The general goal: Evaluation of effects of Punica granatum L. (Persian Gulnar) on bleeding in patients with leiomyoma of uterus. Design: Randomized, double-blind, phase II trial. Study population: Patients with heavy menstrual bleeding referred Shahid Beheshti University of Medical Sciences. Target sample size: Based on a pilot study (two groups of 10 people). The main inclusion criteria: 1) Age: 18-50 years. 2) Ultrasound evidence of uterine leiomyoma (submucosal leiomyoma, intramural leiomyoma, subserosal leiomyoma). 3) History of heavy menstrual bleeding based on the patient's complaint. The main exclusion criteria: 1) Indication of uterine surgery (except Caesarean section or cervical conization). 2) Patients receiving progesterone, acetyl salicylic acid anticoagulant. Intervention: Medication (Gulnar syrup) or placebo administration to patient (5 cc three times a day) in menstrual cycle. Intervention Time: Three months (each month 7 days). Study outcomes: Reduction of menstrual bleeding that is evaluated by Pictorial Blood Loss Assessment Chart (PBAC) and improving quality of life that is evaluated by Menorrhagia Questionnaire (MQ).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013120715703N1
Registration date:2014-02-12, 1392/11/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-02-12, 1392/11/23
Registrant information
Name
Hajar Memarzadeh zavareh
Name of organization / entity
School of Traditional Medicine Traditional Medicine and Materia Medica Research Center Shahid Behesh
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
hajarmemarzadeh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid beheshti University of Medical Sciences
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effects of Punica granatum L.(Persian Gulnar) on bleeding in patients with leiomyoma of uterus (in Iranian Traditional Medicine)
Public title
Evaluation of effects of Persian Gulnar on bleeding in patients with leiomyoma of uterus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) Age: 18-50 years 2) Ultrasound evidence of uterine leiomyoma (submucosal leiomyoma, intramural leiomyoma, subserosal leiomyoma). 3) History of abnormal menstrual bleeding based on the patient's complaint. Exclusion Criteria 1) Indication of uterine surgery (except Caesarean section or cervical conization). 2) Patients receiving progesterone, acetyl salicylic acid anticoagulant. 3) Patients with a positive pregnancy test. 4) History of allergy to Persian Gulnar. 5) Known hemoglobinopathies. 6) Known severe coagulation disorder. 7) Patients receiving Anti-fibrinolytic. 8) Hemoglobin below 9.5. 9) Ultrasound evidence of hyperplasia of the endometrium.
Age
From 18 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Gulnar syrup is made from the aqueous extract of Persian Gulnar.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Velenjak St., Shahid Chamran Highway, Shahid Beheshti university of Medical Sciences.
Street address
Velenjak St., Shahid Chamran Highway, Shahid Beheshti university of Medical Sciences.
City
Tehran
Postal code
Approval date
2013-12-04, 1392/09/13
Ethics committee reference number
1392-1-1-163-1173, 143
Health conditions studied
1
Description of health condition studied
Leiomyoma of uterus
ICD-10 code
D25
ICD-10 code description
Leiomyoma of uterus
Primary outcomes
1
Description
Menstrual blood volume
Timepoint
Before the intervention, weeks 5, 9, 13 after intervention
Method of measurement
Pictorial Blood Loss assessment Chart (PBAC)
2
Description
Quality of life that is evaluated by Menorrhagia Questionnaire (MQ).
Timepoint
Before the intervention, weeks 13 after intervention
Method of measurement
Quality of life that is evaluated by Menorrhagia Questionnaire (MQ).
3
Description
The size of leiomyoma
Timepoint
Before the intervention, weeks 13 after intervention
Method of measurement
ultrasound
Secondary outcomes
1
Description
Side effects
Timepoint
weeks 5, 9, 13 after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Medication administration to patient (Persian Gulnar syrup, 5 cc three times a day) in menstrual cycle. Intervention time: Three months (each month 7 days).
Category
Treatment - Drugs
2
Description
Placebo administration to patients in menstrual cycle. ( 5 cc three times a day) Intervention Time: Two months (each month 7 days).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Traditional Medicine Traditional Medicine and Materia Medica Research Center Shahid Behesh
Full name of responsible person
Hajar Memarzadeh zavareh
Street address
No.8 Shams Alley, Opposite St Tavanir, Vali Asr Street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
School of Traditional Medicine Traditional Medicine and Materia Medica Research Center Shahid Behesh
Full name of responsible person
Mojgan Tansaz M.D, Ph.D, Assistant Professor
Street address
No.8 Shams Alley, opposite St Tavanir, Vali Asr Street, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Traditional Medicine Traditional Medicine and Materia Medica Research Center Shahid Behesh
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
School of Traditional Medicine Traditional Medicine and Materia Medica Research Center Shahid Behesh
Full name of responsible person
Hajar Memarzadeh zavareh
Position
ph.D student of Traditional Medicine
Other areas of specialty/work
Street address
No.8 Shams Alley, Opposite Street Tavanir, Vali Asr Street, Tehran