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

Sponsor

Islamia University of Bahawalpur (Other)

Overall Status

Completed

CT.gov ID

NCT03884920

Collaborator

Hashmi Herbal Pharma (HHP) Registered Bahawalpur (Other)

Enrollment

Locations

33.4

Actual Duration (Months)

28.5

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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. One year followup of participants was conducted.

Study Design

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 :

Mar 20, 2019

Actual Primary Completion Date :

May 5, 2019

Actual Study Completion Date :

Dec 30, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Lipid Profile [six weeks]
serum Cholesterol level (mg/dl)
Lipid Profile [Six Weeks]
Serum Triglycerides (mg/dl)
Lipid Profile [Six week]
Serum Low Density Lipids (LDL) (mg/dl)
Lipid Profile [six week]
Serum High Density Lipids (HDL) (mg/dl)

Other Outcome Measures

Liver Functions [six week]
Serum Glutamate pyruvate transaminase (SGPT) (mg/dl)
Liver Function [six week]
serum glutamate oxaloacetate transaminase (SGOT)(mg/dl)
Liver Function [six week]
Alkaline phosphatase (ALP)
Kidney Function [six week]
Serum creatinine (mg/dl)
Kidney Function [six week]
Blood Urea Nitrogen (mg/dl)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 59 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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