Fatty LiverNCT04971434
Fatty Liver Response of Cardio-metabolic Risk Factors to Laser Acupuncture Versus Cupping
A study testing laser stimulation for acupoints and cupping with scarification in people with Fatty Liver, run by Cairo University at 1 site in Egypt.
Trial summary
Every-two-week applied cupping (with scarification) session within one month on back of upper thorax is not compared previously regarding its effect on cardio-metabolic risk factors to the daily application of laser on acupoints (for month, except Fridays) in fatty liver patients. Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Fatty Liver
- What is being tested?
- laser stimulation for acupoints and cupping with scarification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jul 2021to 1 Dec 2021
- 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 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed Fatty liver patients by ultrasonography
- Class I obese patients
Who cannot join
- Cardiovascular and respiratory disorders/diseases.
- Autoimmune disorders/diseases.
- Pregnancy
- Other liver disorders/diseases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy Cairo University
Giza, Dokki
Ali Ismail, lecturer, 02 01005154209, allooka2012@gmail.com
About this study
Official title: Non-alcoholic Fatty Liver Response of Cardio-metabolic Risk Factors to Laser Acupuncture Versus Cupping-with-scarification
Every-two-week applied cupping (with scarification) session within one month on back of upper thorax is not compared previously regarding its effect on cardio-metabolic risk factors to the daily application of laser on acupoints (for month, except Fridays) in fatty liver patients. This trial will compare the two procedure effects on cardio-metabolic risk factors in fatty liver.
Read the detailed description
In fatty liver patients,every-two-week applied cupping (with scarification) session within one month on back of upper thorax for 30 patients will be compared regarding its effect on cardio-metabolic risk factors to the daily application of laser on acupoints (for month, except Fridays) of other 30 patients.
- Conditions
- Fatty Liver
- Being tested
- laser stimulation for acupoints, cupping with scarification
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser stimulation for acupointsDevice
In fatty liver patients (30 patients), a daily application of 4-minute laser (for one month, except Fridays) on acupoint number 25,40,36 of stomach meridian, acupoint number 3 of liver meridian, acupoint number 6 of spleen meridian,acupoint number 9,12,4 of conception vessel meridian, acupoint number 14 of governor vessel meridian, acupoint number 4, 11 of large intestine meridian, acupoint number 34 of gall bladder meridian
cupping with scarificationOther
In fatty liver patients (30 patients),every-two-week applied cupping (with scarification) session within one month on back of upper thorax
| Study group | Role | What they receive |
|---|---|---|
| laser | Experimental | In fatty liver patients (30 patients), a daily application of 4-minute laser (for one month, except Fridays) on acupoint number 25,40,36 of stomach meridian, acupoint number 3 of liver meridian, acupoint number 6 of spleen meridian,acupoint number 9.12,4 of conception vessel meridian, acupoint number 14 of governor vessel meridian, acupoint number 4, 11 of large intestine meridian, acupoint number 34 of gall bladder meridian Receives: Device: laser stimulation for acupoints |
| cupping with scarification | Experimental | In fatty liver patients (30 patients),every-two-week applied cupping (with scarification) session within one month on back of upper thorax Receives: Other: cupping with scarification |
What is being measured
The primary outcome is the main question the study is designed to answer.
high-density lipoprotein
serum lipid
Measured: It will be measured after 4 weeks of treatment
low-density lipoprotein
serum lipid
Measured: It will be measured after 4 weeks of treatment
cholesterol
serum lipid
Measured: It will be measured after 4 weeks of treatment
triglyceride
serum lipid
Measured: It will be measured after 4 weeks of treatment
Secondary outcomes (4)
c reactive protein
it will be measured in plasma
Measured: It will be measured after 4 weeks of treatment
blood glucose
fasting gluocse
Measured: It will be measured after 4 weeks of treatment
blood pressure
it will be measure with manual manometer
Measured: It will be measured after 4 weeks of treatment
rate of pulse
it will be measured at radial artery
Measured: It will be measured after 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start11 Jul 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971434
- Sponsor's protocol ID
- P.T.REC/012/003251
- Status last verified
- Jul 2021
- First submitted
- 11 Jul 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-alcoholic Fatty Liver Response of Cardio-metabolic Risk Factors to Laser Acupuncture Versus Cupping-with-scarification
- ClinicalTrials.gov ID
- NCT04971434
- Acronym / sponsor ID
- P.T.REC/012/003251
- Conditions
- Fatty Liver
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Jul 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 21 Jul 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.
Every-two-week applied cupping (with scarification) session within one month on back of upper thorax is not compared previously regarding its effect on cardio-metabolic risk factors to the daily application of laser on acupoints (for month, except Fridays) in fatty liver patients. This trial will compare the two procedure effects on cardio-metabolic risk factors in fatty liver.
Detailed description
In fatty liver patients,every-two-week applied cupping (with scarification) session within one month on back of upper thorax for 30 patients will be compared regarding its effect on cardio-metabolic risk factors to the daily application of laser on acupoints (for month, except Fridays) of other 30 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laser | Experimental | Device: laser stimulation for acupointsIn fatty liver patients (30 patients), a daily application of 4-minute laser (for one month, except Fridays) on acupoint number 25,40,36 of stomach meridian, acupoint number 3 of liver meridian, acupoint number 6 of spleen meridian,acupoint number 9.12,4 of conception vessel meridian, acupoint number 14 of governor vessel meridian, acupoint number 4, 11 of large intestine meridian, acupoint number 34 of gall bladder meridian |
| cupping with scarification | Experimental | Other: cupping with scarificationIn fatty liver patients (30 patients),every-two-week applied cupping (with scarification) session within one month on back of upper thorax |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosed Fatty liver patients by ultrasonography
- Class I obese patients
Key exclusion criteria (4 listed)
- Cardiovascular and respiratory disorders/diseases.
- Autoimmune disorders/diseases.
- Pregnancy
- Other liver disorders/diseases.
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 |
|---|---|---|
| laser stimulation for acupointsIn fatty liver patients (30 patients), a daily application of 4-minute laser (for one month, except Fridays) on acupoint number 25,40,36 of stomach meridian, acupoint number 3 of liver meridian, acupoint number 6 of spleen meridian,acupoint number 9,12,4 of conception vessel meridian, acupoint number 14 of governor vessel meridian, acupoint number 4, 11 of large intestine meridian, acupoint number 34 of gall bladder meridian | Device | laser |
| cupping with scarificationIn fatty liver patients (30 patients),every-two-week applied cupping (with scarification) session within one month on back of upper thorax | Other | cupping with scarification |
Primary outcome
high-density lipoprotein
Time frame: It will be measured after 4 weeks of treatment
serum lipid
low-density lipoprotein
Time frame: It will be measured after 4 weeks of treatment
serum lipid
cholesterol
Time frame: It will be measured after 4 weeks of treatment
serum lipid
triglyceride
Time frame: It will be measured after 4 weeks of treatment
serum lipid
4 secondary outcomes
c reactive protein
Time frame: It will be measured after 4 weeks of treatment
blood glucose
Time frame: It will be measured after 4 weeks of treatment
blood pressure
Time frame: It will be measured after 4 weeks of treatment
rate of pulse
Time frame: It will be measured after 4 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 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.
Ali Ismail, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser stimulation for acupoints and cupping with scarification in people with Fatty Liver, 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 2 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: status not confirmed, as of the sponsor's last update on 21 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Ismail, lecturer (02 01005154209, allooka2012@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
high-density lipoprotein (time frame: It will be measured after 4 weeks of treatment). The study lists 4 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 21 Jul 2021.