Evaluating the effects of acupuncture and embedding on anthropometric indices and inflammation biomarkers in overweight patients: a randomized placebo-controlled trial
Determining the effectiveness of acupuncture and embedding on anthropometric indices and inflammatory factors in overweight patients in comparison with placebo
Design
Randomized, controlled, phase 3, parallel groups, single blinded clinical trial on 150 overweight patients. Participants will be divided into 3 groups using block randomization method with random allocation software (SPSS). Groups 1 receives acupuncture, group 2 receives embedding and group 3 receives placebo. Participants in group 1 and 3 receive acupuncture and its placebo twice a week for 4 weeks, then once a week for next 4 weeks and for embedding 3 times: at the beginning of study, at week 3rd and 6th.
Settings and conduct
This trial will be held in Ahmadie clinic, Tehran Univerity of Medical Sciences affiliated. After informing the public, volunteers who have inclusion criteria will be divided randomly into 3 groups. Anthropometric indices will be measured at weeks 0, 4, and 8 and data will be analyzed using SPSS software.
Participants/Inclusion and exclusion criteria
Overweight patients (BMI 25-29.9) without any underlying disease, aged 25-65 years old
Intervention groups
1- Acupuncture 2- Embedding 3- Placebo
Main outcome variables
Weight; BMI
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171007036614N3
Registration date:2023-06-27, 1402/04/06
Registration timing:prospective
Last update:2023-06-27, 1402/04/06
Update count:0
Registration date
2023-06-27, 1402/04/06
Registrant information
Name
Mohammad Sadegh Adel-Mehraban
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3624 3214
Email address
sadeghadel@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of acupuncture and embedding on anthropometric indices and inflammation biomarkers in overweight patients: a randomized placebo-controlled trial
Public title
effects of acupuncture and embedding in overweight patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 25-65 years old
Overweight patients (BMI 25-29.9)
Exclusion criteria:
Pregnancy
Lactation
Any significant underlying disease (pulmonary, cardiovascular, liver, cancer, etc.)
Diet within the past 6 months
Age
From 25 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are randomly divided into 3 groups by the block randomization method (ABA, ACB, BAC, BCA, CAB, CBA). group A receives acupuncture, group B embedding, and group C placebo of acupuncture. A number from 1 to 6 will be assigned to each block. To achieve sample size, 50 numbers (blocks) will be generated by an online random number generator and participants will be assigned to the groups randomly.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will be randomly divided into 3 groups. Acupuncture and its placebo is similar and patients can not identify them but embedding is different. So totally blindness for patients and physician is not possible.
Outcomes will be measured by a third party who is not aware about group of participants and type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee/institute of Pharmaceuticals Sciences -Tehran University of Medical Sciences
Street address
Enqelab St.
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2023-03-14, 1401/12/23
Ethics committee reference number
IR.TUMS.TIPS.REC.1401.140
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Weight
Timepoint
Before treatment, after 4 weeks, and after 8 weeks
Method of measurement
Digital scale
2
Description
Body mass index
Timepoint
Before treatment, after 4 weeks, and after 8 weeks
Method of measurement
Divide weight by height squared
Secondary outcomes
1
Description
IL-6
Timepoint
Before treatment and after 8 weeks
Method of measurement
ELISA
2
Description
IL-10
Timepoint
Before treatment and after 8 weeks
Method of measurement
ELISA
Intervention groups
1
Description
Intervention group: Acupuncture. To perform acupuncture, stimulation of st40, st36, st44, lv2, lv3, st25, st26, st27, ren4, ren6, ren10, ren12, sp13-15, gb26, st32, Li13 acupoints will be performed. Acupuncture with disposable steel needles of quanqi brand size 25 x 40 are selected in acupoints based on the predominant obesity syndrome, which is sp qi def and damp. The needles are inserted vertically. In the abdominal, thigh and arm, depending on the patient's body, it is inserted between 1 to 2.5 cm, and in other areas, such as between the fingers and toes, 5 to 7 mm. Due to the predominant syndrome of patients in places such as st40, st36, st25, sp15, the tonification technique is used and in other points even technique are used. The needles stay in place for about 20 minutes. Some points such as st25, ren12, ren4, 26 gb are connected to the electrode and after 20 minutes the device is turned off, the connection is disconnected and the needles are removed. The frequency of the device will be between 10-15 Hz, depending on the patient's tolerance. The electrode will be from KWD brand and the same for patients. Each participant will receive acupuncture protocol twice a week for 4 weeks and then once a week until the end of the eighth week.
Category
Treatment - Other
2
Description
Intervention group: Embedding. Stimulation of St24-26, Ren4, Ren6, Ren10, Ren12, Kd17 in sterile condition using absorbable sutures each 3 weeks for 3 sessions (weeks 0, 3 and 6 of study) will be performed.
Category
Treatment - Other
3
Description
Control group: Acupuncture placebo. For acupuncture placebo, disposable 18 x 20 needles of quanqi brand are used. Points that are not acupoints and are at least 1 cm away from the acupoints will be selected carefully. The needle penetrates the skin up to 2 mm and even less in the hand area (only a small contact) and tries not to have a manipulation process and the needle is not deeper. To electro simulate, needles are attached to the device, the device is turned on but the patient does not receive a frequency. For this group, the needles stay in the body for 20 minutes and then come out. Each participant will visit twice a week for up to 4 weeks and then once a week until the end of the eighth week.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahmadie clinid
Full name of responsible person
Mohammad Sadegh Adel Mehraban
Street address
Taleqani St.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8897 4535
Email
sadeghadel@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotoohi
Street address
Enqelab St., Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8897 8745
Email
info@tpcf.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Adel Mehraban
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Taleqani St., Ahmadie Clinic
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8897 4535
Email
sadeghadel@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amirhooman Kazemi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Traditional Medicine
Street address
Taleqani St., Ahmadie clinic
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8897 4535
Email
amirhoomank@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Adel Mehraban
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Taleqani St., Ahmadie Clinic
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8897 4535
Email
sadeghadel@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Gathered data will be analyzed and then published.
When the data will become available and for how long
After publishing study
To whom data/document is available
Everyone (depending on the journal policies)
Under which criteria data/document could be used
Published article will be public.
From where data/document is obtainable
The journal that the paper is published in.
What processes are involved for a request to access data/document