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Effect of Triphaladi granules and Rohitakadi churna in Diabetes Mellitus Type 2

Phase 4
Conditions
Health Condition 1: E119- Type 2 diabetes mellitus without complications
Registration Number
CTRI/2020/03/023876
Lead Sponsor
All India Institute of Ayurveda
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Closed to Recruitment of Participants
Sex
Not specified
Target Recruitment
40
Inclusion Criteria

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

2. Patients with classical signs and symptoms of Prameh or Madhumeha viz Prabhuta Mutrata Avila Mutrata Pipasadhikya Alasya Utsahahani Kshudhadhikya Pindikodveshthana Karapadatala Suptata Daurbalya Nidradhikya and Purishabadhdhata.

3. Inclusion criteria based on blood investigations

Fasting blood sugar FBS less than 140 mg per dl up to 200 mg per dl and

Patients with random blood sugar level RBS more than 200 mg per dl upto 350 or

Postprandial blood sugar PPBS more than 200 mg per dl up to 350 mg per dl and

Glycosylated haemoglobin more than 6.5 percent upto 10 percent

4. Newly or early diagnosed cases to be included as per following criteria

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 checkup or when appeared with other complaints in the hospital.

Early diagnosed diabetic patients less than 2yr of diabetic history and not taking any pharmacological drugs since last two months.

5. Frequency of urination 7 to 10 times per 24 hours or quantity equal or more than 2500ml per 24 hours

6. Presence of urine sugar

Exclusion Criteria

1. Patients with acute or chronic liver disease with elevated liver enzymes.

2. Patients with history of alcohol abuse.

3. Patients having insulin dependent DM type 1 and receiving insulin

4. Chronic complications like microvascular and macrovascular derangements.

5. Hyper or hypothyroidism

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

7. Patients on vitamin B supplementation, NSAIDs.

8. Pregnant women or 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.Glycosylated haemoglobin in % percent <br/ ><br>2.Blood sugar fasting post prandial random in mg/dl <br/ ><br>Timepoint: on 0th day and on 91st day <br/ ><br>
Secondary Outcome Measures
NameTimeMethod
1. Quality of Life in DMT2 <br/ ><br>2. Ayurveda parameters such as roga bala agni bala deha bala chetas bala and mutra pariksha 24 hour Quantity of urine <br/ ><br>3. Urine routine and microscopic examination albumin sugar casts crystals epithelialcells pus cells. <br/ ><br>4. Urine sugar concentration by colorimetric assessment. <br/ ><br>Timepoint: on 0th day and on 91st day <br/ ><br>
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