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

• Sponsor: Ramy Salama Draz (Other)
• Overall Status: Completed
• CT.gov ID: NCT04046718
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.2
• Patients Per Site Per Month: 14.2

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Fatty Liver , Electroacupuncture, Lipid Profile	Device: electro-acupuncture stimulation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: two group study, one is the study group and the other is a control grouptwo group study, one is the study group and the other is a control group
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Lipid Profile Response to Electroacupuncture
• Actual Study Start Date: Aug 22, 2019
• Actual Primary Completion Date: Nov 25, 2019
• Actual Study Completion Date: Dec 29, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: electroacupuncture the study group received electroacupuncture stimulation at different points	Device: electro-acupuncture stimulation; stimulation of acupoints of the liver meridian of lv3 lv14
No Intervention: control group a control group with no intervention

Outcome Measures

Primary Outcome Measures

1. tri-triglycerides (mg/dl) , total cholesterol (mg/dl) , HDL (mg/dl) , LDL (mg/dl) [6 weeks]

   lowering of total lipid profile in study group

Secondary Outcome Measures

1. weight (kg) , height (m), BMI (kg/m2) [1st week]

   calculation of body mass index

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

non alcoholic fatty liver BMI 30-40

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	faculty of physical therapy Cairo university	Cairo		Egypt

Sponsors and Collaborators

• Ramy Salama Draz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• my orcid account ID

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.

• Responsible Party: Ramy Salama Draz, Principal Investigator, Cairo University
• ClinicalTrials.gov Identifier: NCT04046718
• Other Study ID Numbers: P.T.REC/012/001579_1
• First Posted: Aug 6, 2019
• Last Update Posted: Aug 6, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fatty Liver

Study Results

No Results Posted as of Aug 6, 2021