Protocol summary

Summary
1: Objectives: Comparing the efficacy of therapeutic package in Traditional Medicine (diet and product medicine based on Traditional Persian Medicine) with Classical Medicine (diet based on Classical Medicine and Venustat ) in weight loss overweight patients. 2: Design: Randomized clinical trial. (single blind study) only for patients. 3: Setting and conduct: Participants are selected among female patients of Nutrition clinics in Mashhad University of Medical Sciences. After completing initial history form and Clinical examination by nutritionist and initial diagnosis of overweight is filled out a consent form by patients are referred for laboratory and anthropometric tests. 4: Participants: _The main inclusion criteria of the study are: Women between 18 and 60 years; And their Body Mass Index between 27 to 29.9 and waist circumference greater than 88 cm _The main Exclusion criteria of the study are: patients with diabetes and high blood pressure to used medicine؛ Chronic liver disease؛ Chronic renal failure؛ heavy smoker more than 20 cigarettes per day؛ Obesity caused by metabolic disorders؛ Familial obesity؛ Pregnancy؛ Lactation؛ AIDS؛ Hepatitis؛ Cancer؛ Obese patients referred to Obeity Clinics in the last 6 months؛ Patients with body composition fat and water lesser than muscle based on Bioelectrical Impedance Analyzer؛ A history of intolerance or allergy patients to honey, thyme, mastic , capticum and Nigella sativa. - Sample size: 100 patients. 5: Intervention: Participants will be treated in three groups: the first group with venustat and classical diet . second group with classical diet and dava balgham( product medicine based on Persian Traditional Medicine). The third group with traditional diet and dava balgham(product medicine based on Persian Traditional Medicine). Calorie consumption is equivalent in three group. Blinding is done only for patients. The treatment period will be three months in three groups. 6: Main outcome variables: 1) Body mass index 2) Body Composition 3) Basal Metabolism Rate 4) Laboratory Parameters (CBC, FBS, LDL, HDL,Chol,TG, BUN, Cr, T3, T4, TSH, Alt, Ast, Alkp, Fe, Zn).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016041927477N1
Registration date: 2016-07-03, 1395/04/13
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-07-03, 1395/04/13
Registrant information
Name
Liely hamidnia
Name of organization / entity
School of Persian and complementary medicine of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 3855 2189
Email address
hamidnial911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of therapeutic packeges in Traditional Medicine (diet and product medicine based on Persian Traditional Medicine) with classical Medicine (diet based on Classical Medicine and Venustat ) In weight loss overweight patients.
Public title
The effect of therapeutic models of Traditional Persian Medicine on overweight
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : َAge 18 to 60 years؛ BMI 27 to 29/9 (Kg / m2)؛ Waist circumference greater than 88 cm - Exclusion criteria : Patients with diabetes and high blood pressure to used medicine؛ Chronic diseases of the liver؛ Chronic failure of kidney؛ Heavy smoker more than 20 cigarettes per day؛ Obesity caused by metabolic disorders؛ Familial obesity؛ Pregnancy؛ Lactation؛ AIDS and Hepatitis؛ Cancer؛ Obese patients referred to clinics in the last 6 months؛ Patients with body composition fat and water lesser than muscle based on Bioelectrical impedance analyzer؛ A history of intolerance or allergy to honey, thyme, mastic , capticum and Nigella sativa .
Age
From 77 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not 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
Mashhad, University Avenue, Building Qureshi ZIP Code: 345-91375 Phone: 5-38412081 051 051 38411538 Fax: 051 38430249 E-mail: vcresearch@mums.ac.i
City
Mashhad
Postal code
Approval date
2016-06-20, 1395/03/31
Ethics committee reference number
IR.MUMS.REC.1395.166

Health conditions studied

1

Description of health condition studied
Overwieght
ICD-10 code
E65-E68
ICD-10 code description
Obesity and other hyperalimentation

Primary outcomes

1

Description
Body max Index
Timepoint
Before intervention then every two weeks until the end of the intervention.
Method of measurement
By (Body Composition Analyzer System) model Tanita

