Acupuncture Efficacy on Lipids in Tinnitus Patients With Obesity

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

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

Official Title
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Acupuncture Efficacy on Lipids in Tinnitus Patients With Obesity

Conditions
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Tinnitus, Subjective, Obesity, Lipids

Intervention / Treatment
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* Other: true acupuncture
* Other: sham acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: obese patients tinnitus complaints (chronic subjective form) Exclusion Criteria: diabetics cardiovascular and neurogenic manifestations

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group A<br>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<br>* 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.<br>|
| Sham Comparator: Group B<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tinnitus handicap inventory | quality of life measure | It will be measured after eight weeks of acupuncture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cholesterol | serum lipid | It will be measured after eight weeks of acupuncture | 
| triglycerides | serum lipid | It will be measured after eight weeks of acupuncture | 
| high density lipoprotein | serum lipid | It will be measured after eight weeks of acupuncture | 
| low density lipoproetin | serum lipid | It will be measured after eight weeks of acupuncture | 
| body mass index | anthropometry measure | It will be measured after eight weeks of acupuncture | 
| waist circumference | anthropometry measure | It will be measured after eight weeks of acupuncture | 
| visual analogue scale | as a measure for severity of ear tinnitus | It will be measured after eight weeks of acupuncture |