This study is a clinical trial that assessor and statistical analyzer are blinded. The aim of this study is to compare the efficacy of cupping method versus medroxyprogesterone acetate in reducing menstrual bleeding in patients with disorders of uterine bleeding (DUB). The patients’ populations are 20 to 50 years old females with DUB, screened by gynecologist. They are enrolled after completing informed consent form. The volume of menstrual bleeding is determined by Pictorial Assessment of Blood Loss (PBAC) questionnaire. Estimated sample size, 162 patients, are randomly assigned to two equal groups.The intervention group is treated with cupping in the chest for ten minutes and for three times every half-hour in each day, until the end of the luteal phase of the menstrual cycle. This procedure is repeated for three menstrual cycles. In the control group, patients receive one tablet of 10 mg of medroxyprogesterone acetate, daily, during the luteal phase for three menstrual cycles. Clinical and demographic information questionnaire made by the investigator record baseline measures in the first cycle. Also, PABC and menorrhagia questionnaires complete in the first menstrual cycle as well as one and three months after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052528080N1
Registration date:2016-06-25, 1395/04/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-25, 1395/04/05
Registrant information
Name
AliAsghar Akhlaghi
Name of organization / entity
Clinical Trial Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 3546
Email address
akhlaghi90@gmail.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-11-11, 1394/08/20
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of cupping method and medroxyprogesterone acetate in reducing menstrual bleeding in women with heavy menstrual bleeding
Public title
The effect of cupping method in the treatment of menorrhagia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women with uterine bleeding disorders; Patients referred by a gynecologist with disorders of uterine bleeding; patient with completed informed consent form
Exclusion criteria: women younger than 20 or older than 50 years; history of chest surgery in the last three months; active systemic infection disease; active infected edema on Skin or injury on cupping site; coagulation disorders; use of bleeding-lowering drugs such as Mefenamic acid, etc. during the study period; uterine fibrosis with endometrial thickness; fraction in the chest area ,especially in the ribs 7-12 on cupping site; chemical medicines or herbal and other alternative medicine methods used during the study; pregnant or plan to become pregnant during the study; dependence on drugs in the past 6 months
Age
From 20 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
162
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Tehran University of Medical Sciences
Street address
The Central Organization of Tehran University of Medical Sciences,Corner of Ghods street,Keshavarz Blvd, Tehran
City
Tehran
Postal code
Approval date
2015-08-16, 1394/05/25
Ethics committee reference number
IR.TUMS.REC.1394,596
Health conditions studied
1
Description of health condition studied
DUB
ICD-10 code
N92
ICD-10 code description
Excessive, frequent and irregular menstruation
Primary outcomes
1
Description
patient’s score of bleeding
Timepoint
the first menstrual cycle as well as one and three months after the intervention.
Method of measurement
Pictorial Assessment of Blood Loss questionnaire
Secondary outcomes
1
Description
menorrhagia quality of life questionnaire
Timepoint
1 month
Method of measurement
questionnaire
Intervention groups
1
Description
control group: patients will receive one tablet of 10 mg of medroxyprogesterone acetate, daily, during the luteal phase for three menstrual cycles
Category
Treatment - Drugs
2
Description
The intervention group is treated with cupping in the six symmetrical points on the chest for ten minutes each times and for three times every day , between two course of cupping, 30 minutes rest time exist , this daily procedure repeat until the end of the luteal phase of the menstrual cycle. Also,This procedure continue for three menstrual cycles.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Hospital
Full name of responsible person
Dr.Pirjani
Street address
ASRA Clinic, No. 2, Ghaffari Mahallati Alley, Lower of Telefonkhaneh crossroads, SiMetri Narmak, Narmak, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran university of Medical Sciences
Full name of responsible person
Mohammad Azizkhani
Street address
ASRA Clinic, No. 2, Ghaffari Mahallati Alley, Lower of Telefonkhaneh crossroads, SiMetri Narmak, Narmak, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical SCiences
Full name of responsible person
Mohammad Azizkhani
Position
PhD Candidate
Other areas of specialty/work
Street address
ASRA Clinic, No. 2, Ghaffari Mahallati Alley, Lower of Telefonkhaneh crossroads, SiMetri Narmak, Narmak, Tehran
City
Tehran
Postal code
Phone
+98 21 7790 9020
Fax
Email
Dr_mo_Azizkhani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Unevrsity of Medical Sciences
Full name of responsible person
Dr.Marzieh Vahid Dastjerdi
Position
PhD
Other areas of specialty/work
Street address
Office of hospital head, Arash Hospital, Next to Police Station 126, Baghdarnya St., South Rasheed St., The Second Square of Tehranpars, Tehran
City
Tehran
Postal code
Phone
+98 21 7788 3283
Fax
Email
mdastgerdi@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azizkhani
Position
PhD
Other areas of specialty/work
Street address
ASRA Clinic, No. 2, Ghaffari Mahallati Alley, Lower of Telefonkhaneh crossroads, SiMetri Narmak, Narmak, Tehran
City
Tehran
Postal code
Phone
+98 21 7790 9020
Fax
Email
Dr_mo_azizkhani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)