a statistician who does not know how to assign individuals to groups is used.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of school medicine, Tehran University of Medical Science
Street address
Arash Hospital, Baqdarnia St., East Farjam St., Tehranpars
City
Tehran
Province
Tehran
Postal code
1653915981
Approval date
2021-11-10, 1400/08/19
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.914

Health conditions studied

1

Description of health condition studied
Endometriosis
ICD-10 code
N80
ICD-10 code description
Endometriosis

Primary outcomes

1

Description
Degree of dysmenorrhea using visual pain ruler
Timepoint
At the beginning of the study and three months after starting treatment
Method of measurement
Using visual pain ruler

2

Description
Degree of dyspareunia using visual pain ruler
Timepoint
At the beginning of the study and three months after starting treatment
Method of measurement
Using pain ruler

3

Description
Degree of pelvic pain using pain ruler
Timepoint
At the beginning of the study and three months after starting treatment
Method of measurement
Using pain ruler

4

Description
Size change of Endometriosis lesions by Sonography or Laparascopy
Timepoint
At the beginning of the study and three months after starting treatment
Method of measurement
By performing ultrasound or diagnostic laparoscopy

5

Description
Number Change of endometriosis lesions by performing ultrasound
Timepoint
At the beginning of the study and three months after starting treatment
Method of measurement
By performing ultrasound or diagnostic laparoscopy

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Women aged 18 to 45 years with pain associated with endometriosis, who receive Achillea cretica syrup from Noush Daroo Toosan Salamat Company in addition to one dinogest tablet 2 grams per day for three months.
Category
Treatment - Drugs

2

Description
Control group: Women aged 18 to 45 years with pain associated with endometriosis, who receive placebo Achillea cretica syrup from Noush Daroo Toosan Salamat Company in addition to one dinogest tablet 2 grams per day for three month
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Arash Hospital
Full name of responsible person
Reyhaneh Hosseini
Street address
Arash Hospital, Baqdarnia St., East Farjam St., Tehranpars
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Email
hosp_arash@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Fotohi
Street address
Arash Hospital, Baqdarnia St., East Farjam St., Tehranpars
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Email
hosp_arash@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Soheila Sadat Moosavifar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Arash hospital_Baqdarnia st_East Farjam st_Tehranpars st
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 912 633 5414
Fax
Email
soheilamoosavifar@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soheila Sadat Moosavifar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Arash hospital_Baqdarnia st_East Farjam st_Tehranpars st
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 912 633 5414
Fax
Email
soheilamoosavifar@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soheila Sadat Moosavifar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Arash hospital_Baqdarnia st_East Farjam st_Tehranpars st
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 912 633 5414
Fax
Email
soheilamoosavifar@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
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