The purpose of this study was to determine the effect of oral capsule of Peganum harmala seed on bone density in menopausal women prone to osteoporosis.This study is a clinical trial of phase 3, single-centered. 100 patients with inclusion Criteria: Postmenopausal women who at least 12 month past after amenorrhea without correlation with pregnancy, breast-feeding or other hormonal disorders ;prone to osreoprosis with T score of less than 2.5 in bone density measurement. Exclusion criteria: Gastrointestinal absorption disorder; Thyroid patients; Kidney and liver diseases are divided into two groups of 50. In the first group: receive peganum harmala capsules 500 mg twice daily with routine treatment and the control group received only routine medications. Three months later, bone densitometry is done . The T score determines response to treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017091910222N12
Registration date:2017-10-22, 1396/07/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-22, 1396/07/30
Registrant information
Name
Zahra Keivani
Name of organization / entity
Shahrekord University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1222 0016
Email address
keivani@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Science
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of oral capsule of Peganum harmala
seed on bone density in menopausal women
prone to osteoporosis
Public title
Evaluation the effect of oral capsule of Peganum harmala
seed on bone density in menopausal women
prone to osteoporosis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Postmenopausal women who at least 12 month past after amenorrhea without correlation with pregnancy, breast-feeding or other hormonal disorders ;prone to osreoprosis with T score of less than 2.5 in bone density measurement.
Exclusion criteria: Gastrointestinal absorption disorder; Thyroid patients; Kidney and liver diseases
Age
From 45 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization not done
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Kashani street, shahrekord university of medical sciences, shahrekord
City
Shahrekord
Postal code
Approval date
2017-03-12, 1395/12/22
Ethics committee reference number
IR.SKUMS.REC.1395.331
Health conditions studied
1
Description of health condition studied
osteoprosis
ICD-10 code
M80-M94
ICD-10 code description
Osteopathies and chondropathies
Primary outcomes
1
Description
T score
Timepoint
3 month after intervention
Method of measurement
Bondensitometry
Secondary outcomes
empty
Intervention groups
1
Description
the first group: receive peganum harmala capsules 500 mg twice daily with routine treatment
Category
Treatment - Drugs
2
Description
the second group receive only routine treatment .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital in Shahrekord
Full name of responsible person
Morteza Dehghan
Street address
Parastar street, Kashani Hospital of Shahrekord University of Medical Sciences, shahrekord
City
shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shahrekord University of Medical Science
Full name of responsible person
Dr. Kamal Solati
Street address
Kashani street, shahrekord university of medical sciences, shahrekord
City
Shahrekord
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 of Shahrekord University of Medical Science
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
Shahrekord University of Medical Sciences
Full name of responsible person
Morteza Dehghan
Position
Ortopedic specialist, Associate Professor
Other areas of specialty/work
Street address
Parastar street, Kashani Hospital of Shahrekord University of Medical Sciences, shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3222 0016
Fax
Email
dehghan_mortaza@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Morteza Dehghan
Position
Ortopedic specialist, Associate Professor
Other areas of specialty/work
Street address
Parastar street, Kashani Hospital of Shahrekord University of Medical Sciences, shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3222 0016
Fax
Email
dehghan_mortaza@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical
Full name of responsible person
Morteza Dehghan
Position
Ortopedic specialist, Associate Professor
Other areas of specialty/work
Street address
Parastar street, Kashani Hospital of Shahrekord University of Medical Sciences, shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3222 0016
Fax
Email
dehghan_mortaza@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)