Our aim in this study was to investigate the effect of traditional medicine (Tonic Onsoli syrup and Samgh Capsule) on monthly bleeding in patients with Poliocystic Ovary Syndrome and oligomenorrhea.
Design
Clinical trials with single group, study type: before and after, simple random sampling and sample size: 20 patients were enrolled in the study. Phase II clinical trial
Settings and conduct
Patients with Polycystic Ovary Syndrome referring to the Gynecology Clinic of School of Traditional Medicine, Shahid Beheshti Medical Sciences
How to do the study: before and after
Participants/Inclusion and exclusion criteria
"Inclusion criteria": Women (married and single) with Polycystic Ovary Syndrome with major complaint of Oligomenorrhea; Age of 17-45 years
"Exclusion Criteria": The presence of any systemic disease with Hyperinsulinaemia and Hyperandrogenism; Pregnancy, Abortion or Postpartum within 6 weeks;Taking hormone medications in the last month; Family history of Breast and Ovarian cancer; Patients who are planning to have pregnancy
Intervention groups
People with Poliocystic Ovary Syndrome and oligomenorrhea who receive the product of traditional medicine (Tonic Onsoli syrup and Samgh Capsule )
Main outcome variables
Occurrence of menstruation, BMI, waist circumference, abdominal circumference, Body fat mass
General information
Reason for update
Acronym
PCOS
IRCT registration information
IRCT registration number:IRCT20180217038764N1
Registration date:2019-06-12, 1398/03/22
Registration timing:retrospective
Last update:2019-06-12, 1398/03/22
Update count:0
Registration date
2019-06-12, 1398/03/22
Registrant information
Name
Mojgan Tansaz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3525
Email address
tansaz_mojgan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-12, 1397/02/22
Expected recruitment end date
2018-12-11, 1397/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Tonic Onsoli syrup and Samgh capsule on creat of the Menstrual cycle in women with Polycystic Ovary Syndrome (PCO) in a pilot study.
Public title
Tonic Onsoli in Polycystic Ovary
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women (married and single) suffering from PCOS with the main complaint of Oligomenorrhea
Age of 45-17 years
Patient Satisfaction
Exclusion criteria:
The presence of any systemic disease with Hyperinsulinaemia and Hyperandrogenism
Pregnancy, abortion or postpartum in the last 6 weeks
Breastfeeding in the first 6 months
Use of hormonal medications in a recent month
Patients who are planning to have a pregnancy.
Age
From 17 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
No 30. Shams Ave, Opposite Tavanir, Valiasr Street
City
Tehran
Province
Tehran
Postal code
1516745811
Approval date
2017-01-29, 1395/11/10
Ethics committee reference number
IR.SBMU.RETECH.REC.1395.901
Health conditions studied
1
Description of health condition studied
Polycystic Ovary Syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Women's menstruation
Timepoint
Before starting the study and 1 month after entering the plan and at the end of the study
Method of measurement
Ultrasound and hormonal testing
Secondary outcomes
1
Description
Oligomenorrhea bleeding
Timepoint
Before starting the study and 1 month after entering the plan and at the end of the study
Method of measurement
Ultrasound and hormonal testing
Intervention groups
1
Description
At night, a capsule of 250 mg with warm water is applied, Components of the drug: Bindaj, Isha, Ishq, Gum (Barley) (2 units); Jundabidder (1 unit); Hanzal (2/5 units); Vinegar (to the required amount).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Traditional Medicine Clinic of Shahid Beheshti University
Full name of responsible person
Mojgan Tansaz
Street address
NO.30, Shams Alley, Vali-e Asr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
tansaz_mojgan@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Somayeh Esmaeili
Street address
NO.30, Shams Alley, Vali-e Asr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
sesmaeili@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mojgan Tansaz
Position
Assistant Professor, Faculty of Traditional Medicine, Shahid Beheshti University
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No. 30, Shams Alley, Vali-e Asr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
tansaz_mojgan@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mojgan Tansaz
Position
Assistant Professor, Faculty of Traditional Medicine, Shahid Beheshti University
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
NO.30, Shams Alley, Vali-e Asr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
tansaz_mojgan@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mojgan tansaz
Position
Assistant Professor, Faculty of Traditional Medicine, Shahid Beheshti University
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
No. 30, Shams Alley, Vali-e Asr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
tansaz_mojgan@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The questionnaires used and the information about the main outcome after the 3 months of publication of the results are shared with the applicants.
When the data will become available and for how long
Start the access period 3 months after printing the results
To whom data/document is available
Researchers working in institutions academic and scientific
What processes are involved for a request to access data/document
After 6 months of sampling and 2 months of statistical analysis and 3 months after printing results
It takes about 14 months to complete. Information is provided to the applicant.