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

Not Applicable

Completed

• Conditions: Type 2 diabetes mellitus; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN12562776
• Lead Sponsor: Maccabi Healthcare Services

Brief Summary

2018 Results article in https://pubmed.ncbi.nlm.nih.gov/30271713/ (added 11/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2010-02-01
• Study Start: 2017-06-12
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 119

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1. Fasting blood glucose is assessed by laboratory blood glucose test at baseline nd thereafter weekly up to week 12<br>2. Blood total cholesterol and triglyceride levels are assessed by laboratory lipid profile blood test at pre-enrolment (week -2), 6 and 12 weeks<br>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)