A Randomized open labelled controlled clinical study to evaluate the efficacy of Avipattikara churna in prameha with special reference to Type 2 Diabetes Mellitus.
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Significant decrease in Blood Sugar levels assessed based on Fasting Blood Sugar and Post Prandial Blood Sugar.
Study Overview
Brief Summary
Diabetes mellitus is a metabolic non communicable disease, one of the most serious health challenges worldwide adding to the economical burden.
It is characterized by chronic hyperglycemia resulting from reduced insulin secretion, decreased glucose utilization and increased glucose production. American diabetes association has classified diabetes mellitus into type-1, type-2 and Gestational diabetes mellitus. As per IDF. In 2021 537 million people had Diabetes Mellitus which is expected to rise to 643 million by 2030 and 783 million by 2045. Men having slightly higher rates than women. According to IDF, incidence of Diabetes Mellitus in India was 9.6% in 2021 which is expected to rise to 10.9% by 2045.
According to WHO in 2019, diabetes mellitus accounted for 1.6 million deaths becoming the 9th leading cause of death. Based on the presentation and pathogenesis of type 2 diabetes mellitus, the disease can be understood as Prameha, a Santarpanottha vikara, characterized with excessive urination (both in frequency and quantity) and change in appearance. According to contemporary science along with oral hypoglycemic agents, diet and lifestyle modification is stressed upon. Currently, various anti diabetic drugs in contemporary medicine are used for controlling diabetes which is lifelong requirement in general. But their long applications cause adverse drug reactions including gastro intestinal disturbances, renal and hepatic impairment. In Ayurveda, various drugs are used to treat Diabetes Mellitus.
As Ayurvedic medications show a better management in improving symptoms, there is a need to search a effective medication for diabetes mellitus over synthetic /chemical preparations*.* Avipattikara churna mentioned in Bhaishajya ratnavali in the context of Amlapittadhikara is attributed to be having property for management of vimshathi prameha. Hence, considering the above background, it is thought worthy to evaluate the efficacy of Avipattikara churna in the management of prameha with special reference to Type 2 Diabetes Mellitus. Nishaamalaki churna is a proven and commonly used drug for management of Diabetes Mellitus considering that it is taken as a control drug for the present study.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 30.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Subjects diagnosed with Diabetes Mellitus having HbA1C within range of 6.5% to 8%.
- •2.Subjects between the age group of 30 to 60 years irrespective of gender.
- •3.Subjects willing to participate with written informed consent, which is conveyed in the language, which the subject can understand.
Exclusion Criteria
- •1.Subjects diagnosed with Type1 Diabetes Mellitus.
- •2.Subjects who are on any intervention for Diabetes Mellitus.
- •3.Pregnant and Lactating women.
- •4.Subjects with diseases which may interfere with disease or course of treatment.
Outcomes
Primary Outcomes
Significant decrease in Blood Sugar levels assessed based on Fasting Blood Sugar and Post Prandial Blood Sugar.
Time Frame: before intervention - 0th day | After intervention - 30th day | Follow up - 45th day
Secondary Outcomes
- To improve the quality of life.(Generation of in depth analysed data on the)
Investigators
Dr Vandita M
Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore