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Effective Enhancement of Glucose Tolerance and Prevention of Diabetes Mellitus Type 2 by Polyherbal Formulation (Phase-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884920
Recruitment Status : Completed
First Posted : March 21, 2019
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Hafiz Abdul Sattar Hashmi, Islamia University of Bahawalpur

Brief Summary:
Primary protocol to this study is to develop a natural remedy to prevent diabetes mellitus in pre-diabetic state and elaborate the effectiveness of polyherbal formulation for carrying out Phase-II, III and IV. It also aimed at to see the level of difference of glucose tolerance and impaired fasting glucose and impaired glucose tolerance between pre-diabetic and diabetic to evaluate the potential benefit for treatment of insulin resistance and sensitivity. To see the for prevention of Diabetes Mellitus (DM) and stopping / delaying the onset of DM.

Condition or disease Intervention/treatment
Diabetes Mellitus Pre Diabetes Dietary Supplement: Polyherbal formulation

Detailed Description:

This study is a clinical trial study to evaluate the potential of prevention in pre-diabetics and to prevent onset of diabetes mellitus. For this purpose, volunteers will be enrolled in the study by observing the Helsinki Declaration for clinical trials.

volunteers will be screened for the impaired glucose tolerance or impaired fasting glucose or at risk to develop diabetes mellitus type 2.

On screening, pre-diabetics and early onset diabetics with no previous history of treatment etc will be grouped into A and B.

Biochemical evaluations will be carried out at base line and followed by three weeks intervention and evaluation of biomarkers and at sixth week for further evaluation.

Collected data will be evaluated for primary out comes and secondary out come. statistical analysis will be done.

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Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Impaired Glucose Tolerance and Prevention of Diabetes Mellitus Type 2 by Polyherbal Formulation of Eastern Medicine
Actual Study Start Date : March 20, 2019
Actual Primary Completion Date : May 5, 2019
Actual Study Completion Date : May 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Group/Cohort Intervention/treatment
Group A Pre-diabetic placebo
Group of pre-diabetics receiving placebo BD for six weeks
Group B Pre-diabetic test
Group of Pre-diabetic receiving polyherbal / test candidate 900mg in two divided doses for six weeks
Dietary Supplement: Polyherbal formulation
Test candidate will be administered per oral before / with meal in two divided doses

Group C Diabetic test
Early onset of Diabetes mellitus receiving polyherbal formulation 1800mg in two divided doses for six weeks
Dietary Supplement: Polyherbal formulation
Test candidate will be administered per oral before / with meal in two divided doses




Primary Outcome Measures :
  1. Fasting Glucose Tolerance (FGT) [ Time Frame: six weeks ]
    enhancement of fasting glucose tolerance (<100mg/dl)

  2. Glucose Tolerance (GT) [ Time Frame: six weeks ]
    enhancement of oral glucose tolerance (<140mg/dl)

  3. HB-A1c [ Time Frame: six week ]
    improvement in glycated hemoglobin (HB-A1c) percentage <6%,


Secondary Outcome Measures :
  1. Lipid Profile [ Time Frame: six weeks ]
    serum Cholesterol level (mg/dl)

  2. Lipid Profile [ Time Frame: Six Weeks ]
    Serum Triglycerides (mg/dl)

  3. Lipid Profile [ Time Frame: Six week ]
    Serum Low Density Lipids (LDL) (mg/dl)

  4. Lipid Profile [ Time Frame: six week ]
    Serum High Density Lipids (HDL) (mg/dl)


Other Outcome Measures:
  1. Liver Functions [ Time Frame: six week ]
    Serum Glutamate pyruvate transaminase (SGPT) (mg/dl)

  2. Liver Function [ Time Frame: six week ]
    serum glutamate oxaloacetate transaminase (SGOT)(mg/dl)

  3. Liver Function [ Time Frame: six week ]
    Alkaline phosphatase (ALP)

  4. Kidney Function [ Time Frame: six week ]
    Serum creatinine (mg/dl)

  5. Kidney Function [ Time Frame: six week ]
    Blood Urea Nitrogen (mg/dl)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  • community samples will be obtained from the area of Bahawalpur
  • Model Town A, B, and
  • remote areas of district Bahawalpur consisting of Khairpur Tamewali city population
Criteria

Inclusion Criteria:

  • Age: 18-59
  • Impaired Fasting Glucose (100-125mg/dl)
  • Impaired Glucose Tolerance (140-199mg/dl) 2h-75gm OGTT
  • History of Diabetes in first degree relation with one condition
  • At high risk with BMI > 35%
  • Early onset diabetic / accidental on screening (glucose >200mg/dl)

Exclusion Criteria:

  • on renal dialysis;
  • an acute or terminal illness or serious mental illness;
  • history of recent coronary event within the last 12 months;
  • a recent history of acute medical problem or admission to hospital;
  • any other severe medical conditions that need intervention / treatment
  • has poor short-term prognosis (expected death in <2 years);
  • is planning to travel for longer than 6 weeks during the 6-week intervention period; or
  • is with compromised liver / kidney / cardiac function
  • older patients of DM taking any form of medication / intervention

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): NCT03884920


Locations
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Pakistan
University College of Conventional Medicine
Bahawalpur, Pakistan, 63100
Sponsors and Collaborators
Islamia University of Bahawalpur
Investigators
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Principal Investigator: H A Sattar Hashmi, M.Phil scholar
Study Director: Dr K A.Ansari, Ph.D AP
  Study Documents (Full-Text)

Documents provided by Hafiz Abdul Sattar Hashmi, Islamia University of Bahawalpur:
Study Protocol  [PDF] March 20, 2019

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Responsible Party: Hafiz Abdul Sattar Hashmi, Principal Investigator, Islamia University of Bahawalpur
ClinicalTrials.gov Identifier: NCT03884920    
Other Study ID Numbers: Hashmi5767
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hafiz Abdul Sattar Hashmi, Islamia University of Bahawalpur:
Impaired Fasting Glucose
Impaired Glucose Tolerance
2hr -75gm Oral Glucose Tolerance Test
Diabetes Mellitus Prevention
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases