Post-menopausal WomenNCT06702358
Potential Therapeutic Implications of Laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal Women
A study testing Potential Therapeutic Implications of laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal Women in people with Post-menopausal Women and Visceral Fat, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Potential Therapeutic Implications of laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal Women Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-menopausal Women, Visceral Fat
- What is being tested?
- Potential Therapeutic Implications of laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal Women
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 1 Oct 2024
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Post-menopausal women
- Woman with visceral obesity
- with age ranges from 50-65years
- Body mass index (BMI) more than 30 kg/m2
- WHR more than 0.8
Who cannot join
- Endometrial cancer
- Insulin resistance
- Or metabolic disorders
- Diabetes
- Hypertensive •NOT receiving any medication of obesity
Trial locations and contacts
1 site in 1 country.
About this study
Potential Therapeutic Implications of laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal Women
Read the detailed description
All the patients fitted the inclusion criteria, will be given explanation of the treatment protocol in their understandable language.
Treatment procedures. Group (A): will receive laser acupuncture in addition to traditional treatment (low calorie-diet and physical activity) Group (B): will receive traditional treatment only
Laser acupuncture technique:
Application of laser acupuncture on 10 acupuncture procedure for each woman which will be detected by therapist according to Acupuncture points Will stimulate St 25 (Tianshu), St 36 (Zusanli), Liv 3 (Taichong); P 6 (Neiguan), H 7 (Shenmen) for the psychical aspect of the therapy and Auriculothera- py: 55 (Shenmen) and 87 (Stomach) Each point stimulating will be Stimulation time, 30 s/point two sessions per week for 8 weeks.
- Conditions
- Post-menopausal Women, Visceral Fat
- Being tested
- Potential Therapeutic Implications of laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal Women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potential Therapeutic Implications of laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal WomenOther
Application of laser acupuncture ( E M E ) on 10 acupuncture procedure for each woman which will be detected by therapist according to Acupuncture points Will stimulate St 25 (Tianshu), St 36 (Zusanli), Liv 3 (Taichong); P 6 (Neiguan), H 7 (Shenmen) for the psychical aspect of the therapy and Auriculothera- py: 55 (Shenmen) and 87 (Stomach) Each point stimulating will be Stimulation time, 30 s/point
| Study group | Role | What they receive |
|---|---|---|
| Infrared laser diode | Other | Laser pointer instruments Product Details Infrared laser diode made in Italy, it must be perpendicular with direct contact to each point.
Each point will stimulate bilaterally by a laser beam of the following parameters wave length 904 nm; strength, 24 mW; energy, 0.1 J; stimulation time, 30 s/point Receives: Other: Potential Therapeutic Implications of laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal Women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Potential Therapeutic Implications of laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal Women
measured in both group before and after treatment. To get in touch with the hunger and satiety cues,BMI ,WHR and serum insulin level.
Measured: for 8 weeks
Body Mass Index (BMI)
The weight in kg
Measured: for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start1 Jul 2024
- Primary completion1 Sep 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-menopausal WomenStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Laser pointer instruments Product Details Infrared laser diode made in Italy, it must be perpendicular with direct contact to each point. Each point will stimulate bilaterally by a laser beam of the following parameters wave length 904 nm; strength, 24 mW; energy, 0.1 J; stimulation time, 30 s/point; and two sessions per week for 8 weeks.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nawal Reda Rashad Mohamed, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702358
- Sponsor's protocol ID
- KFSIRB200-92
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 22 Nov 2024
- 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 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Therapeutic Implications of Laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal Women
- ClinicalTrials.gov ID
- NCT06702358
- Acronym / sponsor ID
- KFSIRB200-92
- Conditions
- Post-menopausal Women, Visceral Fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 22 Nov 2024 (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.
Potential Therapeutic Implications of laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal Women
Detailed description
All the patients fitted the inclusion criteria, will be given explanation of the treatment protocol in their understandable language.
Treatment procedures. Group (A): will receive laser acupuncture in addition to traditional treatment (low calorie-diet and physical activity) Group (B): will receive traditional treatment only
Laser acupuncture technique:
Application of laser acupuncture on 10 acupuncture procedure for each woman which will be detected by therapist according to Acupuncture points Will stimulate St 25 (Tianshu), St 36 (Zusanli), Liv 3 (Taichong); P 6 (Neiguan), H 7 (Shenmen) for the psychical aspect of the therapy and Auriculothera- py: 55 (Shenmen) and 87 (Stomach) Each point stimulating will be Stimulation time, 30 s/point two sessions per week for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Laser pointer instruments Product Details Infrared laser diode made in Italy, it must be perpendicular with direct contact to each point. Each point will stimulate bilaterally by a laser beam of the following parameters wave length 904 nm; strength, 24 mW; energy, 0.1 J; stimulation time, 30 s/point; and two sessions per week for 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Infrared laser diode | Other | Other: Potential Therapeutic Implications of laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal WomenLaser pointer instruments Product Details Infrared laser diode made in Italy, it must be perpendicular with direct contact to each point. Each point will stimulate bilaterally by a laser beam of the following parameters wave length 904 nm; strength, 24 mW; energy, 0.1 J; stimulation time, 30 s/point |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Post-menopausal women
- Woman with visceral obesity
- with age ranges from 50-65years
- Body mass index (BMI) more than 30 kg/m2
- WHR more than 0.8
Key exclusion criteria (5 listed)
- Endometrial cancer
- Diabetes
- Hypertensive •NOT receiving any medication of obesity
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 |
|---|---|---|
| Potential Therapeutic Implications of laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal WomenApplication of laser acupuncture ( E M E ) on 10 acupuncture procedure for each woman which will be detected by therapist according to Acupuncture points Will stimulate St 25 (Tianshu), St 36 (Zusanli), Liv 3 (Taichong); P 6 (Neiguan), H 7 (Shenmen) for the psychical aspect of the therapy and Auriculothera- py: 55 (Shenmen) and 87 (Stomach) Each point stimulating will be Stimulation time, 30 s/point | Other | Infrared laser diode |
Primary outcome
Potential Therapeutic Implications of laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal Women
Time frame: for 8 weeks
measured in both group before and after treatment. To get in touch with the hunger and satiety cues,BMI ,WHR and serum insulin level.
Body Mass Index (BMI)
Time frame: for 8 weeks
The weight in kg
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 22 Nov 2024.
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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 Potential Therapeutic Implications of laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal Women in people with Post-menopausal Women and Visceral Fat, run by Kafrelsheikh 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 5 inclusion and 5 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 22 Nov 2024. 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?
Potential Therapeutic Implications of laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal Women (time frame: for 8 weeks). The study lists 2 primary outcomes in all. 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 22 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.