Comparison of Integrative Medicine (acupuncture, Hypericum Perforatum and standard treatment) with standard therapy in weight loss: a randomized controlled clinical trial
(1) Objectives: to determine and compare the effect of adding acupuncture and / or Hypericum perforatum to standard treatment on weight and appetite
(2) Design: Randomized, triple blind, placebo-controlled, single-center, phase 3 trial
(3) Setting and conduct : 88 overweight or obese patients will be randomly assigned to one of four groups to be treated for 8 weeks: 1. Acupuncture + Hypericum perforatum + standard diet; 2. acupuncture + placebo Hypericum perforatum + diet; 3. Sham acupuncture + Hypericum perforatum + diet; 4. sham acupuncture + placebo Hypericum perforatum+ diet
(4) Participants People with BMI 24.9 to 39.9, women 18 years to premenopausal and men 18 to 60 years. Main exclusion criteria: 1- a disease affecting metabolism such as hypothyroidism 2- drugs affecting weight and metabolism or interfering with Hypericum perforatum 3- allergy to Hypericum perforatum or needle
(5) intervention: Acupuncture, Hypericum perforatum, standard diet of obesity
(6) main outcome measures: the appetite, anthropometric parameters, body composition, Nesfatin 1 levels, insulin levels, fasting blood sugar, side effects
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201706107265N9
Registration date:2017-06-24, 1396/04/03
Registration timing:registered_while_recruiting
Last update:
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
2017-06-22, 1396/04/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Integrative Medicine (acupuncture, Hypericum Perforatum and standard treatment) with standard therapy in weight loss: a randomized controlled clinical trial
Public title
Comparison of acupuncture, Hypericum Perforatum and standard treatment in weight loss
Purpose
Treatment
Inclusion/Exclusion criteria
Main inclusion criteria: BMI 24.9 to 39.9; Women 18 years to premenopausal and men 18 to 60 years; History of at least one monotherapy failure with diet or acupuncture.
Main exclusion criteria: hypothyroidism, Cushing's syndrome, cancer, liver or kidney failure; psychiatric disorders associated with eating like anorexia nervosa and hyperorexia; Using drugs effective on 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 abuser or alcoholism; Breast-feeding, pregnancy or planning a pregnancy during the next two months; pacemaker and any metal device inside the body due to the use of electrical devices like electroacupuncture and Bioelectrical Impedance Analyzer; disability to do recommended physical activity; Allergy to hypericum perforatum or needle; Coagulative disorders
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
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
Postal code
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
waist to hip ratio
Timepoint
before intervention, week 4, week 8
Method of measurement
Centimeter
2
Description
appetite
Timepoint
before intervention, week 4, week 8
Method of measurement
Visual Analogue Scale
3
Description
body weight
Timepoint
before intervention, week 4, week 8
Method of measurement
Kilogram
Secondary outcomes
1
Description
Nesfatin-1
Timepoint
before intervention, after intervention
Method of measurement
ng/dl
2
Description
Insulin
Timepoint
before intervention, after intervention
Method of measurement
IU
3
Description
Fasting Blood Sugar
Timepoint
before intervention, after intervention
Method of measurement
mg/dl
Intervention groups
1
Description
Acupuncture, 3 times per week + Perforan tab, 15 mg/kg/day + diet for 8 weeks
Category
Other
2
Description
Sham acupuncture, 3 times/week+Perforan tab, 15 mg/kg/day, for 8 weeks + diet for 8 weeks