None listed
Conditions
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.
Interventions
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
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.
Sponsors
Malik Hassan Mehmood
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Type-2 diabetes mellitus
Exclusion criteria
Juvenile Type Diabetes Pregnancy Dementia Diabetes complicated by diabetic foot or other cardiovascular conditions.
Outcome results
None listed