Back to resultsAcupuncture Efficacy on Lipids in Tinnitus Patients With Obesity
Primary Purpose
Tinnitus, Subjective, Obesity, Lipids
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
true acupuncture
sham acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus, Subjective
Eligibility Criteria
Inclusion Criteria:
- obese patients
- tinnitus complaints (chronic subjective form)
Exclusion Criteria:
- diabetics
- cardiovascular and neurogenic manifestations
Sites / Locations
- Cairo UnoversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
group A
Group B
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
tinnitus handicap inventory
quality of life measure
Secondary Outcome Measures
cholesterol
serum lipid
triglycerides
serum lipid
high density lipoprotein
serum lipid
low density lipoproetin
serum lipid
body mass index
anthropometry measure
waist circumference
anthropometry measure
visual analogue scale
as a measure for severity of ear tinnitus
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05188365
Brief Title
Acupuncture Efficacy on Lipids in Tinnitus Patients With Obesity
Official Title
Acupuncture Efficacy on Lipids in Tinnitus Patients With Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
nowadays, published literature affirms strong relation between tinnitus, obesity, and high lipids of blood.
Detailed Description
For 8 weeks, our study will search effect of acupuncture on tinnitus (chronic subjective type), lipids and weight reduction in obese persons.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Subjective, Obesity, Lipids
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B
Arm Type
Sham Comparator
Arm Description
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
Intervention Name(s)
true acupuncture
Intervention Description
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
Intervention Name(s)
sham acupuncture
Intervention Description
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
Primary Outcome Measure Information:
Title
tinnitus handicap inventory
Description
quality of life measure
Time Frame
It will be measured after eight weeks of acupuncture
Secondary Outcome Measure Information:
Title
cholesterol
Description
serum lipid
Time Frame
It will be measured after eight weeks of acupuncture
Title
triglycerides
Description
serum lipid
Time Frame
It will be measured after eight weeks of acupuncture
Title
high density lipoprotein
Description
serum lipid
Time Frame
It will be measured after eight weeks of acupuncture
Title
low density lipoproetin
Description
serum lipid
Time Frame
It will be measured after eight weeks of acupuncture
Title
body mass index
Description
anthropometry measure
Time Frame
It will be measured after eight weeks of acupuncture
Title
waist circumference
Description
anthropometry measure
Time Frame
It will be measured after eight weeks of acupuncture
Title
visual analogue scale
Description
as a measure for severity of ear tinnitus
Time Frame
It will be measured after eight weeks of acupuncture
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
self-representation of gender identity.
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
obese patients
tinnitus complaints (chronic subjective form)
Exclusion Criteria:
diabetics
cardiovascular and neurogenic manifestations
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
allooka2012@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo Unoversity
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Phone
01005154209
Email
allooka2012@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Acupuncture Efficacy on Lipids in Tinnitus Patients With Obesity
We'll reach out to this number within 24 hrs