Comparative clinical study of yava and yavaka based pathya ahara kalpana in the management of madhumeha W.S.R. to Diabetes mellitus type 2.
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Changes in the objective parameters-F.B.S.,P.P.B.S., Urine - Routine and Microscopic examination, Lipid Profile, LFT, RFT from baseline value.
Study Overview
Brief Summary
Madhumeh is controlled by regular and proper diet followed by proper medicines in ayurveda and various aahar preparations are mentioned as pathya in which and yavaka pathya ahara kalpana are one among them.various studies have been undertaken to observe the efficacy of yava and yavaka indidivually but studies to compare the clinical efficacy between yavakaand yava on madhumeha has not been done yet.
AIM : To compare the efficacy two groups i.e yava and yavaka ahara kalpana in the management of madhumeh.
*OBJECTIVE:*To conduct randomized clinical trial in order to evalute the efficacy of Yava(Hordeum vulgare linn.) and Yavaka ( Avena sativa linn.) in madhumeha
Null hypothesis (H0): There is no difference between yava and yavaka ahara kalpana in two groups of madhumeha patients.
Alternate hypothesis (H1): There is difference between yava and yavaka ahara kalpanain two groups of madhumeha patients.
Study design: Study type- Prospective, randomized, two arm clinical trial, Phase of clinical trial- Phase – 2, Number of groups- Two, Number of patients - 60, Duration : 18 months
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 30.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with Fasting Blood Sugar (FBS) in the range of 126-180 mg/dl, Post Prandial Blood Sugar (PPBS) in the range of 140 – 250 mg/dl.
- •Type 2 Diabetes Mellitus Presence of cardinal symptoms of Madhumeha as described in Ayurvedic texts.
Exclusion Criteria
- •Patients of Type 1 Diabetes.
- •Patients of Type 2 Diabetes who are on insulin therapy.
- •Patients having any serious illness like coronary artery disease, malignancy, kidney failure, neuropathy etc.Pregnant women and lactating mother.
Outcomes
Primary Outcomes
Changes in the objective parameters-F.B.S.,P.P.B.S., Urine - Routine and Microscopic examination, Lipid Profile, LFT, RFT from baseline value.
Time Frame: 4 weeks
Secondary Outcomes
- Changes in the clinical symptoms of Mahdumeha((Type 2 diabetes mellitus))
Investigators
Jyoti khinchi
National institute of Ayurveda