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

Impaired Glucose Tolerance and Prevention of Diabetes Mellitus Type 2 by Polyherbal Formulation of Eastern Medicine

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Pre Diabetes
• Intervention / Treatment: 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. One year followup of participants was conducted.

• Study Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

Study Locations

• Pakistan
  • Bahawalpur, Pakistan, 63100
    • University College of Conventional Medicine
  • Punjab
    • Khairpur Tamewali, Punjab, Pakistan, 63060
      • Hashmi Dawakhana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting Glucose Tolerance (FGT)	enhancement of fasting glucose tolerance (<100mg/dl)	six weeks
Glucose Tolerance (GT)	enhancement of oral glucose tolerance (<140mg/dl)	six weeks
HB-A1c	improvement in glycated hemoglobin (HB-A1c) percentage <6%,	six week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid Profile	serum Cholesterol level (mg/dl)	six weeks
Lipid Profile	Serum Triglycerides (mg/dl)	Six Weeks
Lipid Profile	Serum Low Density Lipids (LDL) (mg/dl)	Six week
Lipid Profile	Serum High Density Lipids (HDL) (mg/dl)	six week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver Functions	Serum Glutamate pyruvate transaminase (SGPT) (mg/dl)	six week
Liver Function	serum glutamate oxaloacetate transaminase (SGOT)(mg/dl)	six week
Liver Function	Alkaline phosphatase (ALP)	six week
Kidney Function	Serum creatinine (mg/dl)	six week
Kidney Function	Blood Urea Nitrogen (mg/dl)	six week

Collaborators and Investigators

• Sponsor: Islamia University of Bahawalpur
• Collaborators: Hashmi Herbal Pharma (HHP) Registered Bahawalpur
• Investigators: Principal Investigator: H A Sattar Hashmi, M.Phil, scholar; Study Director: Dr K A.Ansari, Ph.D, AP

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2019
• Primary Completion (Actual): May 5, 2019
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: March 15, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 19, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Impaired Fasting Glucose; Impaired Glucose Tolerance; 2hr -75gm Oral Glucose Tolerance Test; Diabetes Mellitus Prevention
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State
• Other Study ID Numbers: Hashmi5767

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No