Acupuncture Efficacy on Lipids in Tinnitus Patients With Obesity

January 14, 2022 updated by: Ali Mohamed Ali ismail, Cairo University
nowadays, published literature affirms strong relation between tinnitus, obesity, and high lipids of blood.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • Recruiting
        • Cairo Unoversity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • obese patients
  • tinnitus complaints (chronic subjective form)

Exclusion Criteria:

  • diabetics
  • cardiovascular and neurogenic manifestations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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 Comparator: 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.
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2021

Primary Completion (Anticipated)

April 30, 2022

Study Completion (Anticipated)

April 30, 2022

Study Registration Dates

First Submitted

December 27, 2021

First Submitted That Met QC Criteria

December 27, 2021

First Posted (Actual)

January 12, 2022

Study Record Updates

Last Update Posted (Actual)

January 28, 2022

Last Update Submitted That Met QC Criteria

January 14, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/003525

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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