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Hypoglycemic Effect Using Ayurveda Treatment For The Management Of Madhumeha(Diabetes Mellitus Type 2)

Phase 4
Conditions
Health Condition 1: E119- Type 2 diabetes mellitus without complications
Registration Number
CTRI/2021/01/030636
Lead Sponsor
All India Institute of Ayurveda
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

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

1. Patients of either gender in the age group of 25-65years.

2. Patients with classical signs and symptoms of Prameh/Madhumeha viz Prabhuta

Mutrata, Avila Mutrata, Pipasadhikya, Alasya, Utsahahani, Kshudhadhikya,

Pindikodveshthana, Karapadatala Suptata, Daurbalya, Nidradhikya and

Purishabadhdhata.

3. Patients with random blood sugar level (RBS) >200 mg/dl up to 450

4. Fasting blood sugar (FBS) >110 mg/dl up to 300 mg/dl

5. Postprandial blood sugar (PPBS) >140 mg/dl up to 450 mg/dl

6. Glycosylated haemoglobin > 6.5%.

7. Newly /early diagnosed cases to be included as per following criteria:

i. 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.

ii. Patient accidently diagnosed in routine check-up or when appeared with other

complaints in the hospital.

iii. Early diagnosed diabetic patients (less than 2yr of diabetic history) and not

taking any pharmacological drugs since last two months

Exclusion Criteria

1. Patients having insulin dependent DM (type 1) and receiving insulin / OHA

2. Excessive blood glucose: FBS > 300 mg/dl and PPBS > 450 mg/dl

3. Emergency conditions in cases of DM.

4. Patients with acute/chronic liver disease with elevated liver enzymes.

5. Chronic complications like microvascular and macrovascular derangements.

6. Hyperthyroidism or hypothyroidism

7. Patients reporting to be hypersensitive to any of the proposed trial drugs.

8. Pregnant women/ lactating mothers

9. Participation in other clinical studies in past 12 weeks.

10. Takes psychotropic medications that raise blood glucose (e.g. atypical antipsychotics)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. Blood sugar fasting <br/ ><br>2. Post Prandial Blood Sugar LevelTimepoint: 0th day, 91st day
Secondary Outcome Measures
NameTimeMethod
1. Glycosylated haemoglobin (in %) â?? HbA1C <br/ ><br>2. Quality of life <br/ ><br>3. Ayurveda parameters such as Roga Bala, Agni Bala, Deha Bala, Chetas Bala <br/ ><br>4. Reduction in the classical signs and symptoms of Prameha/ Madhumeha. <br/ ><br>5. Urine routine and microscopic examination â?? albumin, sugar, casts/ crystals, epithelial cells, <br/ ><br>pus cells.Timepoint: 0th day, 91st day
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