Comparison of Traditional Medicine product and metformin and Traditional Medicine product with metformin on menstrual bleeding events in patients with polycystic ovary syndrome complaint oligomenorrhea
The general goal: Comparison of product derived from Traditional Medicine with metformin in oligomenorrhea in patients with polycystic ovarian syndrome. Design: three-group clinical trial. Study population: Women with polycystic ovary syndrome their complaint is oligomenorrhea. Inclusion and exclusion criteria: Age 40-18 years with PCOS confirmed by gynecologist their complaint is oligomenorrhea and no other systemic disease. Patients in the event of pregnancy, the use of steroids and the need for other interventions during treatment or personal taste are excluded. The sample size of 33 patients in each group with respect to the pilot data and a total of 100 patients including the loss of 41 patients in each group and a total of 120 people. Intervention time: 3 months and one month follow-up. The outcome of the study is incidence of bleeding, bleeding volume and bleeding time.
General information
Acronym
PCOS
IRCT registration information
IRCT registration number:IRCT2015042521937N1
Registration date:2015-07-21, 1394/04/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-21, 1394/04/30
Registrant information
Name
Maryam Bahman
Name of organization / entity
School of Traditional Medicine and Materia Medica Research Center, Shahid Beheshti university of M
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
ma.bahman@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-07-01, 1394/04/10
Expected recruitment end date
2016-06-30, 1395/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Traditional Medicine product and metformin and Traditional Medicine product with metformin on menstrual bleeding events in patients with polycystic ovary syndrome complaint oligomenorrhea
Public title
Comparison of the effect of a product from Traditional Medicine with Metformin on oligomenorrhea in polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with PCOS their main complaint is oligomenorrhea. Age 40-18 years, patient satisfaction, the absence of any systemic disease such as hyperinsulinemia, hyperandrogenism, diabetes mellitus, Cushing syndrome, congenital adrenal hyperplasia, hyperprolactinemia and hyperthyroidism, hypertension, lack of pregnancy or within 6 weeks post-partum, lack of breastfeeding, non-hormonal drugs in the last month, no family history of breast and ovarian cancer. Exclusion criteria: Hormone therapy use, side effects, the need for other interventions and surgery, pregnancy occurred during the study, the patient's own request for exclusion.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients were randomly divided into three groups: product of Traditional Medicine, metformin, product of Traditional Medicine with metformin.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Beheshti University of Medical Sciences
Street address
Velenjak St, Shahid Chamran highway, Shahid Beheshti university of Medical Sciences
City
Tehran
Postal code
Approval date
2015-06-14, 1394/03/24
Ethics committee reference number
SBMU.REC.1394.80
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Experience of menstural bleeding
Timepoint
Before intervention and 3, 4 month after intervention
Method of measurement
Question from patient
2
Description
Duration of bleeding
Timepoint
Before the intervention, month 3, 4
Method of measurement
Ask the patient
3
Description
Menstrual blood volume
Timepoint
Before the intervention, month 3,4
Method of measurement
Pictorial Blood Loss Assessment Chart (PBAC)
Secondary outcomes
1
Description
Added at 2016-07-02: interval between menstural periods
Timepoint
Added at 2016-07-02: Before the intervention and 1, 2, and 3 months after the intervention
Method of measurement
Added at 2016-07-02: Asking from patients
Intervention groups
1
Description
Group 3: Traditional product 2 capsules in the morning and 2 nights during the month, except during the period plus metformin 500 mg tablets after every meal during month.
Category
Treatment - Drugs
2
Description
Group 2: Metformin 500 mg tablets after every meal during month
Category
Treatment - Drugs
3
Description
Group 1: Traditional medicine product 2 capsules in the morning and 2 nights during the month, except during the period
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Traditional Medicine and Materia Medica Research Center Shahid Beheshti
Full name of responsible person
Maryam Bahman
Street address
No.8 Shams Alley, opposite Street Tavanir, Vali Asr Street, Tehran
City
Tehran
2
Recruitment center
Name of recruitment center
Private clinic of Mrs Soodabe Bioos
Full name of responsible person
Maryam Bahman
Street address
Charmardan Street, Qom
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
School of Traditional Medicine and Materia Medica Research Center Shahid Beheshti
Full name of responsible person
Mojgan Tansaz M.D. Ph.D, Assistant Professor
Street address
No.8 Shams Alley, Opposite Street 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 and Materia Medica Research Center Shahid Beheshti
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
Maryam Bahman
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
City
Tehran
Postal code
Phone
+98 21 8877 3521
Fax
Email
ma.bahman@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
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
Position
Traditional medicine specialist, Assistant Professor
Other areas of specialty/work
Street address
No.8 Shams Alley, opposite Street Tavanir, Vali Asr Street, Tehran
City
Tehran
Postal code
Phone
+98 21 8877 3521
Fax
Email
Tansaz@sbmu.ac.ir, Tansaz_mojgan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Traditional Medicine Traditional Medicine and Materia Medica Research Center Shahid Behesh
Full name of responsible person
Maryam Bahman
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
City
Tehran
Postal code
Phone
+98 21 8877 3521
Fax
Email
ma.bahman@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)