Effects of Mixed Herbs on Blood Glucose and Lipid Profile in T2DM Patients

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Malaysia
Information provided by (Responsible Party):
Dr.Tahir Mahmood, International Islamic University Malaysia
ClinicalTrials.gov Identifier:
NCT02159846
First received: May 22, 2014
Last updated: June 7, 2014
Last verified: June 2014
  Purpose

The aim of this study was to evaluate the effects of mixed herbs as ad-on therapy on blood sugar and lipid profile of patients with established T2DM. A total 20 patients were consented and were equally divided into the Control and the Test groups and was fed with the Placebo or mixed herbs 4 g daily for 30 days, respectively. Blood samples were collected before and at the end of the feeding period and analyzed for the parameters namely Fasting Blood Sugar (FBS), 2 hours post prandial (2HPP) Glycosylated Hb (HbA1c) and Lipid Profile. The collected data was analyzed using SPSS Statistical Software version 12.


Condition
Type 2 Diabetes Mellitus

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: The Effects of Mixed Herbs on Blood Glucose and Lipid Profile of Patients With Established Type II Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by International Islamic University Malaysia:

Primary Outcome Measures:
  • Allergy or hypersensitivity to preparation [ Time Frame: within the consumption period (30 days) ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: August 2013
Study Completion Date: October 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Test Group and Control Group
20 patients with established T2DM were recruited from the M-OPD, HTAA, Kuantan; and equally divided into the Test and the Control groups (10 patients in each group).These patients were either fed with 4 g daily mixed herbs (on wet weight basis) or placebo (maize starch).
Test Group & Control Group
20 patients with established T2DM were recruited from the M-OPD, HTAA, Kuantan; and equally divided into the Test and the Control groups (10 patients in each group).These patients were either fed with 4 g daily mixed herbs (on wet weight basis) or placebo (maize starch).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

In the present study, 20 patients with established T2DM were recruited from the M-OPD, HTAA, Kuantan; and equally divided into the control and the test groups (10 patients in each group).These patients were either fed with placebo (maize starch) or 4 g daily mixed herbs (on wet weight basis).

Criteria

Inclusion Criteria:

  • The patients having established T2DM, adult, both sexes were included in the study.

Exclusion Criteria:

  • The patients having T1DM, allergy or intolerant to herbs, consuming other herbal supplements and pregnant women with/without gestational diabetes mellitus (GDM) were excluded from the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02159846

Locations
Malaysia
Medical Out-Patient Department (M-OPD),Hospital Tengku Ampuan Afzan Kuantan.
Kuantan, Pahang, Malaysia, 25200
Sponsors and Collaborators
International Islamic University Malaysia
Ministry of Health, Malaysia
Investigators
Principal Investigator: TAHIR MAHMOOD, M.B;B.S Netherlands: Ministry of Health, Welfare and Sports
  More Information

No publications provided

Responsible Party: Dr.Tahir Mahmood, Postgraduate student for the programme of, International Islamic University Malaysia
ClinicalTrials.gov Identifier: NCT02159846     History of Changes
Other Study ID Numbers: DC14-1287
Study First Received: May 22, 2014
Last Updated: June 7, 2014
Health Authority: Malaysia: Ministry of Health

Keywords provided by International Islamic University Malaysia:
Herbs
Diabetes Mellitus
HbA1c
Lipid Profile

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 22, 2014