Acupuncture Efficacy on Lipids in Tinnitus Patients With Obesity

NCT05188365 | Unknown

• 1 other identifier: P.T.REC/012/003525
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

nowadays, published literature affirms strong relation between tinnitus, obesity, and high lipids of blood.

Conditions

Tinnitus, Subjective; Obesity; Lipids

Outcome Measures

Primary Outcomes (1)

• tinnitus handicap inventory

  quality of life measure

  It will be measured after eight weeks of acupuncture

Secondary Outcomes (7)

• cholesterol

  It will be measured after eight weeks of acupuncture

• triglycerides

  It will be measured after eight weeks of acupuncture

• high density lipoprotein

  It will be measured after eight weeks of acupuncture

• low density lipoproetin

  It will be measured after eight weeks of acupuncture

• body mass index

  It will be measured after eight weeks of acupuncture

Study Arms (2)

group A

ACTIVE COMPARATOR

different body acupuncture points will be selected to be manually punctured in addition to 4 acupoints on the skin of abdominal surface (the four points will be electrical stimulated during acupuncture). the session (20 minutes) will repeated thrice weekly. the total duration of the study will be 60 days. The points that will be manually acupunctured all over the body of every patient will be: SJ(3)/SJ(5)/SJ(17)/SJ(18)/SJ(19)/SJ(20)/SJ(21)/SJ(22)/GB(2)/GB(8)/GB(20)/LI(4)/LI(11)/KI(3)/SP(6)/ST(36)/REN(4)/REN(9)/REN(12) The acupuncture points that will be electrically stimulated on the abdomen of every patient will be: bilateral Stomach 25 in addition to gallbladder 28 acupoints.

Other: true acupuncture

Group B

SHAM COMPARATOR

different body acupuncture points will be selected to be manually punctured in addition to 4 acupoints on the skin of abdominal surface (the four points will be electrical stimulated during acupuncture). opposite to group A, in this group, the acupuncture needles will be inserted manually and very adjacent to the real location of group-A acupoints (sham acupuncture). The electrical stimulator will connected to abdominal acupoints (bilateral Stomach 25 in addition to gallbladder 28 acupoints) but it will be turned off during the sessions. the session will repeated thrice weekly. the total duration of the study will be 60 days.

Other: sham acupuncture

Interventions

true acupuncture OTHER

different body acupuncture points will be selected to be manually punctured in addition to 4 acupoints on the skin of abdominal surface (the four points will be electrical stimulated during acupuncture). the session (20 minutes) will repeated thrice weekly. the total duration of the study will be 60 days. The points that will be manually acupunctured all over the body of every patient will be: SJ(3)/SJ(5)/SJ(17)/SJ(18)/SJ(19)/SJ(20)/SJ(21)/SJ(22)/GB(2)/GB(8)/GB(20)/LI(4)/LI(11)/KI(3)/SP(6)/ST(36)/REN(4)/REN(9)/REN(12) The acupuncture points that will be electrically stimulated on the abdomen of every patient will be: bilateral Stomach 25 in addition to gallbladder 28 acupoints.

group A

sham acupuncture OTHER

different body acupuncture points will be selected to be manually punctured in addition to 4 acupoints on the skin of abdominal surface (the four points will be electrical stimulated during acupuncture). opposite to group A, in this group, the acupuncture needles will be inserted manually and very adjacent to the real location of group-A acupoints (sham acupuncture). The electrical stimulator will connected to abdominal acupoints (bilateral Stomach 25 in addition to gallbladder 28 acupoints) but it will be turned off during the sessions. the session will repeated thrice weekly. the total duration of the study will be 60 days

Group B

Eligibility Criteria

• Age: 35 Years - 45 Years
• Gender Eligibility Details: self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• obese patients
• tinnitus complaints (chronic subjective form)

You may not qualify if:

• diabetics
• cardiovascular and neurogenic manifestations

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo Unoversity

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Tinnitus; Obesity

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Study Officials

• Ali Ismail, lecturer

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Ismail, lecturer

CONTACT

02 01005154209; allooka2012@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: December 27, 2021
• First Posted: January 12, 2022
• Study Start: December 6, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: January 28, 2022

Record last verified: 2022-01

Locations

EG (1)