Acupuncture Efficacy on Lipids in Tinnitus Patients With Obesity

Obesity Clinical Trial

Official title:

Acupuncture Efficacy on Lipids in Tinnitus Patients With Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05188365
• Other study ID #: P.T.REC/012/003525
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: January 2022
• Source: Cairo University
• Contact: Ali Ismail, lecturer
• Phone: 02 01005154209
• Email: allooka2012[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

For 8 weeks, our study will search effect of acupuncture on tinnitus (chronic subjective type), lipids and weight reduction in obese persons.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 45 Years

Eligibility

Inclusion Criteria:

• obese patients
• tinnitus complaints (chronic subjective form)

Exclusion Criteria:

• diabetics
• cardiovascular and neurogenic manifestations

Related Conditions & MeSH terms

• Lipids
• Obesity
• Tinnitus
• Tinnitus, Subjective

Intervention

Other:
• true acupuncture
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.
• sham acupuncture
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

Locations

Country	Name	City	State
Egypt	Cairo Unoversity	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tinnitus handicap inventory	quality of life measure	It will be measured after eight weeks of acupuncture
Secondary	cholesterol	serum lipid	It will be measured after eight weeks of acupuncture
Secondary	triglycerides	serum lipid	It will be measured after eight weeks of acupuncture
Secondary	high density lipoprotein	serum lipid	It will be measured after eight weeks of acupuncture
Secondary	low density lipoproetin	serum lipid	It will be measured after eight weeks of acupuncture
Secondary	body mass index	anthropometry measure	It will be measured after eight weeks of acupuncture
Secondary	waist circumference	anthropometry measure	It will be measured after eight weeks of acupuncture
Secondary	visual analogue scale	as a measure for severity of ear tinnitus	It will be measured after eight weeks of acupuncture