Acupuncture Efficacy on Lipids in Tinnitus Patients With Obesity

NCT ID: NCT05188365

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-06

Study Completion Date

2022-04-30

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.

Conditions

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Tinnitus, Subjective Obesity Lipids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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group A

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 Type ACTIVE_COMPARATOR

true acupuncture

Intervention Type 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 B

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 Type SHAM_COMPARATOR

sham acupuncture

Intervention Type 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

Interventions

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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.

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* obese patients
* tinnitus complaints (chronic subjective form)

Exclusion Criteria

* diabetics
* cardiovascular and neurogenic manifestations
Minimum Eligible Age

35 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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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

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Ali Ismail, lecturer

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Cairo Unoversity

Giza, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ali Ismail, lecturer

Role: CONTACT

02 01005154209

Facility Contacts

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Ali Ismail, lecturer

Role: primary

01005154209

Other Identifiers

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P.T.REC/012/003525

Identifier Type: -

Identifier Source: org_study_id

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