A study investigating the effect over 12 weeks of the novel herbal composition SR2004 on haemoglobin A1c, fasting blood glucose and lipids in type 2 diabetic patients
| ISRCTN | ISRCTN12562776 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12562776 |
| Secondary identifying numbers | 918 |
- Submission date
- 27/05/2017
- Registration date
- 12/06/2017
- Last edited
- 11/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Public
D.S.Polyclinic
22 Ben Gurion Street
Givat Shmuel
Tel Aviv
54017
Israel
 ORCID ID |
0000-0002-8134-8839 |
|---|---|
| Phone | +972 35 325 888 |
| foge.dov@gmail.com |
Study information
| Study design | Single-centre unblinded single arm interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| 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 |
| Study objectives | 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(s) | Helsinki committee of Maccabi Health Services, 21/08/2008, ref: 20080395 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/02/2008 |
| Completion date | 01/02/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Minimum required sample size of 90. |
| Total final enrolment | 119 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2008 |
| Date of final enrolment | 01/12/2009 |
Locations
Countries of recruitment
- Israel
Study participating centre
Givat Shmuel
Tel Aviv
54017
Israel
Sponsor information
Hospital/treatment centre
27 HaMered Street
Tel Aviv
6812509
Israel
| Website | http://www.maccabi4u.co.il |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | 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) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 30/04/2018 | 11/07/2023 | Yes | No |
Editorial Notes
11/07/2023: Publication reference and total final enrolment added.
