A Prospective, open labelled, single arm, non randomized, single centric, phase II, Clinical trail to determine the effectiveness of Pathiriver chooranam in the management of Madhumega Noi(Diabetes mellitus)
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Government Siddha medical college and Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- The outcome will be aimed at reducing symptoms of Diabetes mellitus and to determine the therapeutic efficacy of Pathiriver chooranam
Overview
Brief Summary
This is A Prospective, open labelled, single arm,non randomized, single centric, phase II, Clinical trail to determine the effectiveness of Pathiriver chooranam in the management of Madhumega Noi( DiabetesMellitus). Pathiri ver chooranam will be freshly prepared and administered at a dosage of 1 to 2 gms (Twice a day orally) with hot water as adjuvant for 3 months for 40 patients of Diabetes mellitus ( 20 OP AND 20 IP patients). The primary outcome will be to develop evidence support for the effect of Pathiriver chooranam in the management of Madhumegam (Diabetes Mellitus ). The secondary outcome will be to collect various siddha literatures and modern journals, to evaluate Physio Chemical, Phyto Chemical, Bio Chemical analysis, to study the anti-microbial activity for selected micro-organism, to evaluate Pharmacological activities, to evaluate safety profile for acute and sub-acute toxicity, to evaluate modern parametric changes in Madhumegam, to evaluate the cell line study of anti-diabetic activity, to evaluate siddha parameters and compare the changes in Madhumegam during trial period.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 35.00 Year(s) to 59.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Even if patient is having any one among the three (WHO criteria 2019): a.
- •FBS above 126 mg/dl and below 250mg/dl or b.
- •PPBS above 200mg/dl and below 350mg /dl or c.
- •HbA1c above 6.5 and below 10
- •Patients with symptoms of polyuria, polydipsia , polyphagia, asthenia, nocturia,obesity ( metabolic syndrome) , numbness, tingling sensation, mood changes and irritability, difficulty in concentration.
Exclusion Criteria
- •1.Age below above 34 years and below 60 years 2.Type 1 diabetes mellitus 3.Gestational DM 4.Diabetes insipidus 5.Pregnancy 6.Lactating mother 7.Chronic kidney disease 8.Chronic lever disease 9.Ischemic heart diseases.
Outcomes
Primary Outcomes
The outcome will be aimed at reducing symptoms of Diabetes mellitus and to determine the therapeutic efficacy of Pathiriver chooranam
Time Frame: 3 months
Secondary Outcomes
- 1.To collect various siddha literatures and modern journals.(2.To evaluate Physio Chemical, Phyto Chemical, Bio Chemical analysis.)
Investigators
ABINAYA T
Government Siddha Medical College and Hospital