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

Diabetes Mellitus Clinical Trial

— Phase-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03884920
• Other study ID #: Hashmi5767
• Status: Completed
• Start date: March 20, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: February 2022
• Source: Islamia University of Bahawalpur
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 30, 2021
• Est. primary completion date: May 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Pre Diabetes
• Prediabetic State

Intervention

Dietary Supplement:
• Polyherbal formulation
Test candidate will be administered per oral before / with meal in two divided doses

Locations

Country	Name	City	State
Pakistan	University College of Conventional Medicine	Bahawalpur
Pakistan	Hashmi Dawakhana	Khairpur Tamewali	Punjab

Sponsors (2)

Lead Sponsor	Collaborator
Islamia University of Bahawalpur	Hashmi Herbal Pharma (HHP) Registered Bahawalpur

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Liver Functions	Serum Glutamate pyruvate transaminase (SGPT) (mg/dl)	six week
Other	Liver Function	serum glutamate oxaloacetate transaminase (SGOT)(mg/dl)	six week
Other	Liver Function	Alkaline phosphatase (ALP)	six week
Other	Kidney Function	Serum creatinine (mg/dl)	six week
Other	Kidney Function	Blood Urea Nitrogen (mg/dl)	six week
Primary	Fasting Glucose Tolerance (FGT)	enhancement of fasting glucose tolerance (<100mg/dl)	six weeks
Primary	Glucose Tolerance (GT)	enhancement of oral glucose tolerance (<140mg/dl)	six weeks
Primary	HB-A1c	improvement in glycated hemoglobin (HB-A1c) percentage <6%,	six week
Secondary	Lipid Profile	serum Cholesterol level (mg/dl)	six weeks
Secondary	Lipid Profile	Serum Triglycerides (mg/dl)	Six Weeks
Secondary	Lipid Profile	Serum Low Density Lipids (LDL) (mg/dl)	Six week
Secondary	Lipid Profile	Serum High Density Lipids (HDL) (mg/dl)	six week