2

Description
Body Composition
Timepoint
Before intervention and three months after intervention
Method of measurement
Body Composition Analyzer System model tanita

3

Description
Basal Metabolism Rate
Timepoint
Before intervention and three months after intervention
Method of measurement
By Indirect calorimetry SETُ

Secondary outcomes

1

Description
Fast LDL
Timepoint
Before intervention and three months after intervention
Method of measurement
Fasting serum LDL concentration in mg/dl

2

Description
Fast HDL
Timepoint
Before intervention and three months after intervention
Method of measurement
Fasting serum HDL concentration in mg/dl

3

Description
Fast Blood sugar
Timepoint
Before intervention and three months after intervention
Method of measurement
Fasting serum sugar concentration in mg/dl

4

Description
Fast Cholesterol
Timepoint
Before intervention and three months after intervention
Method of measurement
Fasting serum Cholesterol concentration in mg/dl

5

Description
Fast TG
Timepoint
Before intervention and three months after intervention
Method of measurement
Fasting serum TG concentration in mg/dl

6

Description
Fast SGOT، SGPT، ALKP
Timepoint
Before intervention and three months after intervention
Method of measurement
Fasting serum SGOT .SGPT .ALKP concentration in unit/lit

7

Description
Thyroid hormones (T3 .T4 .TSH)
Timepoint
Before intervention and three months after intervention
Method of measurement
Serum Thyroid hormones concentration in ng/ml

8

Description
Fe serum concentration
Timepoint
Before intervention and three months after intervention
Method of measurement
Fasting serum Fe concentration in micg/dl

9

Description
Zn serum concentraiton
Timepoint
Before intervention and three months after intervention
Method of measurement
Fasting serum Zn concentration in micg/dl

Intervention groups

1

Description
First group: Control: Venustat: 120 mg cap: 3 cap per day for three months + Standard diet Classical Medicine for three months. (The calorie consumption is equivalent in three groups.)
Category
Treatment - Drugs

2

Description
Group 3: Second Intervention: Traditional Persian Medicine model: Traditional Persian Medicine diet. (The calorie consumption is equivalant in three groups.) + Dava Balgham. (Medicinal product based on zattaria Multiflora and Nigella Sativa، Mastic and Carum Capticum ) 5 gr 2 per day morning fasting and night before sleep for three month. m.
Category
Treatment - Drugs

3

Description
Group 2: First Intervention: Classical Medicine diet.(The calorie consumption is equivalant in three groups) + Dava balgham (Medicinal product based on zattaria multiflora and Nigella sativa and Mastic and Carum capticum ) 5 gr 2 per day morning fasting and night before sleep for three months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of School of Persian and Complementary Medicine of Mashhad
Full name of responsible person
Liely Hamidnia PHD student of Traditional Persian Medicine
Street address
East Razi street، School of Persian and Complementary medicine of Mashhad
City
Mashhad

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
Vice chancellor for research, Mashhad University of Medical Sciences, Daneshgah street
City
Mashhad
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
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
School of Persian and Complementary medicine of Mashhad
Full name of responsible person
Liely Hamidnia
Position
PHD student of Traditional Persian Medicine
Other areas of specialty/work
Street address
East Razi street
City
mashhad
Postal code
Phone
+98 51 3855 2189
Fax
Email
hamidniaL911@mums.ac.irdr.hamidnia@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Persian and Complementary medicine of Mashhad
Full name of responsible person
Malihe Motevasselian
Position
PHD of Traditional Persian Medicine
Other areas of specialty/work
Street address
East Razi street
City
Mashhad
Postal code
Phone
+98 51 3855 2188
Fax
Email
motavasselian@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Persian and Complementry medicine of Mashhad
Full name of responsible person
Liely Hamidnia
Position
PHD student of Traditional Persian Medicine
Other areas of specialty/work
Street address
East Razi Avenue oppisite Mehran hall School of Persian and Complementry of Mashhad
City
Mashhad
Postal code
91388_19344
Phone
+98 51 3855 2188
Fax
+98 38535980
Email
tim@mums.ac.ir
Web page address
http://www.mums.ac.ir/tim

Sharing plan

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