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Comparison of integrative medicine (acupuncture, Hypericum perforatum and life style modification) with life style modification in appetite and weight control

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History
# Registration date Revision Id
3 2019-09-01, 1398/06/10 103874
2 2018-08-18, 1397/05/27 60471
1 2017-06-24, 1396/04/03 7704
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  • Protocol summary

    Nesfatin 1 levels؛ the appetite score; BMI; waist circumference; hip circumference; body composition
    BMI; the appetite score; Nesfatin 1 level; waist circumference; hip circumference; body composition
    سطح نسفاتین 1؛ میزان اشتها؛ شاخص توده بدنی؛ دور کمر؛ دور هیپ؛ ترکیب بدن
    شاخص توده بدنی؛ میزان اشتها؛ سطح نسفاتین 1؛ دور کمر؛ دور هیپ؛ ترکیب بدن

  • General information

    Triple blinded
    Single blinded
    2018-10-23, 1397/08/01
    2019-11-01, 1398/08/10
    Appetite score more than 4 according to visual analogue scale
    Body mass index between 24.9 to 39.9
    Women 18 years old to pre-menopause; men 18 to 60 years old
    Failure to life style modification alone
    "Liver qi stagnation" syndrome according to Chinese Medicine syndrome differentiation
    Appetite score more than 5 according to visual analogue scale
    Body mass index between 24.9 to 39.9
    Women 18 years old to pre-menopause; men 18 to 60 years old
    Failure to life style modification alone
    "Liver qi stagnation" syndrome according to Chinese Medicine syndrome differentiation
    اسکور اشتهای بیشتر از 4 بر اساس مقیاس دیداری
    شاخص توده بدنی 24.9 تا 39.9
    خانم های 18 ساله تا پره منوپوز؛ آقایان 18 تا 60 سال
    شکست در تغییر شیوه زندگی به تنهایی
    سندرم "رکود چی کبدی" بر اساس سندرم شناسی طب چینی
    اسکور اشتهای بیشتر از 5 بر اساس مقیاس دیداری
    شاخص توده بدنی 24.9 تا 39.9
    خانم های 18 ساله تا پره منوپوز؛ آقایان 18 تا 60 سال
    شکست در تغییر شیوه زندگی به تنهایی
    سندرم "رکود چی کبدی" بر اساس سندرم شناسی طب چینی
    empty
    empty

  • Primary outcomes

    #1
    empty
    Appetite score
    empty
    نمره اشتها
    empty
    Before intervention, weeks 2, 4, 6, 24
    empty
    قبل از شروع مداخله، در هفته 2، 4، 6، 24
    empty
    Visual Analogue Scale
    empty
    مقیاس دیداری
    #2
    empty
    Body Mass Index
    empty
    شاخص توده بدنی
    empty
    Before intervention, weeks 2, 6, 24
    empty
    قبل از شروع مداخله، هفته 2، 6 و 24
    empty
    Using the bioelectrical impedance analyzer; kg/m2
    empty
    با استفاده از دستگاه آنالیز بدن؛ بر حسب کیلوگرم بر متر مربع

  • Secondary outcomes

    #1
    Appetite score
    Waist circumference
    نمره اشتها
    دور کمر
    Before intervention, weeks 2, 4, 6, 24
    Before intervention, weeks 2, 6, 24
    قبل از شروع مداخله، در هفته 2، 4، 6، 24
    قبل از شروع مداخله، هفته 2، 6 و 24
    Visual Analogue Scale
    Using a tape measure; centimeters
    مقیاس دیداری
    با استفاده از متر نواری؛ بر حسب سانتی متر
    #2
    Body Mass Index
    Hip circumference
    شاخص توده بدنی
    دور هیپ
    Using the bioelectrical impedance analyzer; kg/m2
    Using a tape measure; centimeters
    با استفاده از دستگاه آنالیز بدن؛ بر حسب کیلوگرم بر متر مربع
    با استفاده از متر نواری؛ بر حسب سانتی متر
    #3
    Waist circumference
    Body composition
    دور کمر
    ترکیب بدن
    Before intervention, weeks 2, 6, 24
    Before intervention, weeks 2, 6
    قبل از شروع مداخله، هفته 2، 6 و 24
    قبل از شروع مداخله، هفته 2 و 6
    Using a tape measure; centimeters
    Using the bioelectrical impedance analyzer
    با استفاده از متر نواری؛ بر حسب سانتی متر
    با استفاده از دستگاه آنالیز بدن
    #4
    Hip circumference
    Lipid profile
    دور هیپ
    پروفایل لیپیدی
    Before intervention, weeks 2, 6, 24
    Before intervention, week 6
    قبل از شروع مداخله، هفته 2، 6 و 24
    قبل از شروع مداخله، هفته 6
    Using a tape measure; centimeters
    Laboratory
    با استفاده از متر نواری؛ بر حسب سانتی متر
    آزمایشگاهی
    #5
    Body composition
    Liver enzymes
    ترکیب بدن
    آنزیم های کبدی
    Before intervention, weeks 2, 6
    Before intervention, week 6
    قبل از شروع مداخله، هفته 2 و 6
    قبل از شروع مداخله، هفته 6
    Using the bioelectrical impedance analyzer
    Laboratory
    با استفاده از دستگاه آنالیز بدن
    آزمایشگاهی
    #6
    Lipid profile
    Blood glucose level
    پروفایل لیپیدی
    سطح قند خون
    #7
    Liver enzymes
    Adverse events
    آنزیم های کبدی
    عوارض جانبی
    Before intervention, week 6
    During the study period within 48 to 72 hours of incidence; week 6
    قبل از شروع مداخله، هفته 6
    در طول مطالعه در فاصله 48 تا 72 ساعت از زمان بروز؛ هفته 6
    Laboratory
    Study checklist
    آزمایشگاهی
    چک لیست مطالعه
    #8
    Blood glucose level
    empty
    سطح قند خون
    empty
    Before intervention, week 6
    empty
    قبل از شروع مداخله، هفته 6
    empty
    Laboratory
    empty
    آزمایشگاهی
    empty
    #9
    Adverse events
    empty
    عوارض جانبی
    empty
    During the study period within 48 to 72 hours of incidence; week 6
    empty
    در طول مطالعه در فاصله 48 تا 72 ساعت از زمان بروز؛ هفته 6
    empty
    Study checklist
    empty
    چک لیست مطالعه
    empty

