NCT05632029

Brief Summary

glucose hemosatasis, oxidative stress, abnormalities of blood pressures, and high inflammatory status is high presented in lupus patients.

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
64

participants targeted

Target at P50-P75 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 20, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 20, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

November 20, 2022

Last Update Submit

November 20, 2022

Conditions

Systemic Lupus ErythematosusPreDiabetes

Outcome Measures

Primary Outcomes (1)

  • Malondialdehyde

    oxidative stress indicator

    It will be measured after 4 weeks of laser application

Secondary Outcomes (9)

  • systolic blood pressure

    It will be measured after 4 weeks of laser application

  • diastolic blood pressure

    It will be measured after 4 weeks of laser application

  • blood glucose

    It will be measured after 4 weeks of laser application

  • erythrocyte sedimentation rate (at first hour)

    It will be measured after 4 weeks of laser application

  • erythrocyte sedimentation rate (at second hour)

    It will be measured after 4 weeks of laser application

  • +4 more secondary outcomes

Study Arms (2)

laser (active laser)

ACTIVE COMPARATOR

32 lupus prediabetic women will receive laser acupuncture (active laser) for one month (3 days week) on acupoint number 14 of GV meridian, acupoint number 4 and 11 of large intestine, acupoint number 34 of gall bladder meridian, acupoint number 3 of liver meridian, acupoint number 4, 12, and 9 of conception vessel meridian, acupoint number 40, 36, and 25 of stomach meridian, acupoint number 6 of spleen meridian, and acupoint number 5 of triple energizer meridian, laser will be applied for 1 min on every acupiont)

Device: active laser

laser (sham laser)

SHAM COMPARATOR

32 lupus prediabetic women will receive laser acupuncture (sham . i.e power of the device will be zero) for one month (3 days week) on acupoint number 14 of GV meridian, acupoint number 4 and 11 of large intestine, acupoint number 34 of gall bladder meridian, acupoint number 3 of liver meridian, acupoint number 4, 12, and 9 of conception vessel meridian, acupoint number 40, 36, and 25 of stomach meridian, acupoint number 6 of spleen meridian, and acupoint number 5 of triple energizer meridian, laser will be applied for 1 min on every acupiont)

Device: sham laser

Interventions

active laserDEVICE

32 lupus prediabetic women will receive laser acupuncture (active laser) for one month (3 days week) on acupoint number 14 of GV meridian, acupoint number 4 and 11 of large intestine, acupoint number 34 of gall bladder meridian, acupoint number 3 of liver meridian, acupoint number 4, 12, and 9 of conception vessel meridian, acupoint number 40, 36, and 25 of stomach meridian, acupoint number 6 of spleen meridian, and acupoint number 5 of triple energizer meridian, laser will be applied for 1 min on every acupiont)

laser (active laser)
sham laserDEVICE

32 lupus prediabetic women will receive laser acupuncture (sham laser, i.e power of device will be zero watt) for one month (3 days week) on acupoint number 14 of GV meridian, acupoint number 4 and 11 of large intestine, acupoint number 34 of gall bladder meridian, acupoint number 3 of liver meridian, acupoint number 4, 12, and 9 of conception vessel meridian, acupoint number 40, 36, and 25 of stomach meridian, acupoint number 6 of spleen meridian, and acupoint number 5 of triple energizer meridian, laser will be applied for 1 min on every acupiont)

laser (sham laser)

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbased on self-representation of gender identity.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • prediabetic lupus females (n =64)

You may not qualify if:

  • obesity diabetes heart or respiratory problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo Unoversity

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, SystemicPrediabetic State

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine 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

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 20, 2022

First Posted

November 30, 2022

Study Start

October 20, 2022

Primary Completion

March 30, 2023

Study Completion

March 30, 2023

Last Updated

November 30, 2022

Record last verified: 2022-11

Locations

EG(1)