NCT05623930

Brief Summary

fatty liver disease is characterized by low antioxidants, disturbed lipid metabolism, cardioautonomic functions, and elevated blood measures (glucose, inflammatory markers, liver enzymes)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 14, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 21, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

November 14, 2022

Last Update Submit

November 18, 2022

Conditions

Fatty Liver

Outcome Measures

Primary Outcomes (1)

  • high density lipoprotein

    it is a component of lipid profile

    12 weeks

Secondary Outcomes (11)

  • cholesterol

    12 weeks

  • low density lipoprotein

    12 weeks

  • triglycerides

    12 weeks

  • blood glucose

    12 weeks

  • C reactive protein

    12 weeks

  • +6 more secondary outcomes

Study Arms (2)

laser on acupuncture points

ACTIVE COMPARATOR

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

Device: laser acupuncture

cupping (with scarification)

ACTIVE COMPARATOR

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.

Other: wet cupping

Interventions

laser acupunctureDEVICE

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

laser on acupuncture points
wet cuppingOTHER

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.

cupping (with scarification)

Eligibility Criteria

Age35 Years - 55 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsbased on self-representation of gender identity.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • fatty liver obese patients

You may not qualify if:

  • thoracic diseases heart diseases kidney diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo Unoversity

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Ali Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Ismail, lecturer

CONTACT

02 01005154209ali.mohamed@pt.cu.edu.eg

ahmed Elfahl, Lecturer

CONTACT

ahmed.elfahl@buc.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

November 14, 2022

First Posted

November 21, 2022

Study Start

October 12, 2022

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

November 21, 2022

Record last verified: 2022-11

Locations

EG(1)