Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/05/2017
Date assigned
12/06/2017
Last edited
12/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Type 2 diabetes mellitus (T2DM) is a long term condition where a person is unable to control their blood sugar (glucose) levels as they do not produce enough insulin to function properly (insulin deficiency), or that the body’s cells don’t react to insulin as they should do (insulin resistance). It is becoming increasingly common and represents a major global health concern. Conventional treatment for T2DM usually involves injecting insulin or taking pills to help control blood sugar levels, however these methods are not always effective. In this context there is renewed interest in evaluating the effects of traditional herbal therapies which have been used, in some cases, for millennia. The aim of this study is to look at the effects of a new herbal combination called SR2004 in patients with T2DM.

Who can participate?
Adults with T2DM

What does the study involve?
Participants in the study continue with their usual diets, exercise regimes and medicines. All participants are treated with SR2004. This is made up from mulberry, artemisia, nettle, cinnamon bark and dandelion. Patients are treated by mouth in the form of either a syrup or capsule three times a day for 12 weeks. At the start of the study and after 12 weeks of treatment, participants have blood samples collected to measure their blood sugar control and the level of fat in the blood. In addition, any side effects from the supplement are recorded.

What are the possible benefits and risks of participating?
Participants may benefit from a lowering of blood sugar and fats as well as benefiting from close monitoring of their diabetes. There are no notable risks involved with participating.

Where is the study run from?
D.S.Polyclinic (Isreal)

When is study starting and how long is it expected to run for?
February 2008 to February 2010

Who is funding the study?
Maccabi Healthcare Services (Isreal)

Who is the main contact?
Dr Dov Fogel
foge.dov@gmail.com

Trial website

Contact information

Type

Public

Primary contact

Dr Dov Fogel

ORCID ID

http://orcid.org/0000-0002-8134-8839

Contact details

D.S.Polyclinic
22 Ben Gurion Street
Givat Shmuel
Tel Aviv
54017
Israel
+972 35 325 888
foge.dov@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

918

Study information

Scientific title

Single arm, non-blinded study assessing the effect of the novel herbal composition SR2004 on the primary endpoint haemoglobin A1c and secondary endpoints fasting blood glucose, and lipid profile in type 2 diabetic patients recruited in Israel over a 12 week period

Acronym

Study hypothesis

Does supplementation with the compound SR2004
1. Reduce blood haemoglobin A1c (HbA1c) by >1% after 12 weeks compared to Week 0?
2. Reduce fasting blood glucose by a significant level at 12 weeks compared to Week 0?
3. Reduce blood total cholesterol and triglycerides by a significant level at 12 weeks compared to Week 0?
4. Result in an acceptable side effect and safety profile?

Ethics approval

Helsinki committee of Maccabi Health Services, 21/08/2008, ref: 20080395

Study design

Single-centre unblinded single arm interventional study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Type 2 diabetes mellitus

Intervention

All patients included in the study continue their usual diets, exercise regimes and medical treatments. They will receive SR2004 at dose 300 millilitres three times daily taken 30 minutes before mealtimes (or a capsule form 500 milligram per capsule, dose two capsules three times daily, thirty minutes before meals). SR2004 supplements will be continued for 12 weeks, with weekly clinical reviews by the trial physician during this time. Patients are encouraged to attend a follow up visit at week 24 to reassess clinical and blood parameters off SR2004 supplementation.

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

Glycated hemoglobin (HbA1c) is measured using the glycated hemoglobin test on blood samples collected at baseline and 12 weeks.

Secondary outcome measures

1. Fasting blood glucose is assessed by laboratory blood glucose test at baseline nd thereafter weekly up to week 12
2. Blood total cholesterol and triglyceride levels are assessed by laboratory lipid profile blood test at pre-enrolment (week -2), 6 and 12 weeks
3. Safety and side effect information is assessed by patient interview (weekly from baseline to week 12), review of patient-recorded blood sugar measurements (weekly from baseline to week 12), clinical examination (at baseline, 6 and 12 weeks) and review of blood chemistry and blood counts (6 and 12 weeks)

Overall trial start date

01/02/2008

Overall trial end date

01/02/2010

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Confirmed diagnosis of T2DM and any combination of oral hypoglycemics and/or insulin
2. HbA1c 7.1–10% in the last 6 months
3. Body mass index (BMI) <45 kg/m2
4. Ability to provide written informed consent
5. No participation in an investigational drug study (or use of herbal supplementation) within the prior 30 days
6. Women of childbearing age are required to have a negative pregnancy test and use contraception for the duration of the trial
7. Aged 18 years and over

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Minimum required sample size of 90.

Participant exclusion criteria

1. Type 1 diabetes mellitus
2. Treatment with the drugs acarbose or rosiglitazone for more than 2 weeks in the last six months
3. Concomitant malignancy
4. Concomitant heart failure grade 2-4 (American Heart Association)
5. Liver dysfunction (alanine aminotransferase or aspartate aminotransferase more than 3 times upper limit of normal values) 6. Renal failure (serum creatinine more than 1.3 times upper limit normal for women and 1.4 for men)
7. History of severe psychiatric illness on medication

Recruitment start date

01/09/2008

Recruitment end date

01/12/2009

Locations

Countries of recruitment

Israel

Trial participating centre

D.S.Polyclinic
22 Ben Gurion Street Givat Shmuel
Tel Aviv
54017
Israel

Sponsor information

Organisation

Maccabi Healthcare Services

Sponsor details

27 HaMered Street
Tel Aviv
6812509
Israel

Sponsor type

Hospital/treatment centre

Website

http://www.maccabi4u.co.il

Funders

Funder type

Hospital/treatment centre

Funder name

Maccabi Healthcare Services

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer-reviewed journal.

IPD Sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Dov Fogel (foge.dov@gmail.com)

Intention to publish date

01/12/2017

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes