Protocol summary

Summary
This study is a randomized clinical trial to compare the effectiveness of combined herbal product based on fennel with medroxyprogesterone tablet on women with oligo/Amenorrhea from the perspective of traditional persian medicine. 40 patients are accepted based on inclusion criteria. Age range in our sample is between 18 to 40 years. Then randomly divided into two groups intervention and control. In the case group is used of fennel combined product and in control group is used pills medroxyprogesterone 5 mg. The herbal product is used twice a day and the duration of the use is two weeks in each period, which begins in the second and third period after one week after menstruation. If the patients do not menstruate after 2 weeks of taking the drug, we will wait for two more weeks again. After four weeks of therapy if the patients still do not menstruate, we will use the drugs for two more weeks . If the patients menstruate at each stage of using the drug, we start it one week after the end of menstruation. But if the patients were not menstruate after four weeks (two-week using of drug and waiting two weeks), we repeat the previous steps. medroxyprogesterone 5 Mg tablets are also used for 10 days(from 16 to 25 monthly cycles in later cycles) and twice a day. The minimum duration of treatment in this study, three months. At baseline for all patients, ultrasound of the ovaries and uterus, CBC, hormonal tests include: TSH, LH, FSH, PRL, Total Testosteron, for patients is requested. At the end of the study, all patients seen and the necessary data were collected through interviews and questionnaires, and all the tests are repeated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015063022987N1
Registration date: 2017-11-19, 1396/08/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-11-19, 1396/08/28
Registrant information
Name
Farnoush Falahat
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3855 2189
Email address
falahatf901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Center of Mashhad University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of traditional medicine product and medroxyprogesterone tablet on oligo/Amenorrhea in women of reproductive age
Public title
The effects of traditional medicine Product on oligomenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with oligo/Amenorrhea; Aged between 18 to 40 years; Negative pregnancy test; Patient satisfaction . Exclusion criteria: Pregnancy or breast-feeding; Abnormal prolactin levels ;Abnormal thyroid function tests ; FSH> 20 IU / L ;History of organic diseases or gynecological neoplasia;History of chronic renal or hepatic diseases; Severe drug allergy or a history of severe reactions toward unusual plants; Use of Ciprofloxacin, dopamine agonists and antagonists, anti androgens and estrogens; History of any type of chemical hormonal products in 1 month ago; Patients who need other interventions and surgery; Patients with a personal decision to exit from the study
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
University Avenue, Building Qureshi
City
Mashhad
Postal code
Approval date
2015-05-14, 1394/02/24
Ethics committee reference number
IR.MUMS.REC.1394.67

Health conditions studied

1

Description of health condition studied
Oligomenorrhea
ICD-10 code
N91.4
ICD-10 code description
Secondary oligomenorrhoea

Primary outcomes

1

Description
Start of bleeding
Timepoint
Before intervention and 1, 2 & 3 months later
Method of measurement
Question

2

Description
FSH
Timepoint
Beginning & end of study
Method of measurement
ELISA

3

Description
LH
Timepoint
Beginning & end of study
Method of measurement
ELISA

4

Description
total testosterone
Timepoint
Beginning & end of study
Method of measurement
ELISA

Secondary outcomes

1

Description
Side effects
Timepoint
During the study
Method of measurement
Question

Intervention groups

1

Description
Medroxyprogesterone tablets 5 mg, twice a day, for 10 days and in subsequent cycles from 16 to 25 menstruation in the same way
Category
Treatment - Drugs

2

Description
Combined herbal tea based on fennel, 2 times a day, each time a t-bag, for 3 menstrual periods. Duration of use is two weeks in each course that begins a week after purity in period 2 and 3.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Special clinic for Persian Traditional Medicine, Imam Reza (AS) Hospital
Full name of responsible person
Farnoush Falahat
Street address
Special clinic for Persian Traditional Medicine, Imam Reza Sq, Ibn Sina St., Mashhad.
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Cancellor for Research,Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Cancellor for Research,Mashhad University of Medical Sciences, Daneshgah Ave., Golestan Crossroads
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Cancellor for Research,Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Farnoush Falahat
Position
PhD student of Persian and Complementary Medicine
Other areas of specialty/work
Street address
Faculty of Persian and Complementary Medicine, university of Pardis, Azadi square
City
Mashhad
Postal code
Phone
+98 51 3855 2189
Fax
Email
Falahatf901@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zohre Feyzabadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Persian and Complementary Medicine,University of Pardis, Azadi Square
City
Mashhad
Postal code
Phone
+98 51 3884 8931
Fax
Email
Feyzabadiz@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farnoush Falahat
Position
PhD student of Persian and Complementary Medicine
Other areas of specialty/work
Street address
Faculty of Persian and Complementary Medicine, university of Pardis, Azadi Square
City
Mashhad
Postal code
Phone
+98 51 3855 2189
Fax
Email
Falahatf901@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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