Back to resultsLiver Enzymes and Metabolic Risk Factors Response to Laser Acupuncture Versus Cupping Therapy in Fatty Liver
Primary Purpose
Fatty Liver
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
laser acupuncture
wet cupping
Sponsored by
About this trial
This is an interventional treatment trial for Fatty Liver
Eligibility Criteria
Inclusion Criteria: fatty liver obese patients Exclusion Criteria: thoracic diseases heart diseases kidney diseases
Sites / Locations
- Cairo UnoversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
laser on acupuncture points
cupping (with scarification)
Arm Description
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
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.
Outcomes
Primary Outcome Measures
high density lipoprotein
it is a component of lipid profile
Secondary Outcome Measures
cholesterol
it is a component of lipid profile
low density lipoprotein
it is a component of lipid profile
triglycerides
it is a component of lipid profile
blood glucose
fasting level of blood glucose will be measured
C reactive protein
high sensitivity levels C reactive protein will be measured
Malondialdehyde
it ts oxidative stress marker
aspartate transaminase
it is a hepatic enzyme that reports the functions of liver
alanine transaminase
it is a hepatic enzyme that reports the functions of liver
systolic blood pressure
it will be measured by sphygmomanometer
diastolic blood pressure
it will be measured by sphygmomanometer
pulse rate
it will be measured manually
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05623930
Brief Title
Liver Enzymes and Metabolic Risk Factors Response to Laser Acupuncture Versus Cupping Therapy in Fatty Liver
Official Title
Hepatic Enzymes and Metabolic-Risk Factors Responses to Laser Acupuncture Versus Cupping Therapy in Fatty Liver
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatty Liver
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
laser on acupuncture points
Arm Type
Active Comparator
Arm Description
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
Arm Title
cupping (with scarification)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
laser acupuncture
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
wet cupping
Intervention Description
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.
Primary Outcome Measure Information:
Title
high density lipoprotein
Description
it is a component of lipid profile
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
cholesterol
Description
it is a component of lipid profile
Time Frame
12 weeks
Title
low density lipoprotein
Description
it is a component of lipid profile
Time Frame
12 weeks
Title
triglycerides
Description
it is a component of lipid profile
Time Frame
12 weeks
Title
blood glucose
Description
fasting level of blood glucose will be measured
Time Frame
12 weeks
Title
C reactive protein
Description
high sensitivity levels C reactive protein will be measured
Time Frame
12 weeks
Title
Malondialdehyde
Description
it ts oxidative stress marker
Time Frame
12 weeks
Title
aspartate transaminase
Description
it is a hepatic enzyme that reports the functions of liver
Time Frame
12 weeks
Title
alanine transaminase
Description
it is a hepatic enzyme that reports the functions of liver
Time Frame
12 weeks
Title
systolic blood pressure
Description
it will be measured by sphygmomanometer
Time Frame
12 weeks
Title
diastolic blood pressure
Description
it will be measured by sphygmomanometer
Time Frame
12 weeks
Title
pulse rate
Description
it will be measured manually
Time Frame
12 weeks
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
based on self-representation of gender identity.
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
fatty liver obese patients
Exclusion Criteria:
thoracic diseases heart diseases kidney diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
ali.mohamed@pt.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed Elfahl, Lecturer
Email
ahmed.elfahl@buc.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo Unoversity
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Phone
01005154209
Email
allooka2012@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Liver Enzymes and Metabolic Risk Factors Response to Laser Acupuncture Versus Cupping Therapy in Fatty Liver
We'll reach out to this number within 24 hrs