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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03884920
Other study ID # Hashmi5767
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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