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Effects of a Polyherbal compound on the level of blood lipids in diabetic patients

Protocol summary

Summary
In this clinical trial 50 patients with type-2 diabetes will enrolled in two groups containing 25 subjects. In group 1, patients will receive only oral hypoglycemic drugs (metformin and/or glibenclamide) and statins agents for control of blood glucose and lipids. In group 2, patients will receive the polyherbal compound in addition to those current drugs. Before treatment, the level of total cholesterol, LDL, VLDL, HDL, triglyceride, fasting blood Sugar, HbA1c, hepatic enzyme, BUN and creatinine will determined in venous blood samples of patients. Then, the polyherbal compound will administrate twice daily (dinner and lunch). The patient will keep the usual diabetic diet and the standard hypoglycemic medications during study. After 1, 2 and 3 months the patients will visited by physician to check vital signs, blood sugar and any possible side effects. After 1 and 3 months, the level of blood glucose, lipids, hepatic enzyme, BUN and creatinine will determined again. All parameters will measure using standard kits and autoanalyzer

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014030116776N1
Registration date: 2014-04-23, 1393/02/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-04-23, 1393/02/03
Registrant information
Name
Ahmad Ghorbani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1800 2262
Email address
ghorbania@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2014-03-11, 1392/12/20
Expected recruitment end date
2015-03-11, 1393/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of a Polyherbal compound on the level of blood lipids in diabetic patients
Public title
Effects of a Polyherbal compound on the level of blood lipids in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
1. Age: > 25 2. Non-insulin dependent diabetic patients 3. Fasting blood Sugar > 140 mg/dl and HbA1c > 7% 4. Serum Cholesterol > 200 mg/dl and Triglyceride > 150 mg/dl 5. Patients with chronic renal, hepatic or infectious diseases will be excluded. 6. Patients with history of any allergy to Garlic, Black seed, Aloe vera, fenugreek, Psyllium and Silybum marianum will be excluded. 7. No addiction to cigarette, alcohol or any other drugs.
Age
From 25 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Daneshgah St.
City
Mashhad
Postal code
Approval date
2013-10-19, 1392/07/27
Ethics committee reference number
911068

Health conditions studied

1

Description of health condition studied
Diabetic Dyslipidemia
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Cholestrol and triglyceride
Timepoint
At the begining of study as well as after1 and 3 months
Method of measurement
Standard Kits

Secondary outcomes

empty

Intervention groups

1

Description
Patients in this group will receive atorvastatin (20 mg, once a day) drug plus placebo for decrease of serum lipids for 3 months.
Category
Placebo

2

Description
Patients in this group will receive atrovastatin drug plus polyherbal compound. The compound is prepared as sachet (8.7g) containing powder of Allium sativum, Nigella sativa, Trigonella foenum, Psyllium, silybum marinum and Aloe vera. The compound will administrate twice daily for 3 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of Emam Reza Hospital
Full name of responsible person
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Council of Mashhad University of Medical Sciences, Mashhad, IRAN
Full name of responsible person
Mohammad Ramezani
Street address
Ghoraishi Building, University st.
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Mashhad University of Medical Sciences, Mashhad, IRAN
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
Mashhad University of Medical Sciences
Full name of responsible person
Hassan Rakhshandeh
Position
Assistant Professor in Pharmacology
Other areas of specialty/work
Street address
School of Medicine, Azadi Square
City
Mashhad
Postal code
Phone
+98 51 1800 2259
Fax
Email
rakhshandehh@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ahmad Ghorbani
Position
Assistant Professor in Physiology
Other areas of specialty/work
Street address
School of Medicine, Azadi Square
City
Mashhad
Postal code
Phone
+98 51 1800 2262
Fax
Email
ghorbania@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Pharmacological Research Center of Medicinal Plants, School of Medicine, Mashhad University of Medic
Full name of responsible person
Ahmad Ghorbani
Position
Assistant professor
Other areas of specialty/work
Street address
School of Medicine, Azadi Square
City
Mashhad
Postal code
9177948564
Phone
+98 51 1800 2262
Fax
Email
ghorbania@mums.ac.ir
Web page address

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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