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

NCT ID: NCT03884920

Last Updated: 2022-02-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 57 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-20
• Study Completion Date: 2021-12-30

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.

Conditions

Diabetes Mellitus; Pre Diabetes

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Group A Pre-diabetic placebo

Group of pre-diabetics receiving placebo BD for six weeks

No interventions assigned to this group

Group B Pre-diabetic test

Group of Pre-diabetic receiving polyherbal / test candidate 900mg in two divided doses for six weeks

Polyherbal formulation

Intervention Type: DIETARY_SUPPLEMENT

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

Polyherbal formulation

Intervention Type: DIETARY_SUPPLEMENT

Test candidate will be administered per oral before / with meal in two divided doses

Interventions

Polyherbal formulation

Test candidate will be administered per oral before / with meal in two divided doses

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hashmi Herbal Pharma (HHP) Registered Bahawalpur

UNKNOWN

Sponsor Role: collaborator

Islamia University of Bahawalpur

OTHER

Sponsor Role: lead

Responsible Party

Hafiz Abdul Sattar Hashmi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

H A Sattar Hashmi, M.Phil

Role: PRINCIPAL_INVESTIGATOR

scholar

Dr K A.Ansari, Ph.D

Role: STUDY_DIRECTOR

AP

Locations

Hashmi Dawakhana

Khairpur Tamewali, Punjab Province, Pakistan

University College of Conventional Medicine

Bahawalpur, , Pakistan

Countries

Pakistan

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

Hashmi5767

Identifier Type: -

Identifier Source: org_study_id