  • Intervention groups

    #1
    Intervention group 1: acupuncture, 3 times per week + 4 Hypericum perforatum capsules (equivalent to 400 mg/day extract) + life style modification for 6 weeks
    Intervention group 1: acupuncture, 3 times per week + 4 tablets of 160 mg Perforan (Goldaru company) + life style modification for 6 weeks
    گروه مداخله 1: طب سوزنی، سه بار در هفته + 4 عدد کپسول هوفاریقون در روز (معادل 400 میلی گرم عصاره در روز) + تغییر شیوه زندگی به مدت 6 هفته
    گروه مداخله 1: طب سوزنی، سه بار در هفته + 4 عدد قرص پرفوران 160 میلی گرمی (شرکت گل دارو) + تغییر شیوه زندگی به مدت 6 هفته
    #2
    Intervention group 2: acupuncture 3 times/week + placebo capsules + life style modification for 6 weeks
    Intervention group 2: acupuncture 3 times/week + placebo tablets+ life style modification for 6 weeks
    گروه مداخله 2: طب سوزنی، 3 بار در هفته+ کپسول پلاسبو + تغییر شیوه زندگی به مدت 6 هفته
    گروه مداخله 2: طب سوزنی، 3 بار در هفته+ قرص پلاسبو + تغییر شیوه زندگی به مدت 6 هفته
    #3
    Intervention group 3: sham acupuncture, 3 times/week+ 4 Hypericum perforatum capsules (equivalent to 400 mg/day extract) + life style modification for 6 weeks
    Intervention group 3: sham acupuncture, 3 times/week+ 4 tablets of 160 mg Perforan (Goldaru company) + life style modification for 6 weeks
    گروه مداخله 3: طب سوزنی شم، 3 بار در هفته + 4 عدد کپسول هوفاریقون در روز (معادل 400 میلی گرم عصاره در روز) + تغییر شیوه زندگی به مدت 6 هفته
    گروه مداخله 3: طب سوزنی شم، 3 بار در هفته + 4 عدد قرص پرفوران 160 میلی گرمی (شرکت گل دارو) + تغییر شیوه زندگی به مدت 6 هفته

Protocol summary

Study aim
To determine and compare the effect of adding acupuncture and / or Hypericum perforatum to life style modification in appetite and weight control
Design
A randomized, sham controlled, parallel group, phase III clinical trial with blinded patients, nutritionist, outcome assessor and statistician
Settings and conduct
Eighty-eight overweight or obese patients with appetite score ≤ 5 out of 10 will be randomly assigned to one of four groups to be treated for 6 weeks in the acupuncture and nutrition clinics affiliated to Mashhad University of Medical Sciences. Patients, nutritionist, outcome assessor and statistician will be blinded to study groups. acupuncturist could not be blinded in this study.
Participants/Inclusion and exclusion criteria
Main inclusion criteria: People with BMI 24.9 to 39.9; women 18 years to premenopausal and men 18 to 60 years. Main exclusion criteria: 1- ِdiseases affecting metabolism such as hypothyroidism 2- drugs affecting weight and metabolism or interfering with Hypericum perforatum 3- allergy to hypericum perforatum or metal
Intervention groups
1. Acupuncture + Hypericum perforatum + life style modification; 2. acupuncture + placebo + life style modification; 3. Sham acupuncture + Hypericum perforatum + life style modification; 4. sham acupuncture + placebo + life style modification
Main outcome variables
BMI; the appetite score; Nesfatin 1 level; waist circumference; hip circumference; body composition

