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

Islamia University of Bahawalpur

Status

Completed

Conditions

Diabetes Mellitus

Pre Diabetes

Treatments

Dietary Supplement: Polyherbal formulation

Study type

Observational

Funder types

Other

Identifiers

NCT03884920

Hashmi5767

Details and patient eligibility

About

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.

Full 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.

Enrollment

57 patients

Sex

All

Ages

18 to 59 years old

Volunteers

Accepts Healthy Volunteers

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