Protocol summary
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Study aim
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To determine and compare the effect of adding acupuncture and / or Hypericum perforatum to life style modification in appetite and weight control
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Design
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A randomized, sham controlled, parallel group, phase III clinical trial with blinded patients, nutritionist, outcome assessor and statistician
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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BMI; the appetite score; Nesfatin 1 level; waist circumference; hip circumference; body composition
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2017-06-24, 1396/04/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research, Mashhad University of Medical Sciences
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Expected recruitment start date
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2017-10-23, 1396/08/01
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Expected recruitment end date
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2019-11-01, 1398/08/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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The effect of acupuncture, hypericum perforatum and diet in appetite and weight control
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
88
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization will be done using SPSS version 16 by selecting quadrants blocks.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-06-06, 1396/03/16
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Ethics committee reference number
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IR.MUMS.REC.1396.43
Health conditions studied
1
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Description of health condition studied
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obesity
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ICD-10 code
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E66.0
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ICD-10 code description
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Obesity due to excess calories
Primary outcomes
1
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Description
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Plasma nesfatin-1
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Timepoint
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Before intervention, Sixth week
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Method of measurement
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Laboratory: ELISA
2
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Description
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Appetite score
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Timepoint
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Before intervention, weeks 2, 4, 6, 24
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Method of measurement
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Visual Analogue Scale
3
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Description
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Body Mass Index
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Timepoint
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Before intervention, weeks 2, 6, 24
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Method of measurement
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Using the bioelectrical impedance analyzer; kg/m2
Secondary outcomes
1
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Description
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Waist circumference
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Timepoint
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Before intervention, weeks 2, 6, 24
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Method of measurement
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Using a tape measure; centimeters
2
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Description
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Hip circumference
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Timepoint
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Before intervention, weeks 2, 6, 24
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Method of measurement
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Using a tape measure; centimeters
3
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Description
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Body composition
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Timepoint
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Before intervention, weeks 2, 6
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Method of measurement
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Using the bioelectrical impedance analyzer
4
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Description
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Lipid profile
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Timepoint
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Before intervention, week 6
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Method of measurement
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Laboratory
5
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Description
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Liver enzymes
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Timepoint
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Before intervention, week 6
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Method of measurement
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Laboratory
6
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Description
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Blood glucose level
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Timepoint
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Before intervention, week 6
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Method of measurement
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Laboratory
7
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Description
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Adverse events
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Timepoint
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During the study period within 48 to 72 hours of incidence; week 6
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Method of measurement
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Study checklist
Intervention groups
1
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Description
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Intervention group 1: acupuncture, 3 times per week + 4 tablets of 160 mg Perforan (Goldaru company) + life style modification for 6 weeks
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Category
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Other
2
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Description
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Intervention group 2: acupuncture 3 times/week + placebo tablets+ life style modification for 6 weeks
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Category
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Other
3
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Description
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Intervention group 3: sham acupuncture, 3 times/week+ 4 tablets of 160 mg Perforan (Goldaru company) + life style modification for 6 weeks
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Category
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Other
4
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Description
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Control group: sham acupuncture, 3 times/week + placebo + life style modification for 6 weeks
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Category
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Lifestyle
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for research, Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available