Comparison of the efficacy of capsule of “ Golnar” and Placebo on heavy menstural bleeding in 20- 40 years women: A double- blind randomized clinical trial
The aim of the study: A Comparison on the effects of Golnar and Placebo capsules for the excessive bleeding of menstruation
This study is a double blind randomized clinical trial.Women are 20 to 40 years who bleed more than 7 days or more than 80 cc per cycle, in case of normal gynecological examination, pelvic ultrasound, Pap smear, Prolactin tests, CBC, TSH, PT PTT, will be studied and in case of having heavy bleeding that requires emergency actions or catching Chronic disease and consumption of specific drugs will be excluded from the study. Intervention in each group will be as follows:
1. Consumption of a 500-mg Golnar capsules, 20 minutes after each meal for 7 days since the beginning of the bloodshed in every menstrual cycle for three menstrual cycles.
2. Consumption of a 500-mg Placebo capsules, 20 minutes after each meal for 7 days since the beginning of the bloodshed in every menstrual cycle for three menstrual cycles.
Both groups will be followed for three menstrual cycles.
The primary outcome: the volume of bleeding and bleeding time
The secondary outcomes: changes in Hb, potential drug side effects and quality of life
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017010231722N1
Registration date:2017-04-10, 1396/01/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-10, 1396/01/21
Registrant information
Name
Fatemeh Yousefi
Name of organization / entity
Iran University of Medical Science School of Traditional Medicine
Country
Iran (Islamic Republic of)
Phone
+98 21 5558 0388
Email address
yousefikoopai.f@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran university of medical sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of capsule of “ Golnar” and Placebo on heavy menstural bleeding in 20- 40 years women: A double- blind randomized clinical trial
Public title
Comparison of the efficacy of capsule of “ Golnar” and Placebo on heavy menstural bleeding: A double- blind randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• Informed written consent of patients
• Age 40-20 years
• Has bleeding more than 7 days
• More than 80 cc blood loss (see Hygam chart )
• Endometrial thickness in ultrasound is normal which is equal to or less than 12 mm
• Gynecological examination is normal
• Pap smear results are normal
• Patient has Hb≥11
Exclusion criteria:
• Hemoglobin high level of 16
• Bleeding is so severe that emergency measures needed
• Plan to become pregnant in the next three months
• Catching Systemic or Pelvic inflammatory disease
• Catching chronic diseases such as diabetes, lupus and thyroid problems
• Catching Organic diseases such as cancer of the Uterus or ovaries or other malignancies
• Conjugation of any herbal remedies or certain chemicals that interfere with the study drug or have an impact on menstrual bleeding Such as birth control pills containing estrogen and progesterone or just progestin
• Pregnancy and lactation
• Catching Known hyperprolactinemia
• Catching sub-mucosal or intramural fibroids which are larger than 5 cm
• The patient has no wish to consume these types of drugs
Age
From 20 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
This is the double-blind study: participants and researchers do not know the type of drug or placebo was administered. Participants by Block Randomization will be divided into two groups.Then the drug and placebo accordance with the table are placed randomly in the hands of participants.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commitee of Iran University of Medical Science
Street address
Iran University of Medical Science, Besides Milad Tower, Hemmat Highway, Tehran
City
Tehran
Postal code
Approval date
2016-12-27, 1395/10/07
Ethics committee reference number
IR.IUMS.REC.1395.9221309201
Health conditions studied
1
Description of health condition studied
MENSTURAL BLEEDING
ICD-10 code
N92.0
ICD-10 code description
Excessive and frequent menstruation with regular cycle
Primary outcomes
1
Description
bleeding volume
Timepoint
before and 3 month after intervention
Method of measurement
Higam chart(PBAC Questionaire)
2
Description
duration of bleeding
Timepoint
before and 3 month after intervention
Method of measurement
Questionaire
Secondary outcomes
1
Description
Hemoglobin concentration
Timepoint
Before the intervention, and at the end of each menstrual cycle.