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

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ClinicalTrials.gov Identifier: NCT02159846
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : June 10, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Type 2 Diabetes Mellitus

  Show Detailed Description

Study Design

Study Type : Observational [Patient Registry]
Actual Enrollment : 20 participants
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
Study Start Date : August 2013
Primary Completion Date : September 2013
Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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).


Outcome Measures

Primary Outcome Measures :
  1. Allergy or hypersensitivity to preparation [ Time Frame: within the consumption period (30 days) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: June 10, 2014
Last Verified: June 2014

Keywords provided by Dr.Tahir Mahmood, International Islamic University Malaysia:
Herbs
Diabetes Mellitus
HbA1c
Lipid Profile

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