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A clinical trial to assess efficacy of saptarangi bhavit vachadi ghana in diabetes mellitus type 2

Phase 2
Conditions
Health Condition 1: E119- Type 2 diabetes mellitus without complications
Registration Number
CTRI/2023/07/055334
Lead Sponsor
Shri krishna government ayurvedic college and hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1)Patients possessing sign and symptoms of Prameh (Diabetes mellitus)

2)Patient fulfilling the diagnostic criteria for Diabetes Mellitus framed by AMARICAN DIABETES ASSOCIATION.

3)FBS <126 TO 200mg /dl; PPBS <150 TO 300mg/dl

4)HbA1c <6.5%

5)Patient willing for clinical trials and ready to give written consent.

Exclusion Criteria

1) Patients not fulfilling the inclusion criteria

2) Patients of Sahaj Prameha and IDDM (type 1 diabetes mellitus) .

3) Pregnancy and lactating mothers, Gestational diabetes.

4) Patient with diabetic complications such as impaired renal functions.

5) Patient suffering from Secondary Diabetes.

6) Patients suffering from any serious systemic disorders such as uncontrolled hypertension, tuberculosis, carcinoma and HIV.

7) Patient below 30 years & above 60 years of age

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The effect of drug will be analysed on 1st 7th 14th 21st 28th 35th & after treatment by the means of change in subjective criteria & objective criteria (RBS, FBS, PPBS, HbA1c)Timepoint: Approx 45 days per patient
Secondary Outcome Measures
NameTimeMethod
Objectives: <br/ ><br>â?¢To know the efficacy & safety of this saptarangi bhavit vachadi ghana in diabetes mellitus type 2 associated with metabolic syndrome <br/ ><br>â?¢Detailed study of 7 drugs included in this saptarangi bhavit vachadi ghana. <br/ ><br>â?¢ Detailed Study of Diabetes mellitus type 2 associated with metabolic syndrome with special reference to Madhumeha. <br/ ><br>â?¢Preparation of formulation made by these seven Ayurvedic herbs.Timepoint: 1 Year 6 Months
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