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Trial registered on ANZCTR


Registration number
ACTRN12619001626156
Ethics application status
Approved
Date submitted
13/07/2019
Date registered
25/11/2019
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of condiment herbal tea on type-2 diabetes patients in Pakistan.
Scientific title
Effect of condiment herbal tea on hyperlipidemia and hyperglycemia for patients with type-2 diabetes mellitus: A randomized controlled trial.
Secondary ID [1] 298730 0
None
Universal Trial Number (UTN)
U1111-1236-9570
Trial acronym
HTIOHAH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperglycemia 313656 0
Hyperlipidemia 313657 0
Condition category
Condition code
Alternative and Complementary Medicine 312072 312072 0 0
Herbal remedies
Diet and Nutrition 312073 312073 0 0
Obesity
Metabolic and Endocrine 312074 312074 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study, about 110 patients shall be screened who are diagnosed with Type-2 diabetes mellitus. The patients shall be allocated into control and intervention group by block randomization method while the demographics and other lab parameters shall be co-variates for randomization. The initial data (at 0) shall be recorded on prestructured data collection form. The control group will not receive any type of intervention whereas the intervention group patients will be provided with herbal tea for once daily use for about 90 days. After taking tea for 90 day, data post-intervention data will be recorded.
The tea bags will be given patients. The tea bag will be put in a cup (250ml) containing boiling or briskly hot water for 5 minutes. After discarding the tea bag, patient will keep tea tag and will drink the tea. The frequency for taking this tea is one cup of tea per day for about 90 days.
Each tea bag consist of granule sized particle of fennel, cardamom, dried ginger, and lemon grass. Each tea bags weighs 0.5g +/- 0.05g.
To assess the adherence to intervention, the patient shall be asked to return tea tags for used tea bags and unused tea bags at the end of month where adherence shall be calculated on percentage basis.
Intervention code [1] 314991 0
Treatment: Other
Comparator / control treatment
Control group will not receive any type of intervention or the herbal tea.
Control group
Active

Outcomes
Primary outcome [1] 320705 0
HbA1C
by Serum assay
Timepoint [1] 320705 0
90 days post-treatment
Primary outcome [2] 320706 0
Lipid Profile (High Density Lipoproteins, Low density Lipoproteins, Triglycerides, Cholesterol)
by serum assay
Timepoint [2] 320706 0
90 days post-treatment
Primary outcome [3] 320707 0
Blood Glucose Level
by use of Glucometers
Timepoint [3] 320707 0
90 days post-treatment
Secondary outcome [1] 372579 0
Total body fats
by use of Fat analyzer machine (Omron BF508)
Timepoint [1] 372579 0
90 days post treatment
Secondary outcome [2] 372580 0
Blood pressure
by automated machine
Timepoint [2] 372580 0
90 days post treatment
Secondary outcome [3] 375061 0
Body Mass Index
by use of Fat analyzer machine (Omron BF 508)
Timepoint [3] 375061 0
90 days post treatment

Eligibility
Key inclusion criteria
Type-2 diabetes mellitus
Minimum age
30 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Juvenile Type Diabetes
Pregnancy
Dementia
Diabetes complicated by diabetic foot or other cardiovascular conditions.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be done by means of Block Randomization method.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization method
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
23/09/2019
Date of last participant enrolment
Anticipated
Actual
30/09/2019
Date of last data collection
Anticipated
2/01/2020
Actual
Sample size
Target
110
Accrual to date
Final
110
Recruitment outside Australia
Country [1] 21682 0
Pakistan
State/province [1] 21682 0
Punjab

Funding & Sponsors
Funding source category [1] 303283 0
Government body
Name [1] 303283 0
Higher Education Commission of Pakistan
Country [1] 303283 0
Pakistan
Primary sponsor type
Individual
Name
Malik Hassan Mehmood
Address
Department of Pharmacology, Faculty of Pharmaceutical Sciences, Government College University, Kotwali Road, Gurunanakpura, Faisalabad-38000, Punjab
Country
Pakistan
Secondary sponsor category [1] 303302 0
Individual
Name [1] 303302 0
Tauqeer Hussain Mallhi
Address [1] 303302 0
Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Government College University, Kotwali Road, Gurunanakpura, Faisalabad-38000, Punjab
Country [1] 303302 0
Pakistan
Other collaborator category [1] 280850 0
Individual
Name [1] 280850 0
Mustafa Ijaz
Address [1] 280850 0
Faculty of Pharmaceutical Sciences, Government College University, Kotwali Road, Gurunanakpura, Faisalabad-38000, Punjab
Country [1] 280850 0
Pakistan
Other collaborator category [2] 280852 0
Individual
Name [2] 280852 0
Zulqarnain Haider
Address [2] 280852 0
Department of Pharmacology, Faculty of Pharmaceutical Sciences, Government College University, Kotwali Road, Gurunanakpura, Faisalabad-38000, Punjab
Country [2] 280852 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303820 0
Institutional Ethical Committee of Government College University Faisalabad
Ethics committee address [1] 303820 0
Government College University,
Allama Iqbal Road,
Faisalabad city-38000, Punjab, Pakistan
Ethics committee country [1] 303820 0
Pakistan
Date submitted for ethics approval [1] 303820 0
31/07/2019
Approval date [1] 303820 0
01/08/2019
Ethics approval number [1] 303820 0
GCUF/ERC/2064

Summary
Brief summary
Hypothesis, Aim and Objective: Diabetes and hypercholestrolemia are becoming the increasing factors for increased morbidity and mortality in all over world. Diabetes is becoming uncontrollable due to lack of awareness and knowledge and is causing co-morbidities like cardiovascular diseases, cerebrovascular diseases etc. To control diabetes, a herbal of special composition is to be introduced.

Study design: The study is designed as prospective randomized controlled trial. The time period between pre- and post-intervention data collection is 90 days. Consents will be taken from patients prior to starting of trial. Trial will be multicenter. Around 110 patients will be screened and they shall be allocated to either intervention or control group by block randomization method. Intervention includes once daily use of herbal tea (will be provided as tea bags made according to international guidelines).
The outcomes will be assessed by primary parameters Lipid profile, glucose profile and secondary parameters weight, BMI, visceral fats, total body fats.
Trial website
.
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94922 0
A/Prof Malik Hassan Mehmood
Address 94922 0
Department of Pharmacology, Faculty of Pharmaceutical Sciences, Government College University, Faisalabad-38000, Punjab
Country 94922 0
Pakistan
Phone 94922 0
+92419201036
Fax 94922 0
Email 94922 0
malikhassan.mehmood@googlemail.com
Contact person for public queries
Name 94923 0
Mustafa Ijaz
Address 94923 0
Faculty of Pharmaceutical Sciences, Government College University, Faisalabad-38000, Punjab
Country 94923 0
Pakistan
Phone 94923 0
+923357393376
Fax 94923 0
Email 94923 0
mustafaijaz78@gmail.com
Contact person for scientific queries
Name 94924 0
Tauqeer Hussain Mallhi
Address 94924 0
Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Government College University, Faisalabad-38000, Punjab
Country 94924 0
Pakistan
Phone 94924 0
+923007600072
Fax 94924 0
Email 94924 0
tauqeer.hussain.mallhi@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data except the name and other identification numbers.
When will data be available (start and end dates)?
9/23/2019-9/23/2021
Available to whom?
Only to researchers.
To appropriate applicable at the discretion of principal investigator or primary sponsor.
Available for what types of analyses?
any purpose
How or where can data be obtained?
By writing an application and email to principal investigator / primary sponsor.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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