Protocol summary

Study aim
Comparison of the effect of Hypericum perforatum or placebo to standard therapy in reducing appetite and weight
Design
Phase 3 controlled clinical trials, community-based and pragmatic, parallel group, double-blind, randomized with sample size 60
Settings and conduct
Patients are selected among ones who refer to Chinese medicine and acupuncture clinic of Imam Reza Hospital. After reviewing the inclusion criteria, obtaining the informed consent and filling out the research checklist, the patient will be visited by a nutritionist to receive a diet and recommendations for exercise. Then, depending on the assigned group, he receives hypericum perforatum or a placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: BMI 24.9 to 40; Women 18 years to premenopausal and men 18 to 60 years old Exclusion criteria: Hypothyroidism; Cushing's syndrome; cancer; liver or kidney failure; Psychiatric disorders associated with eating; Using drugs interfering with Hypericum perforatum or effective on weight and metabolism in the previous month; Allergy to hypericum perforatum
Intervention groups
Experimental group: Hypericum perforatum plus diet plus exercise Control group: placebo plus diet plus exercise
Main outcome variables
Appetite; Weight; Anthropometric measures

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110809007265N12
Registration date: 2018-06-30, 1397/04/09
Registration timing: registered_while_recruiting

Last update: 2018-06-30, 1397/04/09
Update count: 0
Registration date
2018-06-30, 1397/04/09
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
Expected recruitment start date
2018-05-26, 1397/03/05
Expected recruitment end date
2018-07-27, 1397/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of hypericum perforatum with placebo in appetite control in obese and overweight individuals
Public title
Effect of hypericum perforatum in obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
BMI 24.9 to 39.9 Women 18 years to premenopausal and men 18 to 60 years old Consent to participate in the study History of at least one monotherapy failure
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 Bioelectrical Impedance Analyzer Disability to do recommended physical activity Allergy to hypericum perforatum
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomisation using number cards in sealed envelopes
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, major researcher, nutritionist, questioner, data analyst
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
2018-05-19, 1397/02/29
Ethics committee reference number
IR.MUMS.REC.1397.046

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
Appetite
Timepoint
Before intervention, week 3, week 6
Method of measurement
Visual Analogue Scale

2

Description
Body weight
Timepoint
Before intervention, week 3, week 6
Method of measurement
Kilogram

3

Description
Waist to hip ratio
Timepoint
Before intervention, week 3, week 6
Method of measurement
Centimeter

Secondary outcomes

1

Description
Insulin
Timepoint
Before intervention, after intervention
Method of measurement
IU

2

Description
Fasting Blood Sugar
Timepoint
Before intervention, after intervention
Method of measurement
Mg/dl

Intervention groups

1

Description
Intervention group: diet + exercise + Hypericum perforatum 750 mg QID for 6 weeks (made by School of Iranian and Complementary Medicine, Mashhad)
Category
Treatment - Drugs

2

Description
Control group: diet + exercise + placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Chinese and Complementary Medicine clinic, Imam Reza Hospital
Full name of responsible person
Dr. Hoda Azizi
Street address
Chinese Medicine and acupuncture clinic, Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
azizih@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Deputy for research office, Mashhad University of Medical Sciences, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91357345
Phone
+98 51 3841 2981
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
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
Mashhad University of Medical Sciences
Full name of responsible person
Hoda Azizi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Complementary Medicine
Street address
School of Iranian and Complementary Medicine, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 1855 2188
Fax
Email
azizih@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Hoda Azizi
Position
MD, PhD in Acupuncture, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Complementary Medicine
Street address
School of Iranian and Complementary Medicine, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3855 2188
Fax
Email
azizih@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Hoda Azizi
Position
MD, PhD in Acupuncture, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Complementary Medicine
Street address
School of Iranian and Complementary Medicine, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3855 2188
Fax
Email
azizih@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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