Postmenopausal DisorderNCT06015919
Effect of Dash Diet and Acupuncture on Hypertention in Postmenopausal Women
A study testing dash diet and Acupuncture in people with Postmenopausal Disorder, run by Cairo University at 1 site in Egypt.
Trial summary
A study of effect of dash diet and acupuncture on hypertension in postmenopausal women Read more about this study
- Who is it for?
- Ages 50 to 60 years, women only
- Conditions the study is for
- Postmenopausal Disorder
- What is being tested?
- dash diet and Acupuncture
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Dec 2022to 20 Aug 2023
- 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 50 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Their body mass index will be ranged from 25 -29.9 kg/m2
- All patients will be medically stable when attending the study.
- The DASH eating plan of 1800 kcal per day will be used in the study.
Who cannot join
- Auditory and visual problems.
- Chronic renal failure.
- Myocardial infarction or arrythmias with heart failure.
Trial locations and contacts
1 site in 1 country.
About this study
A study of effect of dash diet and acupuncture on hypertension in postmenopausal women
Read the detailed description
45 of post menopausal women divided into three groups A,B,C
- Group (A): It will include 15 post-menopausal women who will be treated by DASH diet and anti-hypertensive drugs.
- Group (B): It will include 15 post-menopausal women who will be treated by acupuncture and anti-hypertensive drugs.
- Group (C): It will include 15 post-menopausal women who will be treated by DASH diet, acupuncture and anti-hypertensive drugs.
- Conditions
- Postmenopausal Disorder
- Being tested
- dash diet, Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dash dietBehavioural
- Group (A): It will include 15 post-menopausal women who will be treated by DASH diet and anti-hypertensive drugs.
- Group (B): It will include 15 post-menopausal women who will be treated by acupuncture and anti-hypertensive drugs.
- Group (C): It will include 15 post-menopausal women who will be treated by DASH diet, acupuncture and anti-hypertensive drugs.
AcupunctureDevice
acupuncture
| Study group | Role | What they receive |
|---|---|---|
| effect of dash diet and acupuncture on hypertention in post menopausal women | Experimental | * Group (A): It will include 15 post-menopausal women who will be treated by DASH diet and anti-hypertensive drugs.
* Group (B): It will include 15 post-menopausal women who will be treated by acupuncture and anti-hypertensive drugs.
* Group (C): It will include 15 post-menopausal women who will be treated by DASH diet, acupuncture and anti-hypertensive drugs. Receives: Behavioral: dash diet; Device: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
it will be measured by sphygmomanometer pre and post treatment
Measured: 3 months
Secondary outcomes (1)
sodium and potassium levels
it will be measured by blood analysis pre and post treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start5 Dec 2022
- Primary completion25 Apr 2023
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal DisorderStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- dash diet and acupuncture on post menopausal hypertention
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- faculty of physical therapy
- Responsible party
- Principal investigator, Alaa Nabil Elsayed Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015919
- Sponsor's protocol ID
- P.T.REC/012/003872
- Status last verified
- Aug 2023
- First submitted
- 10 Feb 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dash Diet and Acupuncture on Hypertention in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06015919
- Acronym / sponsor ID
- P.T.REC/012/003872
- Conditions
- Postmenopausal Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- faculty of physical therapy
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 29 Aug 2023 (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.
A study of effect of dash diet and acupuncture on hypertension in postmenopausal women
Detailed description
45 of post menopausal women divided into three groups A,B,C
- Group (A): It will include 15 post-menopausal women who will be treated by DASH diet and anti-hypertensive drugs.
- Group (B): It will include 15 post-menopausal women who will be treated by acupuncture and anti-hypertensive drugs.
- Group (C): It will include 15 post-menopausal women who will be treated by DASH diet, acupuncture and anti-hypertensive drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- dash diet and acupuncture on post menopausal hypertention
| Arm | Type | Receives |
|---|---|---|
| effect of dash diet and acupuncture on hypertention in post menopausal women | Experimental | Behavioral: dash diet, Device: Acupuncture* Group (A): It will include 15 post-menopausal women who will be treated by DASH diet and anti-hypertensive drugs. * Group (B): It will include 15 post-menopausal women who will be treated by acupuncture and anti-hypertensive drugs. * Group (C): It will include 15 post-menopausal women who will be treated by DASH diet, acupuncture and anti-hypertensive drugs. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Their body mass index will be ranged from 25 -29.9 kg/m2
- All patients will be medically stable when attending the study.
- The DASH eating plan of 1800 kcal per day will be used in the study.
Key exclusion criteria (3 listed)
- Auditory and visual problems.
- Chronic renal failure.
- Myocardial infarction or arrythmias with heart failure.
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 |
|---|---|---|
| dash diet* Group (A): It will include 15 post-menopausal women who will be treated by DASH diet and anti-hypertensive drugs. * Group (B): It will include 15 post-menopausal women who will be treated by acupuncture and anti-hypertensive drugs. * Group (C): It will include 15 post-menopausal women who will be treated by DASH diet, acupuncture and anti-hypertensive drugs. | Behavioural | effect of dash diet and acupuncture on hypertention in post menopausal women |
| Acupunctureacupuncture | Device | effect of dash diet and acupuncture on hypertention in post menopausal women |
Primary outcome
blood pressure
Time frame: 3 months
it will be measured by sphygmomanometer pre and post treatment
1 secondary outcome
sodium and potassium levels
Time frame: 3 months
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 29 Aug 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dash diet and Acupuncture in people with Postmenopausal Disorder, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 3 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 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
blood pressure (time frame: 3 months). 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 29 Aug 2023.