Cardiovascular Protective Role of Laser Acupuncture in Systemic Lupus

NCT ID: NCT04970199

Last Updated: 2022-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-12

Study Completion Date

2021-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Systemic lupus erythematosus is a chronic and multisystemic autoimmune disorder which predominantly affecting women. The most common cause of death in lupus patients affected by disease for more than 5 years is cardiovascular disease due to presence of some factors as oxidative stress, pro-inflammatory cytokines , dyslipidemia, diabetes, and hypertension.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

laser acupuncture (active or sham) 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) in lupus females

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

System; Lupus Erythematosus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

group 1

thirty lupus women received laser acupuncture (active) 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 was applied for 1 min on every acupiont).

Group Type ACTIVE_COMPARATOR

laser application on acupoints

Intervention Type DEVICE

laser acupuncture

group 2

thirty lupus women received laser acupuncture (sham) for one month (3 days) 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 was be applied for 1 min on every acupiont).

Group Type SHAM_COMPARATOR

laser application on acupoints

Intervention Type DEVICE

laser acupuncture

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

laser application on acupoints

laser acupuncture

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* lupus females
* 60 patients

Exclusion Criteria

* pregnancy
* cardiovascular diseases
* respiratory diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

47 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ali Mohamed Ali ismail

lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ali Ismail, lecturer

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Physical Therapy Cairo University

Giza, Dokki, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P.T.REC/012/003252

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Interleukin23 in Systemic Lupus
NCT06713187 RECRUITING NA
Systemic Lupus Erythematosus
NCT05984316 UNKNOWN NA
Topical Nicotinamide in Treatment of DLE
NCT05362188 COMPLETED EARLY_PHASE1