Determining the effect of Leech Therapy And Dry Cupping With Contraceptives LD On Improvement Of Menstrual Complaints In Women With Polycystic Ovary Syndrome
Design
Clinical trial with control group, Blinded, Randomised, with 40 Patients
Settings and conduct
The present study will be performed on women aged 18 to 40 who refer to Gonabad and Bojnourd traditional medicine centers. 40 patients, If they have arrival conditions, are randomly divided into two groups.
In one group, Leech therapy and dry cupping will be done.This will be done once a week after the menstrual bleeding until the next menstrual period.The second group consume Low dose (LD) tablets by starting menstruation on daily basis for 21 days.These interventions will be performed in two months, and the duration of menstrual cycle, bleeding volume and menstrual pain will be followed up monthly by their special questionnaire for three months. Also the present study of a one-way is blind and the study for a person who is responsible for statistical analysis will be blind and does not know which questionnaire is related to which intervention
Participants/Inclusion and exclusion criteria
Inclusion criteria:Women 18 to 40 years of age have polycystic ovaries, Body mass index Between 18.5 to 24.9
Exclusion criteria: Individual Intolerance to Leeches or Cupping or LD, Unwillingness to Continue Participate in the Study
Intervention groups
Intervention group: Intervention with leech therapy and Dry cupping will be Performed once a week after the end of menstrual bleeding until the next menstrual period
control group: LD contraceptive pills should be taken daily for 21 days from the beginning of menstruation, and then the pill should be stopped for 7 days and another pack should be started
Interventions will be done for 2 months
Main outcome variables
Duration of the menstrual cycle, Menstrual bleeding volume, Menstrual cramps
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200623047903N1
Registration date:2020-07-25, 1399/05/04
Registration timing:registered_while_recruiting
Last update:2020-07-25, 1399/05/04
Update count:0
Registration date
2020-07-25, 1399/05/04
Registrant information
Name
Ainaz Khodaverdian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3222 3280
Email address
ainazkvn@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-25, 1399/05/04
Expected recruitment end date
2021-03-15, 1399/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect Of Leech therapy and Dry cupping with Contraceptives LD on Improvement of Menstrual Complaints in Women with Polycystic Ovary Syndrome
Public title
Effect of Leech Therapy and Dry cupping on Polycystic Ovary Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The Polycystic Ovaries based on the individual's satatement
Having Written and oral consent to participate in the study
Age range of 18 to 40
Having reading and writing Literacy
Body mass index Between 18.5 to 24.9
Lack of drug use
No having chronic physical disease
They did not Receive any Treatment for Polycystic Ovaries for 6 Months ago
Failing to use hormonal drugs during the study
Do not Take Hormonal Medications During the Study
Patients with Stable Medical Condition
Not Pregnant
No Breastfeeding
People with Oligomenorrhea
Exclusion criteria:
Individual Intolerance to Leeches or Dry Cupping or LD
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
For sampling, first each qualified person is selected to enter the study and Then the samples will be placed in the available method based on 4 blocks and random allocation in each of the two intervention groups (intervention) A or (control) B.
4 blocks will be used for sampling(AABB, ABAB, BBAA, BABA, ABBA,BAAB)
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study each questionnaire will be marked with the letters A (intervention group) and B (control group). People who do statistical work and analysis of data are blind to each participant than the intervention
provided in this way, the person does not know which questionnaire is related to which intervention.After explaining the research to the research units and obtaining informed written consent based on random allocation, they will be placed in two groups of intervention and control
4 blocks will be used for sampling(AABB, ABAB, BBAA, BABA, ABBA,BAAB)
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
No. 79, Ranjbar Ave., West Taleghani
City
Bojnourd
Province
North Khorasan
Postal code
9414844364
Approval date
2020-05-17, 1399/02/28
Ethics committee reference number
1399.033.IR.GMU.REC.
Health conditions studied
1
Description of health condition studied
Polycystic Ovary Syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
The Duration of the Menstrual cycle
Timepoint
Before the Intervention, 1 Month, 2 and 3 Months after the Intervention
Method of measurement
A Researcher-made Questionnaire and Calendar
2
Description
Menstrual Bleeding Volume
Timepoint
Before the Intervention, 1 Month, 2 and 3 Months after the Intervention
Method of measurement
Blood Visual Assessment Questionnaire
3
Description
The Severity of Menstrual Cramps
Timepoint
Before the Intervention, 1 Month, 2 and 3 Months after the Intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Satisfaction with Treatment
Timepoint
After the Intervention
Method of measurement
Questionnaire
2
Description
Complications
Timepoint
After the Intervention
Method of measurement
Check list
Intervention groups
1
Description
Intervention group: In this group, Leech therapy and Dry cupping will be Performed once a week after the end of Menstrual Bleeding until the Start of the next Menstrual Period. At first Place Leeches from the Farthest Point to the Uterus,That is on the Ankle and then on the Waist an Uterus. Dry cupping with Leech Therapy will be Placed around the Navel and in the Back (around the Spine).This will be done for two months and people are followed up for 3 months
Category
Treatment - Other
2
Description
Control group: This group is treated with Low dose (LD) pills with a combination of 0.03 mg of Ethinyl Estradiol and 0.15 mg of Levonorgestrel.It should be taken daily and at a specific time by the Person for 21 days from the Beginning of Menstruation and then the pill should be Stopped for 7 day and another pack should be started again.This will continue for two Consecutive Cycles
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bojnourd and Gonabad Traditional medicine centers
Full name of responsible person
Ainaz Khodaverdian
Street address
No. 79, Ranjbar Ave., West Taleghani
City
Bojnourd
Province
North Khorasan
Postal code
9414844363
Phone
+98 58 3222 3280
Email
ainazkvn@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Shahla Khosravan
Street address
Gonabad University of Medical Sciences., Asian roadside
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5722 0578
Email
khosravan@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Ainaz Khodaverdian
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 79, Ranjbar Ave., West Taleghani
City
Bojnourd
Province
North Khorasan
Postal code
9414844363
Phone
+98 58 3222 3280
Email
ainazkvn@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Roghaieh Rahmany Beilandi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
No. 79, Ranjbar Ave., West Taleghani
City
Bojnourd
Province
North Khorasan
Postal code
9414844363
Phone
+98 58 3222 3280
Email
roghaiehrahmany@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Ainaz Khodaverdian
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 79, Ranjbar Ave., West Taleghani
City
Bojnourd
Province
North Khorasan
Postal code
9414844363
Phone
+98 58 3222 3280
Email
ainazkvn@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available