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The study randomized clinical trial for comparing the effect of herbal supplement based on traditional medicine versus placebo with weight loss diet on some biochemical parameters & Anthropometric indices in obese subjects

Protocol summary

Summary
The study is a randomized double-blind clinical trial for comparing the effect of herbal supplement based on traditional medicine versus placebo with weight loss diet on some biochemical parameters and Anthropometric indices in obese subjects. Patients with a BMI more than 30 and age range 20-50 years old will be included. The study aim is gradual weight loss that will maintain ideal body weight. In this study drug on traditional Iranian medicine (buali-formula composed of Carum carvi, Origanum vulgare, Ruta Graveolen, Trachyspermum copticum; component equal weight to mixed) is investigated. In this clinical trial, 68 participation (34 patients receiving the drug group and 34 in the control group) according to random allocation inclusion and exclusion criteria will berecruited for two months. The medication will be used as much as 3 capsules for daily. The control group received placebo 3 a daily. All the participants will complete the consent form. Probable side effects will be assessment during intervention and assessment of Primary outcome is control at base line, 4weeks, 8 weeks and after intervention. Primary outcome are: weight, waist and hip circumference and secondary outcome are include [Fasting blood glucose, Cretinine, Cholesterol,Triglyceride, high-density lipoprotein, low- density lipoprotein, Uric acid, ‭hs-CRP, IL-6, ‭TNFα, Leptin, grelin] assessment at entry and end of intervention. In addition to completing on arrival the General temperament of intervention and Nutrition counseling and completion of a 3-day food records and supply information in the entry and end of study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201307272017N17
Registration date: 2014-06-04, 1393/03/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-06-04, 1393/03/14
Registrant information
Name
Alireza Ostadrahimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
ostadrahimi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-05-31, 1393/03/10
Expected recruitment end date
2014-06-20, 1393/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study randomized clinical trial for comparing the effect of herbal supplement based on traditional medicine versus placebo with weight loss diet on some biochemical parameters & Anthropometric indices in obese subjects
Public title
Effect of herbal supplement based on traditional medicine versus placebo with weight loss diet on some biochemical parameters & Anthropometric indices in obese subjects
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having BMI more than or equal 30; Age between 20 to 50 years old; Inform consent signed by the patient; Those who can over the next two months two times refer for take drugs and laboratory examination ; Waist circumference > 102 cm (men) or > 88 cm (women). Exclusion Criteria: Inform consent not signed by the patient; Those who can not over the next two months two times refer for take drugs and laboratory examination; Heavy Smoking(More than twenty cigarettes per daily); Diabetes mellitus; Patients with coronary heart vascular disease ;Patients with proven malignancy; Asthma; Chronic cough; Chronic lung inflammatory and bowel disease; Fever of unknown origin; Patients with a history of chronic kidney and liver disease(Exception fatty liver and not including obesity, allergies, skin problems, or occasional GERD or IBS symptoms); Obesity due to endocrine (hypothyroidism, uncontrolled disease) disease.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization is performed by permuted block randomization (block size: 4) using RAS software.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Science
Street address
Nutrition Research Center,Tabriz University of Medical Science, Tabriz
City
Tabriz
Postal code
5166614711
Approval date
2014-01-27, 1392/11/07
Ethics committee reference number
1424/4/5

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
Anthropometric measurements
Timepoint
2 Times during the study: at the beginning and end of intervention
Method of measurement
Anthropometric measurements including weight using calibrated Seca scale with a precision of 0/1 kg and a minimum of clothes in the morning, height, waist and hip circumference using a tape measure with an accuracy of 0.1 cm, and Bio Mass Index and waist-hip ratio was calculated.

2

Description
Body composition
Timepoint
2 Times during the study: at the beginning and end of each intervention month
Method of measurement
Measurement of body composition, including fat mass, fat free mass and total body water determination using Bioelectric Impedance Analyzer ( BIA).

3

Description
Energy and nutrient intake
Timepoint
3 Times; at first, midst and the end of intervention
Method of measurement
3 Dayes food record was used and analyzed with Nutritionist 4 software

Secondary outcomes

1

Description
Fasting srum lipid profile (Low Density Lipoprotein,High Density Lipoprotein,total cholesterol,Three Glycerid)
Timepoint
Before and after intervention
Method of measurement
Enzymatic method for total cholesterol, triglyceride and High Density Lipoprotein and Freidwald’s formula forLow Density Lipoprotein.c

2

Description
Hepatic Enzyms
Timepoint
Before and after intervention
Method of measurement
kits

3

Description
Dertemining of Uric acid, Cratinin, Bilirubin
Timepoint
Before and after intervention
Method of measurement
kits

4

Description
Serum inflammatory values (Inter lukine-6, Tumor necrosis factors-α, High-sensitivity C-reactive Protein)
Timepoint
Before and after intervention
Method of measurement
High-sensitivity C-reactive Protein assess with Immunotorbidometric method and Inter lukine-6, Tumor necrosis factors-α with Eliza method

5

Description
Serum levels of leptin, Grelin
Timepoint
Befor and after intervention
Method of measurement
By Laboratory ELISA Kits

Intervention groups

1

Description
3 grams powdered dry(Origanum vulgare,Carum carvi,Trachyspermum copticum,Ruta Graveolen)as 3 capsuls per day for two months
Category
Treatment - Drugs

2

Description
3 grams powdered corn starch as 3 capsuls per day for 60 day
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Sheykhorraeis clinic in Tabriz
Full name of responsible person
Einollah Valizadeh
Street address
Sheykhorraeis clinic in Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Nutrition Research Center
Full name of responsible person
Dr. Alireza Ostadrahimi
Street address
Faculty of Nutrition, Golgasht Street, Attar neishaboori Avenue
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nutrition Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Einollah valizadeh
Position
Ph.D Student
Other areas of specialty/work
Street address
Nutrition Research Center, Attare Neishabouri Avenue, Golgasht street, Tabriz
City
Tabriz
Postal code
5166614711
Phone
+98 41 1335 2295
Fax
+98 33 52295
Email
evalizade@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nutrition Research Center,Tabriz University of Medical Science
Full name of responsible person
Alireza Ostadrahimi
Position
Associate professor
Other areas of specialty/work
Street address
Nutrition Research Center, Tabriz University of Medical Sciences
City
Tabriz
Postal code
5166614711
Phone
+98 41 1335 2295
Fax
+98 33 52295
Email
ostadrahimi@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Einollah Valizadeh
Position
Ph.D Student
Other areas of specialty/work
Street address
Nutrition Research Center, Tabriz University of Medical Sciences
City
Tabriz
Postal code
5166614711
Phone
+98 41 1335 2295
Fax
+98 33 52295
Email
evalizade@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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