Preclinical & Clinical evaluation Of Safety And Efficacy Of Mehmudgar Vati In The Management Of Madhumeha With Special reference To type 2 diabetes mellitus
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Changes in the objective parameters- F.B.S., P.P.B.S. HbA1c from
Study Overview
Brief Summary
AIM
To evaluate the efficacy of Mehmudgara vati in Diabetes mellitus w.s.r to
Madhumeha
OBJECTIVES:
- Pre-clinical Study:
a. To evaluate the safety and efficacy of Mehmudgara Vati in Alloxan induced diabetes
mellitus in wistar albino rats.
b. To assess the effect of Mehmudgara Vati in beta cells (Islets of Langerhans) of
Pancreas through histopathological examination of the pancreatic cells in Alloxan
induced diabetes mellitus in wistar albino rats.
- Clinical Trial:
45
Primary Objectives:
- To evaluate and compare the effect of Mehmudgar Vati on blood glucose level
(FBS, PPBS) and HbA1c in Type -2 Diabetes Mellitus (Madhumeha) patients.
Secondary Objectives:
- To evaluate the effect of Mehmudgara vati on symptoms of Type -2 Diabetes
Mellitus (Madhumeha).
HYPOTHESIS:
ï‚· Null Hypothesis (Ho): There is no difference between effect of Mehmudgar Vati and
Metformin in the management of Madhumeha w.s.r. to Type -2 Diabetes Mellitus.
ï‚· Alternative Hypothesis (HA): There is difference between effect of Mehmudgar Vati
and Metformin in the management of Madhumeha w.s.r. to Type -2 Diabetes Mellitus.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 30.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient ready to give consent for trial and willing to participate in the study
- •Patients between the age group of 30-60 years in either sex.
- •Patients with Fasting Blood Sugar (FBS) in the range of 126mg/dl – 200mg/dl or/and Post Prandial Blood Sugar (PPBS) in the range of 200mg/dl – 250 mg/dl.
- •Presence of Cardinal symptoms of Diabetes Mellitus eg.
- •(3P- polyuria, polydipsia, polyphagia).
Exclusion Criteria
- •Patient not willing to sign the consent form.
- •Patients having Type-1 Diabetes Mellitus.
- •Patients of Type -2 Diabetes Mellitus who are on insulin therapy and Drug induced Diabetes Mellitus.
- •DM with complications and Madhumeha with asadhya upadrava.
- •Patients having any serious illness like cardiovascular diseases, renal diseases, hepatic diseases, acute/ chronic pancreatitis, malignancy, any other endocrinopathies .
- •Pregnant and lactating mother.
- •Patient on any other medications which may interfere with the effect of intervention.
Outcomes
Primary Outcomes
Changes in the objective parameters- F.B.S., P.P.B.S. HbA1c from
Time Frame: 18 weeks
baseline value.
Time Frame: 18 weeks
Secondary Outcomes
- Changes in the clinical symptoms of Mahdumeha (Type 2 diabetes(mellitus))
Investigators
Babulal
National Institute of Ayurveda Deemed to be University, Jaipur