Fatty Liver , Electroacupuncture, Lipid ProfileNCT04046718

Lipid Profile Response to Electroacupuncture Stimulation in Non Alcoholic Fatty Liver Patients

A study testing electro-acupuncture stimulation in people with Fatty Liver , Electroacupuncture, Lipid Profile, run by Ramy Salama Draz at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 55 years, women only
Conditions the study is for: Fatty Liver , Electroacupuncture, Lipid Profile
What is being tested?: electro-acupuncture stimulation
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: 22 Aug 2019to 29 Dec 2019
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 30 to 55 years
Women only
No healthy volunteers
Adult

Who may be able to join

non alcoholic fatty liver BMI 30-40

Who cannot join

Patients with: (Hepatitis C \& b any form of seizure

Trial locations and contacts

1 site in 1 country.

Egypt1 site

faculty of physical therapy Cairo university
Cairo

Other trials in Egypt

About this study

Official title: Lipid Profile Response to Electroacupuncture

sixty female patients suffering from non-alcoholic fatty liver disease were randomly divided into two equal groups group 1 received electroacupuncture stimulation for 6 weeks at special points of stimulation. group 2 was a control group that received nothing without any change in lifestyle and we assed the response of lipid profile post-treatment protocol in both groupes

Conditions: Fatty Liver , Electroacupuncture, Lipid Profile
Being tested: electro-acupuncture stimulation
Medical subject headings: Fatty Liver

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

electro-acupuncture stimulationDevice
stimulation of acupoints of the liver meridian of lv3 lv14

Study groups in NCT04046718
Study group	Role	What they receive
electroacupuncture	Experimental	the study group received electroacupuncture stimulation at different points Receives: Device: electro-acupuncture stimulation
control group	No intervention	a control group with no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

tri-triglycerides (mg/dl) , total cholesterol (mg/dl) , HDL (mg/dl) , LDL (mg/dl)
lowering of total lipid profile in study group
Measured: 6 weeks

Secondary outcomes (1)

weight (kg) , height (m), BMI (kg/m2)
calculation of body mass index
Measured: 1st week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Aug 201929 Dec 2019

First posted6 Aug 2019
Study start22 Aug 2019
Primary completion25 Nov 2019
Study completion29 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Fatty Liver , Electroacupuncture, Lipid ProfileStudies 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: two group study, one is the study group and the other is a control group
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04046718
Sponsor's protocol ID: P.T.REC/012/001579_1
Status last verified: Aug 2021
First submitted: 3 Aug 2019
Last updated: 6 Aug 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Draz RS, Serry ZMH, Rahmy AF, El Bardesi MS, Taha MM. Electroacupuncture Versus Aerobic Interval Training on Liver Functions in Patients with Nonalcoholic Fatty Liver. J Altern Complement Med. 2020 Jan;26(1):51-57. doi: 10.1089/acm.2019.0182. Epub 2019 Oct 29.
PubMed 31657614

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lipid Profile Response to Electroacupuncture
ClinicalTrials.gov ID: NCT04046718
Acronym / sponsor ID: P.T.REC/012/001579_1
Conditions: Fatty Liver , Electroacupuncture, Lipid Profile
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Ramy Salama DrazUniversity, hospital or other
Study start: 22 Aug 2019 (actual)
Primary completion: 25 Nov 2019 (actual)
Study completion: 29 Dec 2019 (actual)
First posted: 6 Aug 2019 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: two group study, one is the study group and the other is a control group

Arm	Type	Receives
electroacupuncture	Experimental	Device: electro-acupuncture stimulationthe study group received electroacupuncture stimulation at different points
control group	No intervention	–a control group with no intervention

Who may qualify

Ages: 30 to 55 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

non alcoholic fatty liver BMI 30-40

Key exclusion criteria (1 listed)

Patients with: (Hepatitis C \& b any form of seizure

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
electro-acupuncture stimulationstimulation of acupoints of the liver meridian of lv3 lv14	Device	electroacupuncture

Primary outcome

tri-triglycerides (mg/dl) , total cholesterol (mg/dl) , HDL (mg/dl) , LDL (mg/dl)
Time frame: 6 weeks
lowering of total lipid profile in study group

1 secondary outcome

weight (kg) , height (m), BMI (kg/m2)
Time frame: 1st week

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 6 Aug 2021.
Background: PubMed 31657614Draz RS, Serry ZMH, Rahmy AF, El Bardesi MS, Taha MM. Electroacupuncture Versus Aerobic Interval Training on Liver Functions in Patients with Nonalcoholic Fatty Liver. J Altern Complement Med. 2020 Jan;26(1):51-57. doi: 10.1089/acm.2019.0182. Epub 2019 Oct 29.
my orcid account IDLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

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 electro-acupuncture stimulation in people with Fatty Liver , Electroacupuncture, Lipid Profile, run by Ramy Salama Draz 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: finished, as of the sponsor's last update on 6 Aug 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?

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?

tri-triglycerides (mg/dl) , total cholesterol (mg/dl) , HDL (mg/dl) , LDL (mg/dl) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04046718, which also lists 1 linked publication.

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 6 Aug 2021.