A manufacturing process of Swarna Makshika Bhasma and its clinical trial in Diabetes type 2 Patients.

Phase 1

Completed

• Conditions: Health Condition 1: null- Madhumeha (DM TYPE II)Health Condition 2: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2015/08/006114
• Lead Sponsor: IPGT and RA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-02-11
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 110

Inclusion Criteria

1.Patients having classical symptomatology of Madhumeha (Prabhutamutrata, Avilamutrata etc) will be selected from O.P.D. and I.P.D. of I.P.G.T. & R.A., Hospital, Jamnagar.

2.Symptoms of Diabetes (Polyuria, Polydypsia, Polyphagia and Weight loss.)

3.Both the sexes having Age between 30 years to 60 years.

4.Patients having Blood sugar â?? FBS >= 126 mg/dl

â?? PPBS >= 200 mg/dl

Exclusion Criteria

1.Age below 30 and above 60 years.

2.Malignant and accelerated Hypertension.

3.Patients having chronic complications of Diabetes Mellitus

a.Microvascular: Retinopathy, Neuropathy, & Nephropathy.

b.Macrovascular: Coronary artery disease, Peripheral vascular disease & Cerebro-vascular disease.

c.Other chronic debilitating diseases like STD etc.

4.Pregnant women.

5.Lactating mothers.

6.Secondary Diabetes mellitus.

7.Patients of any other severe illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is expected that the trial drugs will exert a significant action over blood sugar level.Timepoint: up to 8 weeks

Secondary Outcome Measures

Name	Time	Method
By maintaining the helthy level of BSL, The drug will control conditions associated with Madhumeha(DM TYPE II) like Polyuria, Polydypsia, Polyphagia and Weight loss etc.Timepoint: up to 8 weeks.