Protocol summary

Summary
Considering the increasing prevalence of diabetes in Iran and tendency of patients toward using herbal medicines instead of conventional (chemical) pharmaceuticals, the current study aimed at evaluating the effect of herbal medicine of Diabites (including nettle leaf, blackberry leaf, garlic powder, fenugreek powder, walnut leaf, and cinnamon powder) on the level of blood sugar in patients with diabetes. According to the results of the study, the intervention mainly affected fasting blood sugar (FBS), 2 hours post-prandial blood sugar (2hppBS), and hemoglobin A1c (HBA1c), followed by systolic and diastolic blood pressures, homeostasis model assessment-estimated insulin resistance (HOMA-IR), urea, creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), C-reactive protein (CRP), triglyceride (TG), cholesterol (CHOL), high-density lipoprotein (HDL), and low-density lipoprotein (LDL) as the secondary effects. The current double-blind, placebo-controlled, randomized clinical trial, a single-center study, was conducted on 76 patients with diabetes, in the age range of 25 to 70 years. The study cases included the patients with diabetes referred to the Oncology Clinic at Shahid Beheshti Hospital in Qom, Iran. The patients were the candidates for insulin injection, but had no willingness to inject. At the beginning of the study, the cases were assigned to 2 groups of experiment and placebo, by the random block sampling method. The experiment group received Diabites 3 times a day, each time 1 capsule, in addition to the previously prescribed medicines, and the placebo group received the placebo by the same program in addition to the previously prescribed medicines for 12 weeks. The inclusion criteria were: the age range of 25 to 70 years for both genders, FBS >130 mg/dL and 2hppBS >180 mg/dL; having cardiovascular, renal, and/or liver diseases were also considered as the exclusion criteria.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016011826097N1
Registration date: 2017-05-02, 1396/02/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-05-02, 1396/02/12
Registrant information
Name
Jamshid Vafaeemanesh
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 252931933
Email address
j.vafaeemanesh@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Qom University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of “ conventional medicine,blood sugar”(combination of powder of Urtica dioica leaf %20,powder of Morus nigra leaf %10,powder of Allium Sativum %20 ,powder of Trigonella foenum-graceum or Fenugreek seed%20 ,powder of Junglans Regia leaf %20 ,powder of Cinnamomum Zeylanicum %10)on the Insulin resistance of patients with Diabetes Mellitus type II
Public title
The effect of “ conventional medicine,blood sugaron the Insulin resistance of patients with Diabetes Mellitus type II
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:the age range of 25 to 70 years for both genders, FBS >130 mg/dL and 2hppBS >180 mg/dL, uncontrolled BS with two decreased BS oral drug in patient the candidates for insulin injection, but had no willingness to inject. Exclusion criteria: cardiovascular,kidney and liver disease; pregnancy; breast feeding
Age
From 25 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Qom University of Medical Sciences
Street address
Qom University of Medical Sciences Pardis، Qom
City
Qom
Postal code
3713649373
Approval date
2016-06-22, 1395/04/02
Ethics committee reference number
Ir.muq.rec.1395.42

Health conditions studied

1

Description of health condition studied
diabet mellitus type2
ICD-10 code
E11
ICD-10 code description
non-Insulin-dependent diabetes mellitus

Primary outcomes

1

Description
FBS
Timepoint
Before intervention, after 6 weeks, after intervention(after 12 weeks)
Method of measurement
blood test (Mg per deciliter)

2

Description
HbA1c
Timepoint
Before intervention, after 6 weeks, after intervention(after 12 weeks)
Method of measurement
blood test (Mg per deciliter)

3

Description
HOMA-IR
Timepoint
Before intervention, after 6 weeks, after intervention(after 12 weeks)
Method of measurement
blood test (Mg per deciliter)

Secondary outcomes

1

Description
TG
Timepoint
Before intervention, after 6 weeks, after intervention(after 12 weeks)
Method of measurement
blood test (Mg per deciliter)

2

Description
CHOL
Timepoint
Before intervention, after 6 weeks, after intervention(after 12 weeks)
Method of measurement
blood test (Mg per deciliter)

3

Description
LDL
Timepoint
Before intervention, after 6 weeks, after intervention(after 12 weeks)
Method of measurement
blood test (Mg per deciliter)

4

Description
HDL
Timepoint
Before intervention, after 6 weeks, after intervention(after 12 weeks)
Method of measurement
blood test (Mg per deciliter)

Intervention groups

1

Description
The experiment group: Diabites, an herbal medicine for the treatment of diabetes, is provided in 750 mg capsules (licensed by Iranian Ministry of Health; produced and manufactured by Booalidaroo Company, Qom, Iran). The cases in the experiment group received Diabites 3 times a day, each time 1 capsule, in addition to the previously prescribed conventional (chemical) pharmaceuticals for 12 weeks.
Category
Treatment - Drugs

2

Description
The control group: The placebo (750 mg capsules similar to the interventional herbal medicine) was given to the control group cases 3 times a day, each time 1 capsule, in addition to the previously prescribed conventional (chemical) pharmaceuticals for 12 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital in Qom
Full name of responsible person
Zahra Alsadat hosseini zefreh (Intern) and Maryam Rafiee(Intern)
Street address
Shahid Beheshti Hospital in Qom، Qom
City
Qom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Hossein Saghafi
Street address
medical School، Qom University of Medical Sciences pardis، Qom
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom University of Medical Sciences
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Mohammad Hosein Abd AlMohamadi
Street address
medical School، Qom University of Medical Sciences pardis، Qom
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom University of Medical Sciences
Proportion provided by this source
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
Qom University of Medical Sciences
Full name of responsible person
Jamshid Vafaeemanesh
Position
Specialist Internal Medicine /Board of Qom University of Medical Sciences
Other areas of specialty/work
Street address
Medical School، Qom University of Medical Sciences Pardis، Qom
City
Qom
Postal code
3713649373
Phone
+98 25 3320 9071
Fax
Email
J.vafaeemanesh@muq.ac.irJvafaeemanesh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Jamshid Vafaeemanesh
Position
Spesialist Internal Medicine
Other areas of specialty/work
Street address
Medical school، Qom University of Medical Sciences Pardis، Qom
City
Qom
Postal code
3713649373
Phone
+98 25 3320 9071
Fax
Email
J.vafaeemanesh@muq.ac.irJvafaeemanesh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Jamshid Vafaeemanesh
Position
Spesialist Internal Medicine/Board of Qom University of Medical Sciences
Other areas of specialty/work
Street address
Medical school، Qom University of Medical Sciences Pardis،Qom
City
Qom
Postal code
3713649373
Phone
+98 25 3320 9071
Fax
Email
J.vafaeemanesh@muq.ac.irJvafaeemanesh@yahoo.com
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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