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT201706107265N9
Registration date: 2017-06-24, 1396/04/03
Registration timing: prospective

Last update: 2019-09-17, 1398/06/26
Update count: 2
Registration date
2017-06-24, 1396/04/03
Registrant information
Name
Hoda Azizi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1855 2188
Email address
azizih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2019-11-01, 1398/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of integrative medicine (acupuncture, Hypericum perforatum and life style modification) with life style modification in appetite and weight control
Public title
The effect of acupuncture, hypericum perforatum and diet in appetite and weight control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Appetite score more than 5 according to visual analogue scale Body mass index between 24.9 to 39.9 Women 18 years old to pre-menopause; men 18 to 60 years old Failure to life style modification alone "Liver qi stagnation" syndrome according to Chinese Medicine syndrome differentiation
Exclusion criteria:
Hypothyroidism, Cushing's syndrome, cancer, liver or kidney failure Using drugs effective on appetite, weight and metabolism in the previous month Using drugs that interfere with Hypericum perforatum such as protease inhibitors, amiodarone, anticoagulants, cyclophosphamide, cyclosporine, monoamine oxidase inhibitors, phenytoin, tacrolimus, tamoxifen and trazodone drug Drug abuse or alcoholism Breast-feeding, pregnancy or planning a pregnancy during the next two months Having pacemaker or any other metal device inside the body due to the use of electroacupuncture and Bioelectrical Impedance Analyzer disability to do recommended physical activity Allergy to Hypericum perforatum or metal Coagulation disorders History of receiving acupuncture
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be done using SPSS version 16 by selecting quadrants blocks.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants, the nutritionist, the outcome assessor, and the statistician will be blinded from the identity of the study groups. The acupuncturist will not be blinded. The participant blindness will be performed using sham acupuncture and placebo.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Qorashi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91357345
Approval date
2017-06-06, 1396/03/16
Ethics committee reference number
IR.MUMS.REC.1396.43

Health conditions studied

1

Description of health condition studied
obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
Plasma nesfatin-1
Timepoint
Before intervention, Sixth week
Method of measurement
Laboratory: ELISA

2

Description
Appetite score
Timepoint
Before intervention, weeks 2, 4, 6, 24
Method of measurement
Visual Analogue Scale

3

Description
Body Mass Index
Timepoint
Before intervention, weeks 2, 6, 24
Method of measurement
Using the bioelectrical impedance analyzer; kg/m2

Secondary outcomes

1

Description
Waist circumference
Timepoint
Before intervention, weeks 2, 6, 24
Method of measurement
Using a tape measure; centimeters

2

Description
Hip circumference
Timepoint
Before intervention, weeks 2, 6, 24
Method of measurement
Using a tape measure; centimeters

3

Description
Body composition
Timepoint
Before intervention, weeks 2, 6
Method of measurement
Using the bioelectrical impedance analyzer

4

Description
Lipid profile
Timepoint
Before intervention, week 6
Method of measurement
Laboratory

5

Description
Liver enzymes
Timepoint
Before intervention, week 6
Method of measurement
Laboratory

6

Description
Blood glucose level
Timepoint
Before intervention, week 6
Method of measurement
Laboratory

7

Description
Adverse events
Timepoint
During the study period within 48 to 72 hours of incidence; week 6
Method of measurement
Study checklist

Intervention groups

1

Description
Intervention group 1: acupuncture, 3 times per week + 4 tablets of 160 mg Perforan (Goldaru company) + life style modification for 6 weeks
Category
Other

2

Description
Intervention group 2: acupuncture 3 times/week + placebo tablets+ life style modification for 6 weeks
Category
Other

3

Description
Intervention group 3: sham acupuncture, 3 times/week+ 4 tablets of 160 mg Perforan (Goldaru company) + life style modification for 6 weeks
Category
Other

4

Description
Control group: sham acupuncture, 3 times/week + placebo + life style modification for 6 weeks
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Acupuncture clinic, Imam Reza Hospital
Full name of responsible person
Dr. Hoda Azizi
Street address
Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2035
Email
azizih@mums.ac.ir

2

Recruitment center
Name of recruitment center
Nutrition clinic, Qaem Hospital
Full name of responsible person
Dr. Mohammad Safarian
Street address
Ahmadabad Street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9919991766
Phone
+98 51 3845 3239
Email
safarianm@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Qorashi Building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91357345
Phone
+98 51 3841 2081
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad 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
School of Traditional and Complementary Medicine
Full name of responsible person
Dr. Monirsadat Sahebkar Khorasani
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Pardis daneshgah, Park Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 9279
Fax
Email
sahebkarm931@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Traditional and Complementary Medicine, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Hoda Azizi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
acupuncture and Chinese Medicine
Street address
Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 9279
Fax
Email
azizih@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Traditional and Complementary Medicine
Full name of responsible person
Dr. Monirsadat Sahebkar-khorasani
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Park Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 9279
Fax
Email
sahebkarm931@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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