Tinnitus, SubjectiveNCT05188365
Acupuncture Efficacy on Lipids in Tinnitus Patients With Obesity
A study testing true acupuncture in people with Tinnitus, Subjective and Obesity, run by Cairo University at 1 site in Egypt.
Trial summary
nowadays, published literature affirms strong relation between tinnitus, obesity, and high lipids of blood. Read more about this study
- Who is it for?
- Ages 35 to 45 years
- Conditions the study is for
- Tinnitus, Subjective, Obesity, Lipids
- What is being tested?
- true acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Dec 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- obese patients
- tinnitus complaints (chronic subjective form)
Who cannot join
- diabetics
- cardiovascular and neurogenic manifestations
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo Unoversity
Giza
Ali Ismail, lecturer, 01005154209, allooka2012@gmail.com
About this study
nowadays, published literature affirms strong relation between tinnitus, obesity, and high lipids of blood.
Read the detailed description
For 8 weeks, our study will search effect of acupuncture on tinnitus (chronic subjective type), lipids and weight reduction in obese persons.
- Conditions
- Tinnitus, Subjective, Obesity, Lipids
- Being tested
- true acupuncture, sham acupuncture
- Medical subject headings
- Tinnitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
true acupunctureOther
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 acupunctureOther
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
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | 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. Receives: Other: true acupuncture |
| Group B | Sham comparator | 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. Receives: Other: sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
tinnitus handicap inventory
quality of life measure
Measured: It will be measured after eight weeks of acupuncture
Secondary outcomes (7)
cholesterol
serum lipid
Measured: It will be measured after eight weeks of acupuncture
triglycerides
serum lipid
Measured: It will be measured after eight weeks of acupuncture
high density lipoprotein
serum lipid
Measured: It will be measured after eight weeks of acupuncture
low density lipoproetin
serum lipid
Measured: It will be measured after eight weeks of acupuncture
body mass index
anthropometry measure
Measured: It will be measured after eight weeks of acupuncture
waist circumference
anthropometry measure
Measured: It will be measured after eight weeks of acupuncture
visual analogue scale
as a measure for severity of ear tinnitus
Measured: It will be measured after eight weeks of acupuncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start6 Dec 2021
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinnitus, SubjectiveStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188365
- Sponsor's protocol ID
- P.T.REC/012/003525
- Status last verified
- Jan 2022
- First submitted
- 27 Dec 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Efficacy on Lipids in Tinnitus Patients With Obesity
- ClinicalTrials.gov ID
- NCT05188365
- Acronym / sponsor ID
- P.T.REC/012/003525
- Conditions
- Tinnitus, Subjective, Obesity, Lipids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Other: true acupuncturedifferent 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 | Sham comparator | Other: sham acupuncturedifferent 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. |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- obese patients
- tinnitus complaints (chronic subjective form)
Key exclusion criteria (2 listed)
- diabetics
- cardiovascular and neurogenic manifestations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| true acupuncturedifferent 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 | group A |
| sham acupuncturedifferent 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 | Group B |
Primary outcome
tinnitus handicap inventory
Time frame: It will be measured after eight weeks of acupuncture
quality of life measure
7 secondary outcomes
cholesterol
Time frame: It will be measured after eight weeks of acupuncture
triglycerides
Time frame: It will be measured after eight weeks of acupuncture
high density lipoprotein
Time frame: It will be measured after eight weeks of acupuncture
low density lipoproetin
Time frame: It will be measured after eight weeks of acupuncture
body mass index
Time frame: It will be measured after eight weeks of acupuncture
waist circumference
Time frame: It will be measured after eight weeks of acupuncture
visual analogue scale
Time frame: It will be measured after eight weeks of acupuncture
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
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COMPARISON OF MANUAL THERAPY, TINNITUS RETRAINING THERAPY
Somatosensory Tinnitus, Subjektif tınnitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Ismail, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing true acupuncture in people with Tinnitus, Subjective and Obesity, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Ismail, lecturer (02 01005154209, allooka2012@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tinnitus handicap inventory (time frame: It will be measured after eight weeks of acupuncture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.