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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12562776

Enrollment

Registered

2017-06-12

Start date

2008-09-01

Completion date

Unknown

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus

Interventions

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 mealt

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Israel

Contacts

Public ContactDov Fogel

foge.dov@gmail.com+972 35 325 888

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026