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Effect of herbal powder and kwath in the management of type II diabetes mellitus

Phase 2
Completed
Conditions
Health Condition 1: null- Patients of either gender in the age group of 30-65 yearsâ?¢Patients with classical signs and symptoms of Prameh/Madhumeha Health Condition 2: E119- Type 2 diabetes mellitus without complications
Registration Number
CTRI/2019/01/016863
Lead Sponsor
All India Institute Of ayurveda
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
56
Inclusion Criteria

Patients with classical signs and symptoms of Prameh/Madhumeha as stated below

Prabhuta Mutrata, Avila Mutrata, Pipasadhikya, Alasya, Utsahahani, Kshudhadhikya, Pindikodveshthana, Karapadatala Suptata, Daurbalya, Nidradhikya and Purishabadhdhata.

Criteria for diagnosis of DM by American Diabetes Association

Patients with random blood sugar level (RBS) >200 mg/dl, or

Fasting blood sugar (FBS) >126 mg/dl up to 375 mg/dl, or or

Postprandial blood sugar (PPBS) >200 mg/dl up to 500 mg/dl, and

Glycosylated haemoglobin > 6.5%.

Newly /Early diagnosed cases to be included as per following criteria:

Patients who are not taking any treatment for diabetes.

Patients who are not taking any conventional medicine for more than two months, whose sugar levels are raised and fall within the inclusive criteria mentioned above and are willing to take Ayurvedic treatment

Patient accidently diagnosed in routine check-up or when appeared with other complaints in the hospital.

Early diagnosed diabetic patients (less than 1yrs of history) who are asymptomatic and not taking any pharmacological drugs since last two months.

Exclusion Criteria

Patients less than 30 years and more than 65 years

Emergency cases in DM

Patients having insulin dependent DM (IDDM) and receiving insulin (type 1)

Excessive blood glucose: FBS > 375 mg/dl and PPBS > 500 mg/dl

Chronic complications like microvascular and macrovascular.

Patients with any anti-diabetic pharmacological drugs

Patients reporting to be hypersensitive to any of the proposed trial drug.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1.Glycosylated haemoglobin (in %) â?? to be assessed at the beginning and at the end of the trial) <br/ ><br>2.Blood sugar post parandial(in mg/dl) <br/ ><br>Timepoint: 3 months
Secondary Outcome Measures
NameTimeMethod
1.Blood sugar fasting and random (in mg/dl) <br/ ><br>2.Urine routine and microscopic examination â??albumin,sugar,casts/crystals,epithelialcells,pus cells. <br/ ><br>3.Haemogram with ESR, ketone bodies, Lipid Profile, Liver Function Test And Kidney Function Test <br/ ><br>Timepoint: 4 months
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