NCT03884920

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

March 20, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2019

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

February 22, 2022

Status Verified

February 1, 2022

Enrollment Period

2 months

First QC Date

March 15, 2019

Last Update Submit

February 19, 2022

Conditions

Diabetes MellitusPre Diabetes

Keywords

Impaired Fasting GlucoseImpaired Glucose Tolerance2hr -75gm Oral Glucose Tolerance TestDiabetes Mellitus Prevention

Outcome Measures

Primary Outcomes (3)

  • Fasting Glucose Tolerance (FGT)

    enhancement of fasting glucose tolerance (\<100mg/dl)

    six weeks

  • Glucose Tolerance (GT)

    enhancement of oral glucose tolerance (\<140mg/dl)

    six weeks

  • HB-A1c

    improvement in glycated hemoglobin (HB-A1c) percentage \<6%,

    six week

Secondary Outcomes (4)

  • Lipid Profile

    six weeks

  • Lipid Profile

    Six Weeks

  • Lipid Profile

    Six week

  • Lipid Profile

    six week

Other Outcomes (5)

  • Liver Functions

    six week

  • Liver Function

    six week

  • Liver Function

    six week

  • +2 more other outcomes

Study Arms (3)

Group A Pre-diabetic placebo

Group of pre-diabetics receiving placebo BD for six weeks

Group B Pre-diabetic test

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

Dietary Supplement: Polyherbal formulation

Group C Diabetic test

Early onset of Diabetes mellitus receiving polyherbal formulation 1800mg in two divided doses for six weeks

Dietary Supplement: Polyherbal formulation

Interventions

Polyherbal formulationDIETARY_SUPPLEMENT

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

Group B Pre-diabetic testGroup C Diabetic test

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

* community samples will be obtained from the area of Bahawalpur * Model Town A, B, and * remote areas of district Bahawalpur consisting of Khairpur Tamewali city population

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hashmi Dawakhana

Khairpur Tamewali, Punjab Province, 63060, Pakistan

Location

University College of Conventional Medicine

Bahawalpur, 63100, Pakistan

Location

MeSH Terms

Conditions

Diabetes MellitusGlucose Intolerance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemia

Study Officials

  • H A Sattar Hashmi, M.Phil

    scholar

    PRINCIPAL INVESTIGATOR

  • Dr K A.Ansari, Ph.D

    AP

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 15, 2019

First Posted

March 21, 2019

Study Start

March 20, 2019

Primary Completion

May 5, 2019

Study Completion

December 30, 2021

Last Updated

February 22, 2022

Record last verified: 2022-02

Locations

PA(2)