- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04971434
Fatty Liver Response of Cardio-metabolic Risk Factors to Laser Acupuncture Versus Cupping
July 12, 2021 updated by: Ali Mohamed Ali ismail, Cairo University
Non-alcoholic Fatty Liver Response of Cardio-metabolic Risk Factors to Laser Acupuncture Versus Cupping-with-scarification
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Dokki
-
Giza, Dokki, Egypt
- Recruiting
- Faculty of Physical Therapy Cairo University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 55 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: laser
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), 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
|
|
EXPERIMENTAL: cupping with scarification
In fatty liver patients (30 patients),every-two-week applied cupping (with scarification) session within one month on back of upper thorax
|
In fatty liver patients (30 patients),every-two-week applied cupping (with scarification) session within one month on back of upper thorax
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
high-density lipoprotein
Time Frame: It will be measured after 4 weeks of treatment
|
serum lipid
|
It will be measured after 4 weeks of treatment
|
|
low-density lipoprotein
Time Frame: It will be measured after 4 weeks of treatment
|
serum lipid
|
It will be measured after 4 weeks of treatment
|
|
cholesterol
Time Frame: It will be measured after 4 weeks of treatment
|
serum lipid
|
It will be measured after 4 weeks of treatment
|
|
triglyceride
Time Frame: It will be measured after 4 weeks of treatment
|
serum lipid
|
It will be measured after 4 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
c reactive protein
Time Frame: It will be measured after 4 weeks of treatment
|
it will be measured in plasma
|
It will be measured after 4 weeks of treatment
|
|
blood glucose
Time Frame: It will be measured after 4 weeks of treatment
|
fasting gluocse
|
It will be measured after 4 weeks of treatment
|
|
blood pressure
Time Frame: It will be measured after 4 weeks of treatment
|
it will be measure with manual manometer
|
It will be measured after 4 weeks of treatment
|
|
rate of pulse
Time Frame: It will be measured after 4 weeks of treatment
|
it will be measured at radial artery
|
It will be measured after 4 weeks of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 11, 2021
Primary Completion (ANTICIPATED)
December 1, 2021
Study Completion (ANTICIPATED)
December 1, 2021
Study Registration Dates
First Submitted
July 11, 2021
First Submitted That Met QC Criteria
July 12, 2021
First Posted (ACTUAL)
July 21, 2021
Study Record Updates
Last Update Posted (ACTUAL)
July 21, 2021
Last Update Submitted That Met QC Criteria
July 12, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/003251
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.