Back to resultsLipid Profile Response to Electroacupuncture Stimulation in Non Alcoholic Fatty Liver Patients
Primary Purpose
Fatty Liver , Electroacupuncture, Lipid Profile
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
electro-acupuncture stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Fatty Liver , Electroacupuncture, Lipid Profile
Eligibility Criteria
Inclusion Criteria:
non alcoholic fatty liver BMI 30-40
Exclusion Criteria:
- Patients with: (Hepatitis C & b any form of seizure
Sites / Locations
- faculty of physical therapy Cairo university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
electroacupuncture
control group
Arm Description
the study group received electroacupuncture stimulation at different points
a control group with no intervention
Outcomes
Primary Outcome Measures
tri-triglycerides (mg/dl) , total cholesterol (mg/dl) , HDL (mg/dl) , LDL (mg/dl)
lowering of total lipid profile in study group
Secondary Outcome Measures
weight (kg) , height (m), BMI (kg/m2)
calculation of body mass index
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04046718
Brief Title
Lipid Profile Response to Electroacupuncture Stimulation in Non Alcoholic Fatty Liver Patients
Official Title
Lipid Profile Response to Electroacupuncture
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 22, 2019 (Actual)
Primary Completion Date
November 25, 2019 (Actual)
Study Completion Date
December 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ramy Salama Draz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatty Liver , Electroacupuncture, Lipid Profile
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two group study, one is the study group and the other is a control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
electroacupuncture
Arm Type
Experimental
Arm Description
the study group received electroacupuncture stimulation at different points
Arm Title
control group
Arm Type
No Intervention
Arm Description
a control group with no intervention
Intervention Type
Device
Intervention Name(s)
electro-acupuncture stimulation
Intervention Description
stimulation of acupoints of the liver meridian of lv3 lv14
Primary Outcome Measure Information:
Title
tri-triglycerides (mg/dl) , total cholesterol (mg/dl) , HDL (mg/dl) , LDL (mg/dl)
Description
lowering of total lipid profile in study group
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
weight (kg) , height (m), BMI (kg/m2)
Description
calculation of body mass index
Time Frame
1st week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
non alcoholic fatty liver BMI 30-40
Exclusion Criteria:
Patients with: (Hepatitis C & b any form of seizure
Facility Information:
Facility Name
faculty of physical therapy Cairo university
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31657614
Citation
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.
Results Reference
background
Links:
URL
https://orcid.org/0000-0003-4089-323X
Description
my orcid account ID
Learn more about this trial
Lipid Profile Response to Electroacupuncture Stimulation in Non Alcoholic Fatty Liver Patients
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