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comparison between herbal medicine myrrh , sesamum indicum and oral contraceptive pills for treatment of incomplete abortion

Protocol summary

Study aim
comparison between herbal medicine myrrh , sesamum indicum and oral contraceptive pills for treatment of incomplete abortion
Design
This clinical trial study has a control group, including 4 groups, including group A, LD which is a type of OCP pill, group B, Myrrhs capsule, group C, dried sesame extract capsule and the control group receiving capsules with Avicel. Treatment in groups is done in parallel. 160 patients will be randomly divided into 4 groups. The study was conducted in a double-blind manner, and the patients and the examiner of the results will not be aware of the type of drug used.
Settings and conduct
In this study, 160 patients referred to teaching and therapeutic hospitals affiliated to Shiraz University of Medical Sciences were randomly divided into four groups: group A, LD which is a type of OCP pill, group B, Myrrhs capsules, group C, capsules of dried sesame extract and group Control recipients will be divided into capsules with Avicel. In each group, all medicines will be designed in the same way and the patient will take the medicine for 14 days. The doctors and the examiner of the result will not be aware of the type of drug used. After the end of the transvaginal color Doppler ultrasound treatment, the remnants of the placenta after the abortion are examined and measured by a radiologist.
Participants/Inclusion and exclusion criteria
healthy women with a normal blood count ( hemoglobin > 9) , estimated gestational age less than 20 weeks, with intrauterine tissue with an anterior posterior diameter 15-50 mm less than 1month post abortion, BMI ≤ 30
Intervention groups
Group A (n=40), LD capsule combined with Avasil Group B (n=40), Myrrhs capsule 500 mg BID Group C (n=40), capsules of dried sesame extract Group D 40 (n=40) placebo capsules (containing Avacil). In all groups, medicine (capsule) is prescribed for 14 days
Main outcome variables
incomplete abortion

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240109060656N1
Registration date: 2024-02-08, 1402/11/19
Registration timing: registered_while_recruiting

Last update: 2024-02-08, 1402/11/19
Update count: 0
Registration date
2024-02-08, 1402/11/19
Registrant information
Name
Mojtaba Neydavoodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 5410
Email address
neydavodi41@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
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
comparison between herbal medicine myrrh , sesamum indicum and oral contraceptive pills for treatment of incomplete abortion
Public title
herbal medicine myrrh , sesamum indicum and oral contraceptive pill for treatment of incomplete abortion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
healthy women with a normal blood count ( hemoglobin > ۹) estimated gestational age less than ۲۰ weeks with intrauterine tissue with an anterior posterior diameter ۱۵-۵۰ mm less than ۱ month post abortion BMI ≤ ۳۰ no fever no pelvic tenderness no infection in vaginal exam Age between 18 and 35 years
Exclusion criteria:
Age less than 18 and more than 35 years BMI>30 Presence of infection in vaginal examination
Age
From 18 years old to 35 years old
Gender
Female
Phase
1-2
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
Randomization description
This study includes 160 patients in 4 groups. 160 patients were divided into 40 blocks of 4. Each block is numbered and will be used for 4 patients, that is, if block number 2 is selected in the lottery, the first patient will receive treatment A, the second patient will receive treatment B, the third patient will receive treatment C, and the fourth patient will receive treatment D. The fifth patient will be randomly selected from one of the blocks and the type of treatment will be assigned to the fifth to eighth patients according to the block.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study was conducted in a double-blind manner, and the patients and the examiner of the results (our expert radiologist) will not be aware of the type of drug used. Each drug is placed in a box in the package with a corresponding number label so that the patient does not have any information about the type of drug used. The shape and packaging of myrrh and OCP capsules and sesame and placebo are similar. In this study, our nurse colleague in the hospital affiliated to Shiraz University of Medical Sciences will deliver medicine and placebo to the study participants based on the random block table.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand Street, in front of Palestine Street, central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2023-12-24, 1402/10/03
Ethics committee reference number
IR.SUMS.MED.REC.1402.429

Health conditions studied

1

Description of health condition studied
incomplete abortion
ICD-10 code
O03. 4
ICD-10 code description
Spontaneous abortion Incomplete, without complication.

Primary outcomes

1

Description
Remaining remnants of the placenta after abortion
Timepoint
After the end of 14 days of treatment
Method of measurement
Using the findings observed in transvaginal color doppler ultrasound

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In group A, LD, which is a type of OCP tablet that is placed inside the capsule with Avacil and is prepared as a capsule. This capsule is prescribed for 40 patients for 14 days
Category
Treatment - Drugs

2

Description
Intervention group: Group B Myrrhs capsules to 40 patients, 500 mg BID for 14 days
Category
Treatment - Drugs

3

Description
Intervention group: Group C (n=40),Contact capsules with dried sesame extract are given to 40 patients for 14 days (BID).
Category
Treatment - Drugs

4

Description
40 patients will receive a placebo capsule (containing Avacil) for 14 days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Medical educational hospitals affiliated to Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Rowshani
Street address
Zand Street, in front of Palestine Street, central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
f.rowshani@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempour
Street address
Zand Street, in front of Palestine Street, central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
hashempurm@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Rowshani
Position
Obstetrics and Gynecology assistant student
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zand Street, in front of Palestine Street, central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
f.rowshani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Rowshani
Position
Obstetrics and Gynecology assistant student
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zand Street, in front of Palestine Street, central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
f.rowshani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Rowshani
Position
Obstetrics and Gynecology assistant student
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zand Street, in front of Palestine Street, central building of Shiraz University of Medical Sciences
City
shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
f.rowshani@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data related to the study will not be published
When the data will become available and for how long
Data related to the study will not be published
To whom data/document is available
Data related to the study will not be published
Under which criteria data/document could be used
Data related to the study will not be published
From where data/document is obtainable
Data related to the study will not be published
What processes are involved for a request to access data/document
Data related to the study will not be published
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