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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05188365
Other study ID # P.T.REC/012/003525
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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