Diabetes MellitusPhase-1NCT03884920
Glucose Tolerance and Prevention of Diabetes Mellitus Type 2 by Polyherbal Formulation
An observational study of Diabetes Mellitus and Pre Diabetes, run by Islamia University of Bahawalpur at 2 sites in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Pre Diabetes
- What is being tested?
- Polyherbal formulation
- Type of treatment
- Pill or oral medicine
- How many people
- 57 participants
- Where
- 2 sitesPakistan
- Study dates
- 20 Mar 2019to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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)
Who cannot join
- 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);
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- 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
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
University College of Conventional Medicine
Bahawalpur, 63100
Hashmi Dawakhana
Khairpur Tamewali, Punjab Province, 63060
About this study
Official title: Impaired Glucose Tolerance and Prevention of Diabetes Mellitus Type 2 by Polyherbal Formulation of Eastern Medicine
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.
Read the 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
- Being tested
- Polyherbal formulation
- Keywords
- Impaired Fasting Glucose, Impaired Glucose Tolerance, 2hr -75gm Oral Glucose Tolerance Test, Diabetes Mellitus Prevention
- Medical subject headings
- Diabetes Mellitus, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyherbal formulationDietary supplement
Test candidate will be administered per oral before / with meal in two divided doses
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Polyherbal formulation | |
| Group C Diabetic test | Early onset of Diabetes mellitus receiving polyherbal formulation 1800mg in two divided doses for six weeks Receives: Dietary Supplement: Polyherbal formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Glucose Tolerance (FGT)
enhancement of fasting glucose tolerance (<100mg/dl)
Measured: six weeks
Glucose Tolerance (GT)
enhancement of oral glucose tolerance (<140mg/dl)
Measured: six weeks
HB-A1c
improvement in glycated hemoglobin (HB-A1c) percentage <6%,
Measured: six week
Secondary outcomes (4)
Lipid Profile
serum Cholesterol level (mg/dl)
Measured: six weeks
Lipid Profile
Serum Triglycerides (mg/dl)
Measured: Six Weeks
Lipid Profile
Serum Low Density Lipids (LDL) (mg/dl)
Measured: Six week
Lipid Profile
Serum High Density Lipids (HDL) (mg/dl)
Measured: six week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start20 Mar 2019
- Primary completion5 May 2019
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamia University of Bahawalpur
- Sponsor type
- University, hospital or other
- Collaborators
- Hashmi Herbal Pharma (HHP) Registered Bahawalpur
- Responsible party
- Principal investigator, Hafiz Abdul Sattar Hashmi, Islamia University of Bahawalpur
- Investigators
- H A Sattar Hashmi, M.Phil, Principal investigator, scholarDr K A.Ansari, Ph.D, Study director, AP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884920
- Sponsor's protocol ID
- Hashmi5767
- Acronym
- Phase-1
- Status last verified
- Feb 2022
- First submitted
- 15 Mar 2019
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impaired Glucose Tolerance and Prevention of Diabetes Mellitus Type 2 by Polyherbal Formulation of Eastern Medicine
- ClinicalTrials.gov ID
- NCT03884920
- Acronym / sponsor ID
- Phase-1 / Hashmi5767
- Conditions
- Diabetes Mellitus, Pre Diabetes
- Keywords
- Impaired Fasting Glucose, Impaired Glucose Tolerance, 2hr -75gm Oral Glucose Tolerance Test, Diabetes Mellitus Prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Islamia University of BahawalpurUniversity, hospital or other
- Collaborators
- Hashmi Herbal Pharma (HHP) Registered Bahawalpur
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 5 May 2019 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A Pre-diabetic placebo | – | –Group of pre-diabetics receiving placebo BD for six weeks |
| Group B Pre-diabetic test | – | Dietary Supplement: Polyherbal formulationGroup of Pre-diabetic receiving polyherbal / test candidate 900mg in two divided doses for six weeks |
| Group C Diabetic test | – | Dietary Supplement: Polyherbal formulationEarly onset of Diabetes mellitus receiving polyherbal formulation 1800mg in two divided doses for six weeks |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (6 listed)
- 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%
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyherbal formulationTest candidate will be administered per oral before / with meal in two divided doses | Dietary supplement | Group B Pre-diabetic test, Group C Diabetic test |
Primary outcome
Fasting Glucose Tolerance (FGT)
Time frame: six weeks
enhancement of fasting glucose tolerance (<100mg/dl)
Glucose Tolerance (GT)
Time frame: six weeks
enhancement of oral glucose tolerance (<140mg/dl)
HB-A1c
Time frame: six week
improvement in glycated hemoglobin (HB-A1c) percentage <6%,
4 secondary outcomes
Lipid Profile
Time frame: six weeks
Lipid Profile
Time frame: Six Weeks
Lipid Profile
Time frame: Six week
Lipid Profile
Time frame: six week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H A Sattar Hashmi, M.Phil principal investigator
scholar
Dr K A.Ansari, Ph.D study director
AP
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Pre Diabetes, run by Islamia University of Bahawalpur at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting Glucose Tolerance (FGT) (time frame: six weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.