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

Completed

• Conditions: Diabetes Mellitus; Pre Diabetes
• Interventions: Dietary Supplement: Polyherbal formulation

• Registration Number: NCT03884920
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-03-19
• Study Start: 2019-03-20
• Study First Posted: 2019-03-21
• Primary Completion: 2019-05-05
• Study Completion: 2021-12-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-19
• Last Update Posted: 2022-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group B Pre-diabetic test	Polyherbal formulation	Group of Pre-diabetic receiving polyherbal / test candidate 900mg in two divided doses for six weeks
Group C Diabetic test	Polyherbal formulation	Early onset of Diabetes mellitus receiving polyherbal formulation 1800mg in two divided doses for six weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Lipid Profile	six week	Serum High Density Lipids (HDL) (mg/dl)

Trial Locations

Locations (2)

Hashmi Dawakhana; 🇵🇰 Khairpur Tamewali, Punjab, Pakistan

University College of Conventional Medicine; 🇵🇰 Bahawalpur, Pakistan