Polycystic Ovary SyndromeNCT05029492
Effect of Visceral Manipulation on PCOS
A study testing Low-calorie diet and Visceral manipulation with diet in people with Polycystic Ovary Syndrome, run by Mahitab Mohammed Yosri Ibrahim.
Trial summary
The study was conducted to determine the effect of visceral manipulation on menstrual irregularities and hormonal profile in women with polycystic ovarian syndrome. Thirty women were randomly and equally assigned into the group (A) (Control group), who received a low caloric diet (1200 Kcal/day) only for 3 months, and… Read more about this study
- Who is it for?
- Ages 20 to 34 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Low-calorie diet and Visceral manipulation with diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 34 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women having PCOS.
- 25 ≤ BMI ≤ 30 Kg/m2.
- Waist/hip ratio ≤ 0.80.
- Women experiencing irregular menstrual cycles.
Who cannot join
- Having cardiovascular diseases, diabetes mellitus, and/ or hypertension
- Having malignancy.
- Presence of reproductive disorders unrelated to PCOS.
- Presence of adrenal gland abnormalities.
About this study
Official title: Effect of Visceral Manipulation on Polycystic Ovarian Syndrome
The study was conducted to determine the effect of visceral manipulation on menstrual irregularities and hormonal profile in women with polycystic ovarian syndrome. Thirty women were randomly and equally assigned into the group (A) (Control group), who received a low caloric diet (1200 Kcal/day) only for 3 months, and the group (B) (Study group), who received visceral manipulation to the pelvic organs and the related structures in addition to the same low-calorie diet as the group (A). Evaluations pre and post-study were done for body weight, BMI, female reproductive hormones, and menstruation-related problems.
Read the detailed description
The current study was conducted to determine the effect of visceral manipulation on menstrual irregularities and hormonal profile in women with polycystic ovarian syndrome (PCOS). Thirty women having PCOS were chosen from the outpatient clinic of the faculty of physical therapy, Cairo University. Patients were randomly assigned into two groups equal in number. Group (A) (Control group), 15 PCOS women received a low caloric diet (1200 Kcal/day) for 3 months, while group (B) (Study group), 15 PCOS women received visceral manipulation to the pelvic organs and the related structures (8 sessions, once per week in the first month then once every other week for two months) in addition to the same low-calorie diet as the group (A). Evaluations pre and post-study for body weight, body mass index, female reproductive hormones [luteinizinghormone (LH), follicle-stimulating hormone (FSH) and LH/FSH ratio] and menstruation-related problems were done by weight- height scale, blood analysis, and menstruation-specific domain of polycystic ovary syndrome health-related quality of life questionnaire (PCOSQ), respectively.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Low-calorie diet, Visceral manipulation with diet
- Keywords
- Polycystic Ovary Syndrome, Menstruation Disturbances, Caloric Restriction, Manipulation Therapy
- Medical subject headings
- Polycystic Ovary Syndrome, Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-calorie dietOther
Also called Control group, Group (A)
Low-calorie diet of 1200 kcal for 3 months, modified every two weeks.
Visceral manipulation with dietOther
Also called Study group, Group (B)
Visceral manipulation to the pelvic organs and their related structures (8 sessions, once per week in the first month then once every other week for two months) added to the same low-calorie diet as the group (A).
| Study group | Role | What they receive |
|---|---|---|
| Diet group | Active comparator | Giving a low caloric diet Receives: Other: Low-calorie diet |
| Visceral manipulation with diet group | Experimental | Giving visceral manipulation added to a low-calorie diet Receives: Other: Visceral manipulation with diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of menstrual complaints' severity
The total score of menstruation- specific domain of polycystic ovarian syndrome questionnaire (PCOSQ) questions, calculated using the following equation: Number of patient/ group x number of questions/ domain. That total score was then used to determine the percentage of change from severity towards the optimal function.
Measured: At baseline and after three months of the intervention.
Secondary outcomes (3)
Change in the levels of reproductive hormones (FSH, LH, LH/FSH ratio)
Human LH and FSH enzyme linked immunosorbent assay (ELISA) kits were used to assess the level of LH and FSH in the blood sample taken from each patient.
Measured: At baseline in the second day of menstruation and after three months of the intervention.
Change in weight
A weight- height scale is used to assess body weight in kilograms.
Measured: At baseline and after three months of the intervention.
