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Fatty Liver Response of Cardio-metabolic Risk Factors to Laser Acupuncture Versus Cupping

Primary Purpose

Fatty Liver

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
laser stimulation for acupoints
cupping with scarification
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatty Liver

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed Fatty liver patients by ultrasonography
  • Class I obese patients

Exclusion Criteria:

  • Cardiovascular and respiratory disorders/diseases.
  • Autoimmune disorders/diseases.
  • Pregnancy
  • Other liver disorders/diseases.

Sites / Locations

  • Faculty of Physical Therapy Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

laser

cupping with scarification

Arm Description

In fatty liver patients (30 patients), a daily application of 4-minute laser (for one month, except Fridays) on acupoint number 25,40,36 of stomach meridian, acupoint number 3 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 fatty liver patients (30 patients),every-two-week applied cupping (with scarification) session within one month on back of upper thorax

Outcomes

Primary Outcome Measures

high-density lipoprotein
serum lipid
low-density lipoprotein
serum lipid
cholesterol
serum lipid
triglyceride
serum lipid

Secondary Outcome Measures

c reactive protein
it will be measured in plasma
blood glucose
fasting gluocse
blood pressure
it will be measure with manual manometer
rate of pulse
it will be measured at radial artery

Full Information

First Posted
July 11, 2021
Last Updated
July 12, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04971434
Brief Title
Fatty Liver Response of Cardio-metabolic Risk Factors to Laser Acupuncture Versus Cupping
Official Title
Non-alcoholic Fatty Liver Response of Cardio-metabolic Risk Factors to Laser Acupuncture Versus Cupping-with-scarification
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 11, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (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
Every-two-week applied cupping (with scarification) session within one month on back of upper thorax is not compared previously regarding its effect on cardio-metabolic risk factors to the daily application of laser on acupoints (for month, except Fridays) in fatty liver patients. This trial will compare the two procedure effects on cardio-metabolic risk factors in fatty liver.
Detailed Description
In fatty liver patients,every-two-week applied cupping (with scarification) session within one month on back of upper thorax for 30 patients will be compared regarding its effect on cardio-metabolic risk factors to the daily application of laser on acupoints (for month, except Fridays) of other 30 patients.

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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
laser
Arm Type
Experimental
Arm Description
In fatty liver patients (30 patients), a daily application of 4-minute laser (for one month, except Fridays) on acupoint number 25,40,36 of stomach meridian, acupoint number 3 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
Experimental
Arm Description
In fatty liver patients (30 patients),every-two-week applied cupping (with scarification) session within one month on back of upper thorax
Intervention Type
Device
Intervention Name(s)
laser stimulation for acupoints
Intervention Description
In fatty liver patients (30 patients), a daily application of 4-minute laser (for one month, except Fridays) on acupoint number 25,40,36 of stomach meridian, acupoint number 3 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)
cupping with scarification
Intervention Description
In fatty liver patients (30 patients),every-two-week applied cupping (with scarification) session within one month on back of upper thorax
Primary Outcome Measure Information:
Title
high-density lipoprotein
Description
serum lipid
Time Frame
It will be measured after 4 weeks of treatment
Title
low-density lipoprotein
Description
serum lipid
Time Frame
It will be measured after 4 weeks of treatment
Title
cholesterol
Description
serum lipid
Time Frame
It will be measured after 4 weeks of treatment
Title
triglyceride
Description
serum lipid
Time Frame
It will be measured after 4 weeks of treatment
Secondary Outcome Measure Information:
Title
c reactive protein
Description
it will be measured in plasma
Time Frame
It will be measured after 4 weeks of treatment
Title
blood glucose
Description
fasting gluocse
Time Frame
It will be measured after 4 weeks of treatment
Title
blood pressure
Description
it will be measure with manual manometer
Time Frame
It will be measured after 4 weeks of treatment
Title
rate of pulse
Description
it will be measured at radial artery
Time Frame
It will be measured after 4 weeks of treatment

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
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: Diagnosed Fatty liver patients by ultrasonography Class I obese patients Exclusion Criteria: Cardiovascular and respiratory disorders/diseases. Autoimmune disorders/diseases. Pregnancy Other liver disorders/diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
allooka2012@gmail.com
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
Faculty of Physical Therapy Cairo University
City
Giza
State/Province
Dokki
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
allooka2012@gmail.com

12. IPD Sharing Statement

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Fatty Liver Response of Cardio-metabolic Risk Factors to Laser Acupuncture Versus Cupping

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