Fatty LiverNCT05623930
Liver Enzymes and Metabolic Risk Factors Response to Laser Acupuncture Versus Cupping Therapy in Fatty Liver
A study testing laser acupuncture and wet cupping in people with Fatty Liver, run by Cairo University at 1 site in Egypt.
Trial summary
fatty liver disease is characterized by low antioxidants, disturbed lipid metabolism, cardioautonomic functions, and elevated blood measures (glucose, inflammatory markers, liver enzymes) 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 acupuncture and wet cupping
- 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
- 12 Oct 2022to 1 Apr 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 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- fatty liver obese patients
Who cannot join
- thoracic diseases heart diseases kidney diseases
Trial locations and contacts
1 site in 1 country.
ahmed Elfahl, Lecturer contact
Egypt1 site, 1 recruiting
- Recruiting
Cairo Unoversity
Giza
Ali Ismail, lecturer, 01005154209, allooka2012@gmail.com
About this study
Official title: Hepatic Enzymes and Metabolic-Risk Factors Responses to Laser Acupuncture Versus Cupping Therapy in Fatty Liver
fatty liver disease is characterized by low antioxidants, disturbed lipid metabolism, cardioautonomic functions, and elevated blood measures (glucose, inflammatory markers, liver enzymes)
Read the detailed description
In fatty liver patients,applied cupping (with scarification) will be compared, regarding its effect on antioxidant, lipid metabolism, cardioautonomic functions, and blood measures (glucose, inflammatory markers, liver enzymes), to application of laser on acupoints
- Conditions
- Fatty Liver
- Being tested
- laser acupuncture, wet cupping
- 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 acupunctureDevice
In fatty liver diseased patients which their number will be 30 patients, a 3-session/week application of 2-minute laser (for 3 months) on acupoint number 25,40,36 of stomach meridian, acupoints number 3 and 14 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
wet cuppingOther
in this fatty liver diseased patients which their number will be 30, cupping (with scarification) or wet cupping will be applied at the first day and the day number 14 in the month for three successive months. cupping (with scarification) or wet cupping will be applied on urinary bladder acupoint 17 (on the both sides) and governosal vessels acupoints 12,13,and 14.
| Study group | Role | What they receive |
|---|---|---|
| laser on acupuncture points | Active comparator | In fatty liver diseased patients which their number will be 30 patients, a 3-session/week application of 2-minute laser (for 3 months) on acupoint number 25,40,36 of stomach meridian, acupoints number 3 and 14 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 acupuncture |
| cupping (with scarification) | Active comparator | in this fatty liver diseased patients which their number will be 30, cupping (with scarification) or wet cupping will be applied at the first day and the day number 14 in the month for three successive months. cupping (with scarification) or wet cupping will be applied on urinary bladder acupoint 17 (on the both sides) and governosal vessels acupoints 12,13,and 14. Receives: Other: wet cupping |
What is being measured
The primary outcome is the main question the study is designed to answer.
high density lipoprotein
it is a component of lipid profile
Measured: 12 weeks
Secondary outcomes (11)
cholesterol
it is a component of lipid profile
Measured: 12 weeks
low density lipoprotein
it is a component of lipid profile
Measured: 12 weeks
triglycerides
it is a component of lipid profile
Measured: 12 weeks
blood glucose
fasting level of blood glucose will be measured
Measured: 12 weeks
C reactive protein
high sensitivity levels C reactive protein will be measured
Measured: 12 weeks
Malondialdehyde
it ts oxidative stress marker
Measured: 12 weeks
aspartate transaminase
it is a hepatic enzyme that reports the functions of liver
Measured: 12 weeks
alanine transaminase
it is a hepatic enzyme that reports the functions of liver
Measured: 12 weeks
systolic blood pressure
it will be measured by sphygmomanometer
Measured: 12 weeks
diastolic blood pressure
it will be measured by sphygmomanometer
Measured: 12 weeks
pulse rate
it will be measured manually
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start12 Oct 2022
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2023 (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
- Single blind
- Who is masked
- 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
- NCT05623930
- Sponsor's protocol ID
- P.T.REC/012/004116
- Status last verified
- Nov 2022
- First submitted
- 14 Nov 2022
- Last updated
- 21 Nov 2022
- 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 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Enzymes and Metabolic-Risk Factors Responses to Laser Acupuncture Versus Cupping Therapy in Fatty Liver
- ClinicalTrials.gov ID
- NCT05623930
- Acronym / sponsor ID
- P.T.REC/012/004116
- Conditions
- Fatty Liver
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 21 Nov 2022 (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.
fatty liver disease is characterized by low antioxidants, disturbed lipid metabolism, cardioautonomic functions, and elevated blood measures (glucose, inflammatory markers, liver enzymes)
Detailed description
In fatty liver patients,applied cupping (with scarification) will be compared, regarding its effect on antioxidant, lipid metabolism, cardioautonomic functions, and blood measures (glucose, inflammatory markers, liver enzymes), to application of laser on acupoints
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laser on acupuncture points | Active comparator | Device: laser acupunctureIn fatty liver diseased patients which their number will be 30 patients, a 3-session/week application of 2-minute laser (for 3 months) on acupoint number 25,40,36 of stomach meridian, acupoints number 3 and 14 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) | Active comparator | Other: wet cuppingin this fatty liver diseased patients which their number will be 30, cupping (with scarification) or wet cupping will be applied at the first day and the day number 14 in the month for three successive months. cupping (with scarification) or wet cupping will be applied on urinary bladder acupoint 17 (on the both sides) and governosal vessels acupoints 12,13,and 14. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- fatty liver obese patients
Key exclusion criteria (1 listed)
- thoracic diseases heart diseases kidney 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 acupunctureIn fatty liver diseased patients which their number will be 30 patients, a 3-session/week application of 2-minute laser (for 3 months) on acupoint number 25,40,36 of stomach meridian, acupoints number 3 and 14 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 on acupuncture points |
| wet cuppingin this fatty liver diseased patients which their number will be 30, cupping (with scarification) or wet cupping will be applied at the first day and the day number 14 in the month for three successive months. cupping (with scarification) or wet cupping will be applied on urinary bladder acupoint 17 (on the both sides) and governosal vessels acupoints 12,13,and 14. | Other | cupping (with scarification) |
Primary outcome
high density lipoprotein
Time frame: 12 weeks
it is a component of lipid profile
11 secondary outcomes
cholesterol
Time frame: 12 weeks
low density lipoprotein
Time frame: 12 weeks
triglycerides
Time frame: 12 weeks
blood glucose
Time frame: 12 weeks
C reactive protein
Time frame: 12 weeks
Malondialdehyde
Time frame: 12 weeks
aspartate transaminase
Time frame: 12 weeks
alanine transaminase
Time frame: 12 weeks
systolic blood pressure
Time frame: 12 weeks
diastolic blood pressure
Time frame: 12 weeks
pulse rate
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
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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.
ahmed Elfahl, Lecturer contact
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 acupuncture and wet cupping 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 1 inclusion and 1 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 Nov 2022. 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, ali.mohamed@pt.cu.edu.eg), 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: 12 weeks). 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 Nov 2022.