Change in Body mass index (BMI)
BMI is measured by the equation weight (Kg)/ height (m^2)
Measured: At baseline and after three months of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study startSep 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Polycystic ovarian women were assigned to either group (A), receiving a low-calorie diet for three months, or group (B), receiving the same diet as group (A) together with visceral manipulation of the pelvic organs and their related structures for the same study period (three months).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahitab Mohammed Yosri Ibrahim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahitab Mohammed Yosri Ibrahim, Cairo University
- Investigators
- Mahitab Yosri, Lecturer of women's health, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029492
- Sponsor's protocol ID
- P.T.REC/012/001044
- Status last verified
- Aug 2021
- First submitted
- 15 Aug 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Visceral Manipulation on Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT05029492
- Acronym / sponsor ID
- P.T.REC/012/001044
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic Ovary Syndrome, Menstruation Disturbances, Caloric Restriction, Manipulation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mahitab Mohammed Yosri IbrahimUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study was conducted to determine the effect of visceral manipulation on menstrual irregularities and hormonal profile in women with polycystic ovarian syndrome. Thirty women were randomly and equally assigned into the group (A) (Control group), who received a low caloric diet (1200 Kcal/day) only for 3 months, and the group (B) (Study group), who received visceral manipulation to the pelvic organs and the related structures in addition to the same low-calorie diet as the group (A). Evaluations pre and post-study were done for body weight, BMI, female reproductive hormones, and menstruation-related problems.
Detailed description
The current study was conducted to determine the effect of visceral manipulation on menstrual irregularities and hormonal profile in women with polycystic ovarian syndrome (PCOS). Thirty women having PCOS were chosen from the outpatient clinic of the faculty of physical therapy, Cairo University. Patients were randomly assigned into two groups equal in number. Group (A) (Control group), 15 PCOS women received a low caloric diet (1200 Kcal/day) for 3 months, while group (B) (Study group), 15 PCOS women received visceral manipulation to the pelvic organs and the related structures (8 sessions, once per week in the first month then once every other week for two months) in addition to the same low-calorie diet as the group (A). Evaluations pre and post-study for body weight, body mass index, female reproductive hormones [luteinizinghormone (LH), follicle-stimulating hormone (FSH) and LH/FSH ratio] and menstruation-related problems were done by weight- height scale, blood analysis, and menstruation-specific domain of polycystic ovary syndrome health-related quality of life questionnaire (PCOSQ), respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Polycystic ovarian women were assigned to either group (A), receiving a low-calorie diet for three months, or group (B), receiving the same diet as group (A) together with visceral manipulation of the pelvic organs and their related structures for the same study period (three months).
| Arm | Type | Receives |
|---|---|---|
| Diet group | Active comparator | Other: Low-calorie dietGiving a low caloric diet |
| Visceral manipulation with diet group | Experimental | Other: Visceral manipulation with dietGiving visceral manipulation added to a low-calorie diet |
Who may qualify
- Ages
- 20 to 34 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women having PCOS.
- 25 ≤ BMI ≤ 30 Kg/m2.
- Waist/hip ratio ≤ 0.80.
- Women experiencing irregular menstrual cycles.
Key exclusion criteria (4 listed)
- Having cardiovascular diseases, diabetes mellitus, and/ or hypertension
- Having malignancy.
- Presence of reproductive disorders unrelated to PCOS.
- Presence of adrenal gland abnormalities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-calorie dietAlso: Control group, Group (A)Low-calorie diet of 1200 kcal for 3 months, modified every two weeks. | Other | Diet group |
| Visceral manipulation with dietAlso: Study group, Group (B)Visceral manipulation to the pelvic organs and their related structures (8 sessions, once per week in the first month then once every other week for two months) added to the same low-calorie diet as the group (A). | Other | Visceral manipulation with diet group |
Primary outcome
Change of menstrual complaints' severity
Time frame: At baseline and after three months of the intervention.
The total score of menstruation- specific domain of polycystic ovarian syndrome questionnaire (PCOSQ) questions, calculated using the following equation: Number of patient/ group x number of questions/ domain. That total score was then used to determine the percentage of change from severity towards the optimal function.
3 secondary outcomes
Change in the levels of reproductive hormones (FSH, LH, LH/FSH ratio)
Time frame: At baseline in the second day of menstruation and after three months of the intervention.
Change in weight
Time frame: At baseline and after three months of the intervention.
Change in Body mass index (BMI)
Time frame: At baseline and after three months of the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahitab Yosri, Lecturer of women's health principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Low-calorie diet and Visceral manipulation with diet in people with Polycystic Ovary Syndrome, run by Mahitab Mohammed Yosri Ibrahim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of menstrual complaints' severity (time frame: At baseline and after three months of the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.