NCT04046718

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2019

Completed
16 days until next milestone

Study Start

First participant enrolled

August 22, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2019

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

August 3, 2019

Last Update Submit

August 4, 2021

Conditions

Fatty Liver , Electroacupuncture, Lipid Profile

Outcome Measures

Primary Outcomes (1)

  • tri-triglycerides (mg/dl) , total cholesterol (mg/dl) , HDL (mg/dl) , LDL (mg/dl)

    lowering of total lipid profile in study group

    6 weeks

Secondary Outcomes (1)

  • weight (kg) , height (m), BMI (kg/m2)

    1st week

Study Arms (2)

electroacupuncture

EXPERIMENTAL

the study group received electroacupuncture stimulation at different points

Device: electro-acupuncture stimulation

control group

NO INTERVENTION

a control group with no intervention

Interventions

electro-acupuncture stimulationDEVICE

stimulation of acupoints of the liver meridian of lv3 lv14

electroacupuncture

Eligibility Criteria

Age30 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • non alcoholic fatty liver BMI 30-40

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy Cairo university

Cairo, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 31657614BACKGROUND

Related Links

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two group study, one is the study group and the other is a control group
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 3, 2019

First Posted

August 6, 2019

Study Start

August 22, 2019

Primary Completion

November 25, 2019

Study Completion

December 29, 2019

Last Updated

August 6, 2021

Record last verified: 2021-08

Locations

EG(1)