Objects: The aim of this study is to evaluate the effects of calves wet-cupping on menstruation in amenorrheic and oligomenorrheic women. Design: This study is before and after clinical trial with historical controls and is a single center trial. Study participants are 20 to 40 years old women with amenorrhea or oligomenorrhea that their average menstrual cycle has been 60 days long during past year. Sample size consists of 75 members and calves wet-cupping will be done under sterile condition at 26th day of LMP for all of them. After intervention, time, duration and number of menstruation cycles are evaluated. Also insulin resistance and hormonal changes are evaluated before and three months after intervention. The participants in this study are 20-40 years old women with 60 days menstruation cycle that aren't pregnant or lactating; don't have primary ovarian insufficiency, thyroid dysfunction, diabetes mellitus, anemia, coagulation diseases, hyperprolactinemia and not users of hormonal or herbal drugs that affect menstruation. The intervention is calves wet-cupping and its outcomes are vaginal bleeding and FBS, insulin, testosterone and SHBG changes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062728664N1
Registration date:2016-08-04, 1395/05/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-04, 1395/05/14
Registrant information
Name
Azam Meyari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0572
Email address
ameyari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy of calves wet cupping on vaginal bleeding induce in women with amenorrhea and oligomenorrhea.
Public title
The effect of wet-cupping on amenorrhea and oligomenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20-40 years old women with minimum 60 days menstruation retardation (from LMP); personal satisfaction; Not metformin or hormonal drugs users.
Exclusion criteria:
Use of hormonal or herbal drugs that affect menstruation; Positive BhcG; Lactation; Plannig to be pregnant during the next 3 months; History of thyroid dysfunction; History of anemia; History of coagulation diseases; History of diabetes mellitus; FSH >40; Hyperprolactinemia
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
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
Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Postal code
198396-3113
Approval date
2016-04-10, 1395/01/22
Ethics committee reference number
IR.SBMU.RAM.REC.1395.34
Health conditions studied
1
Description of health condition studied
Pcos
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
2
Description of health condition studied
Ovarian dysfunction
ICD-10 code
E28.9
ICD-10 code description
Ovarian dysfunction, unspecified
Primary outcomes
1
Description
Menstrual blood volume
Timepoint
Before intervention and 1, 2, 4 and 12 weeks after intervention
Method of measurement
Ask the patient and complete tracking form
2
Description
Occurance of Menstrual bleeding
Timepoint
Before intervention and 1, 2, 4 and 12 weeks after intervention
Method of measurement
Ask the patient
3
Description
Duration of menstural bleeding
Timepoint
Before intervention and 1, 2, 4 and 12 weeks after intervention
Method of measurement
Ask the patient and complete tracking form
Secondary outcomes
1
Description
SHBG
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
SHBG serum assay
2
Description
Testosteron
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Serum testosteron assay
3
Description
Insulin resistance
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Fasting blood suger &insulin assay
4
Description
Quality of life
Timepoint
Before intervention and 4&12 weeks after intervention
Method of measurement
Ask the patient and complete tracking form
Intervention groups
1
Description
Calves wet-cupping will done at the 26th day of menstruation cycle. When the patient is in the prone position, calf muscle is suctioned repeatedly to provide a negative pressure. Then under aseptic condition shallow incisions are made by a surgical blade parallel to the body plans and bleeding from incisions will be collected inside the cup through three times suctions. Then skin will be cleaned and covered by dressing. Intervention will done only once.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh hospital
Full name of responsible person
Azam Meyari
Street address
Pasdaran ave, Hamedan, Iran
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shaaid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
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 Shahid Beheshti 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
Traditional school of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azam Meyari
Position
Ph.D student of Traditional Medicine
Other areas of specialty/work
Street address
No.8,Shams Alley, opposite Tavanir, Vali Asr Street, Tehran, Iran
City
Tehran
Postal code
6517789971
Phone
+98 21 8877 3521
Fax
+98 21 8879 5008
Email
d_a_meyari@yahoo.com; ameyari@sbmu.ac.ir
Web page address
traditional.sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Traditional Medicine of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mojgan Tansaz
Position
Traditional medicine specialist, Assistant Professor
Other areas of specialty/work
Street address
No.8 Shams Alley, Opposite Tavanir, Vali Asr Street, Tehran, Iran
City
Tehran
Postal code
65177789971
Phone
+98 21 8877 3521
Fax
+98 21 8879 5008
Email
tansaz_mojgan@sbmu.ac.ir
Web page address
traditional.sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Traditional school of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azam Meyari
Position
Ph.D student of Traditional Medicine
Other areas of specialty/work
Street address
No.8 Shams Alley, Opposite Tavanir, Vali Asr Street, Tehran, Iran
City
Tehran
Postal code
6517789971
Phone
+98 21 8877 3521
Fax
+98 21 8879 5008
Email
d_a_meyari@yahoo.com; ameyari@sbmu.ac.ir
Web page address
traditional.sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)