Comparison of the efficacy of wet cupping and blood donation on decrease of menstruation period and insulin resistance in polycystic ovarian syndrome (PCOS)
The aim of this study is comparison the effect of calves wet-cupping with blood donation on decrease of menstruation period and insulin resistance with Pcos. This study is randomized clinical trial and is single central trial. Study group is the women with Pcos according to National Institute of Health criteria. Sample size is 60 members that will divided in two groups with 30 participants. Calves wet-cupping or 20cc cephalic bleeding randomly will done under sterile condition at 26th day of LMP for them. After one month from intervention; time of menstruation is evaluated. Also insulin resistance and quality of life is evaluated before and two weeks after intervention. The participants in this study are 20-40 years old satisfied women with 60 days menstruation cycle and clinical hyper androgens that not be pregnant or lactating; don't have primary ovarian insufficient, thyroid dysfunction, diabetes mellitus, anemia, coagulation diseases, hyper prolactinemia and not users of hormonal or herbal drugs that effect on menstruation. The intervention is calves wet-cupping in control group and 20cc bleeding in witness group. The main outcome is decrease of menstruation period and vaginal bleeding and FBS, insulin, quality of life changes.
General information
Acronym
Poly Cystic Ovarian Syndrome
IRCT registration information
IRCT registration number:IRCT2016080228664N2
Registration date:2016-08-31, 1395/06/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-31, 1395/06/10
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 Hamedan university of medical sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of wet cupping and blood donation on decrease of menstruation period and insulin resistance in polycystic ovarian syndrome (PCOS)
Public title
The effect of wet cupping on regulation of vaginal bleeding in Pcos
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
"20-40 years old women with minimum 60 days menstruation retardation (from LMP)" "Hirsutism according to ferriman Gallwey chart" "Not metformin or hormonal drugs users" "Personal satisfaction"
Exit criteria:
"Use of hormonal or herbal drugs that affect menstruation" "Positive BhcG" "Lactation" "Plan to pregnancy about 3 next 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:
60
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
Ethics committee of Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh Ave, Hamedan, Iran
City
Hamedan
Postal code
6517838678
Approval date
2016-06-11, 1395/03/22
Ethics committee reference number
IR.UMSHA.REC.1395.125
Health conditions studied
1
Description of health condition studied
Pcos
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Decrease of waste hairs growth
Timepoint
Before, 2,6 weeks after intervention
Method of measurement
Ask the patient and complete tracking form
2
Description
Decrease of menstruation cycle period
Timepoint
Before,2,6 weeks after intervention
Method of measurement
Ask the patient and complete tracking form
Secondary outcomes
1
Description
Decrease of insulin resistance
Timepoint
Before and 2 weeks after intervention
Method of measurement
Fasting blood suger &insulin assay
2
Description
Quality of life
Timepoint
Before and 4 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 in intervention group. 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. Vein bleeding will done in control group at 26th day from LMP. Intervention will done only once.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endometrium and Endometriosis Research Center
Full name of responsible person
Azam Meyari, Ph.D student of Traditional Medicine
Street address
Endometrium and Endometriosis Research Center, Fatemieh Hospital, Pasdaran Ave, Hamedan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research and thecnology of Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Vice chancellor for research and thecnology of Hamedan University of Medical Sciences, Hamedan University of Medical Sciences, Shahid Fahmideh Ave, Hamedan
City
Hamedan
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 and thecnology of Hamedan 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
Education and development of medical sciences center, Hamedan 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
Education and development of medical sciences center, Hamedan University of Medical Sciences, Shahid Fahmideh Ave, Hamedan
City
Hamedan
Postal code
6517838736
Phone
+98 81 3838 0238
Fax
+98 81 3838 0246
Email
"d_a_meyari@yahoo.com" "ameyari@sbmu.ac.ir"
Web page address
dme.umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Endometrium and endometriosis research center
Full name of responsible person
Dr. Mahnaz Yavangi
Position
Gynecologist, Associate Professor
Other areas of specialty/work
Street address
Endometrium and endometriosis research center, Fatemieh Hospital, Pasdaran Ave, Hamedan
City
Hamedan
Postal code
6517789971
Phone
+98 81 3825 5474
Fax
+98 81 3828 3939
Email
yavangi@umsha.ac.ir
Web page address
eerc.umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Education and development of medical sciences, Hamedan 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
Education and development of medical sciences, Hamedan University of medical sciences, Shahid Fahmideh Ave, Hamedan
City
Hamedan
Postal code
6517838736
Phone
+98 81 3838 0238
Fax
+98 81 3838 0246
Email
Web page address
dme.umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)