Determining the Effect of wet-cupping on calf muscles Improvement of Amenorrhea and Oligomenorrhea in Patients with Polycystic Ovary Syndrome
Design
The clinical trial with a control group, with parallel groups, without blinding, Block Randomization, phase 3 will be completed on 92 patients. RAS software is used for block randomization.
Settings and conduct
The study is conducted on two control and intervention groups in designated locations (Mahdieh Hospital in Tehran and Shariat Panahi Health College of Shahid Beheshti School of Traditional Medicine). Both groups were given two 500 mg tablets of metformin daily for three months. For the intervention group, once wet-cupping on calf muscles is performed on both legs.
Participants/Inclusion and exclusion criteria
Inclusion: Polycystic ovary women with menstrual disorders aged 18-35 years and have menstrual cycles of at least 60 days in the last year.
Exclusion: Individuals taking metformin or hormonal drugs including herbs and phytoestrogens in the past three months, BHCG positive or lactating women, people with coagulation disorder and anemia
Intervention groups
Two intervention groups will be treated with metformin and one time wet-cupping on calf muscles And the control group will only receive three months of metformin treatment.
Main outcome variables
Frequency of menstrual cycle
General information
Reason for update
Acronym
Pcos
IRCT registration information
IRCT registration number:IRCT20210809052118N1
Registration date:2023-09-13, 1402/06/22
Registration timing:prospective
Last update:2023-09-13, 1402/06/22
Update count:0
Registration date
2023-09-13, 1402/06/22
Registrant information
Name
Leila Goodarzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2234 4877
Email address
leila_goodarzi02ir@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-21, 1402/08/30
Expected recruitment end date
2024-11-20, 1403/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of wet-cupping on calf muscles on improving amenorrhea and oligomenorrhea in patients with polycystic ovary syndrome (PCOs)
Public title
Effect of wet-cupping in treatment oligomenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with polycystic ovarian- age between 18 and 35 with menstrual disorder-who have menstrual cycles of at least 60 days in the last year.
Exclusion criteria:
Patients using metformin or every hormonal drugs, including herbal and phytoestrogens, in the last three months
Positive BHCG titer or lactating women
People with coagulation disorders and anemia
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is done in a non-random, easy way (available sample) and the classification of samples to be assigned to treatment is done in a Block randomization. In other words, people are randomly assigned to the treatment and control groups with equal numbers. The randomization unit is considered individual. RAS statistical software was used as a block randomization tool.
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
The specialized committee of ethics in biomedical research
Street address
Shahid Beheshti University of Medical Sciences, No.2, Aarabi St., Daneshjoo Blvd., Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-04-30, 1402/02/10
Ethics committee reference number
IR.SBMU.RETECH.REC.1402.069
Health conditions studied
1
Description of health condition studied
Polycystic Ovarian Syndrom
ICD-10 code
E28.0
ICD-10 code description
Polycystic Ovarian Syndrom
Primary outcomes
1
Description
Frequency of menstrual cycle
Timepoint
First day and weeks 2, 4, 6, 8, 10, 12
Method of measurement
Asking the patient
Secondary outcomes
1
Description
Length of bleeding period
Timepoint
The first day and weeks 2، 4، 6، 8،10،12
Method of measurement
Ask the patient based on the number of days of bleeding
2
Description
The amount of excess hair(hirsutism)
Timepoint
The first day and weeks 4، 8، 12
Method of measurement
the Freeman Galloway chart
3
Description
Quality of life of patients with polycystic ovary syndrome
Timepoint
The first day and weeks 4، 8، 12
Method of measurement
PCOSQ-50 Questionnaire
Intervention groups
1
Description
Intervention group: Performing cupping of both legs once and on the 26th day of menstrual cycle- At first, the patient will be given the necessary advice about observing the necessary pre-cupping, such as food precautions. The patient sits on a chair next to the bed, the position of the leg cupping that the posterior-lateral part of the leg and the leg is equal to one foot of the hand above the outer ankle, with the cup, connected to the suction cup. The suction takes a few seconds and 30 times. Repeated cupping before cupping causes partial anesthesia and reduces the amount of pain caused by razor. Then، by observing the sterile tips with a bistorial blade No. 11 along the skin lines (almost oblique)، about 10 to 15 subtle superficial incisions are made on the epidermis and dermis surface. The cupping cup is placed again in the area and with three re-suction in it, excess blood is removed. At the end the area is bandaged after sterilization and recommendations are given for care.
Category
Treatment - Other
2
Description
Control group: Two groups receive 500 mg of metformin twice daily for three months.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The main result and some specific goals are published.
Including: the number of menstrual cycles as The main result of the study and the effect of some specific goals such as (increasing the length of the bleeding period - improving the Quality of Life - bleeding in the next month).
Confidentiality of information is maintained.
Personal information is not published.
Only information related to primary and secondary outcomes will be used and shared for analysis.
When the data will become available and for how long
6 months after the publication of the article, the data will be published.
To whom data/document is available
Students and professors of universities of medical sciences and scientific institutions affiliated to universities and the Ministry of Health and Medical Education
Under which criteria data/document could be used
The reasons for using the data it is necessary to obtain the source for the purpose of use
the request and signature of the responsible official of the requesting institution
From where data/document is obtainable
The scientific officer of the project- Correspondence to the declared e-mail
tansaz_mojgan@yahoo.com
What processes are involved for a request to access data/document
Sending a written request with the signature of the official of the requesting institution to the e-mail address of the scientific officer of the project - confirmation of the Requirements to be met (obligation to mention the source) - checking the request and sending the data within a maximum of one month