The effect of oral Mullein capsules (Verbascum Sp) on uterine leiomyomas size and the amount of menstrual bleeding in women with asymptomatic leiomyomas : a triple blind randomised controlled trial.
Aims: Determining the effect of the oral Mullein capsules (Verbascum Sp) on the size of uterine leiomyoma and the amount of menstrual bleeding in women with asymptomatic uterine leiomyomas. Study design: randomized, triple-blind, placebo-controlled (the assessor, participants, and data analyzer will be unaware of the type of intervention given to every participant). Study population: women with asymptomatic uterine leiomyoma that Higham score before intervention is between 50-100. Inclusion criteria: age 18-50 years, women with at least one asymptomatic uterine fibroid larger than 2.5 cm. Exclusion criteria: pregnancy and lactation, desire to become pregnant during the next three months, uterine leiomyoma in size more than 12 cm, the size of the uterine leiomyoma equal or more than 20 weeks of gestation, anemia requiring treatment, history of chronic diseases and concurrent use of other medications or herbal remedies, history of previous surgery such as myomectomy, use of hormonal therapy in the last three months , presence of a copper or hormone IUD, Allergy to treatment. Sample size: 62 persons, 31 as the intervention group and 31 in the control group. Intervention Study: The women in Intervention group will receive 400 mg oral mullein capsules twice a day for two months. Women in the control group, will receive in similar route to intervention group. The intervention time: two months. Study outcome:The main outcome include size of uterine myoma, loss of menstrual bleeding using Higham chart (PBAC). The secondary outcome include size of uterine, blood levels of hemoglobin.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012827311N2
Registration date:2017-02-10, 1395/11/22
Registration timing:prospective
Last update:
Update count:1
Registration date
2017-02-10, 1395/11/22
Registrant information
Name
Behnaz Sadeghzadeh Oskouei
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 0364
Email address
sadeghzadehb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral Mullein capsules (Verbascum Sp) on uterine leiomyomas size and the amount of menstrual bleeding in women with asymptomatic leiomyomas : a triple blind randomised controlled trial.
Public title
The effect of oral Mullein capsules on the treatment of uterine leiomyomas.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Willingness to participate in the study, having a literate and able to answer the questions, women of reproductive age 18-50 years with asymptomatic uterine leiomyomas that confirmed by abdominal ultrasound (at least one leiomyoma largest than 2.5 cm), women with normal menstruation (35-21 days).
Exclusion criteria: Pregnant and lactating women, desire to become pregnant during the next three months, uterine leiomyoma in size more than 12 cm, the size of the uterine leiomyoma equal or more than 20 weeks of gestation, anemia requiring treatment, history of chronic diseases (such as heart disease, thyroid, etc.) and concurrent use of other medications or herbal remedies, history of previous surgery such as myomectomy, use the OCP or other methods of hormone therapy during the last three months, presence of a copper or hormone IUD, known diseases of the genital tract, Allergy to treatment.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz Univercity of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue,
City
Tabriz
Postal code
Approval date
2017-01-23, 1395/11/04
Ethics committee reference number
IR.TBZMED.REC.1395.1131
Health conditions studied
1
Description of health condition studied
Uterine leiomyomas
ICD-10 code
D25.9
ICD-10 code description
Leiomyoma of uterus -Leiomyoma of uterus, unspecified
Primary outcomes
1
Description
Size of Uterine Liomyoma
Timepoint
before intervention and 2 month after intervention
Method of measurement
Sonography study
2
Description
Menstrual bleeding loss
Timepoint
beefore intervention and 4 ,8 weeks after intervention
Method of measurement
Pictorial Blood Loss Assessment Chart (PBAC)
Secondary outcomes
1
Description
haemoglobin
Timepoint
before intervention and 2 months after intervention
Method of measurement
blood exam
2
Description
size of uterine
Timepoint
before intervention and 2 months after intervention
Method of measurement
Sonography study
3
Description
Side events
Timepoint
two months after intervention
Method of measurement
Checklist of side events
4
Description
Satisfaction with treatment received
Timepoint
two months after intervention
Method of measurement
Checklist of Satisfaction with treatment received
Intervention groups
1
Description
The women in Intervention group will receive 400 mg oral mullein capsules twice a day for two months
Category
Treatment - Drugs
2
Description
women in control group will receive 400 mg placebo capsules (containing starch) twice a day for two months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
AlzahraTherapeutic Educational Center
Full name of responsible person
Nafiseh Ghassab Abdollahi, MSc Student of Midwifery
Street address
Baghshmal Intersection, South Army Street, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Nafiseh Ghassab Abdollahi
Position
MSc Student of Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariati street
City
Tabriz
Postal code
5451796499
Phone
+98 41 4422 1874
Fax
Email
nnn.gassabnnn@gmail.com
Web page address
http://nursing.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Behnaz Sadeghzadeh Oskuei
Position
Assistante Professor, PhD Biology of Reproductive Medicine
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 3479 6770
Fax
Email
sadeghzadehb@tbzmed.ac.ir
Web page address
http://nursing.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Nafiseh Ghassab Abdollahi
Position
MSc Student of Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariati street
City
Tabriz
Postal code
Phone
00
Fax
Email
nnn.gassabnnn@gmail.com
Web page address
http://nursing.tbzmed.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)