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Evaluation of safety and efficacy of Pramehakulantaka Rasa in the management of Madhumeha (Diabetes Mellitus TypeII)

Phase 1
Completed
Conditions
Health Condition 1: E119- Type 2 diabetes mellitus without complications
Registration Number
CTRI/2019/05/019339
Lead Sponsor
ational Institute of Ayurveda
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
64
Inclusion Criteria

1.Patients ready to give concern for the trial & willing to participate in the study for 3 months.

2.Patients between the age group of 31-70 years in either sex.

3.Newly diagnosed & confirmed cases of Mahdumeha (Type II Diabetes Mellitus) not talking allopathic drug or Insulin Therapy.

4.Patients with Fasting Blood Sugar (FBS) in the range of 126mg/dl â?? 250mg/dl or Post Prandial Blood Sugar (PPBS) in the range of 200mg/dl â?? 300 mg/dl and Glycosylated Haemoglobin (HbA1c) 6.5% - 9.0%.

5.Presence of Cardinal symptoms of Diabetes Mellitus eg. (3P- polyuria, polydipsia, polyphagia).

Exclusion Criteria

1.Patients below 31years of age & above 70 years of age.

2.Patients having Type I DM.

3.F.B.S. > 250 mg/dl and P.P.B.S. > 300 mg/dl.

4.Patients of Type II DM who are on insulin therapy and Drug induced DM.

5.Patients on allopathic anti-diabetic drug.

6.DM with complications and Madhumeha with ashadhya upadrava.

7.Patients having any serious illness like cardiovascular diseases, renal diseases, hepatic diseases, malignancy, any other endocrinopathies etc.

8.Pregnant and lactating mother.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Changes in the clinical symptoms of Mahdumeha (Type II Diabetes Mellitus)Timepoint: 90 days
Secondary Outcome Measures
NameTimeMethod
Changes in the objective parameters- F.B.S., P.P.B.S. & HbA1c. <br/ ><br>Timepoint: 90 Days
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