NCT04971434

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.

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 Jul 2021

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

July 11, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

5 months

First QC Date

July 11, 2021

Last Update Submit

July 12, 2021

Conditions

Fatty Liver

Outcome Measures

Primary Outcomes (4)

  • high-density lipoprotein

    serum lipid

    It will be measured after 4 weeks of treatment

  • low-density lipoprotein

    serum lipid

    It will be measured after 4 weeks of treatment

  • cholesterol

    serum lipid

    It will be measured after 4 weeks of treatment

  • triglyceride

    serum lipid

    It will be measured after 4 weeks of treatment

Secondary Outcomes (4)

  • c reactive protein

    It will be measured after 4 weeks of treatment

  • blood glucose

    It will be measured after 4 weeks of treatment

  • blood pressure

    It will be measured after 4 weeks of treatment

  • rate of pulse

    It will be measured after 4 weeks of treatment

Study Arms (2)

laser

EXPERIMENTAL

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

Device: laser stimulation for acupoints

cupping with scarification

EXPERIMENTAL

In fatty liver patients (30 patients),every-two-week applied cupping (with scarification) session within one month on back of upper thorax

Other: cupping with scarification

Interventions

laser stimulation for acupointsDEVICE

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

laser
cupping with scarificationOTHER

In fatty liver patients (30 patients),every-two-week applied cupping (with scarification) session within one month on back of upper thorax

cupping with scarification

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy Cairo University

Giza, Dokki, Egypt

RECRUITING

MeSH Terms

Conditions

Fatty Liver

Interventions

Acupuncture Points

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

MeridiansAcupuncture TherapyComplementary TherapiesTherapeutics

Study Officials

  • Ali Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Ismail, lecturer

CONTACT

02 01005154209allooka2012@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, 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

July 11, 2021

First Posted

July 21, 2021

Study Start

July 11, 2021

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

July 21, 2021

Record last verified: 2021-07

Locations

EG(1)