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

An open label randomised clinical trial to determine the efficacy of Rohitakadi Churna along with Triphaladi Granules in the management of Madhumeha with special reference to Diabetes Mellitus (type 2)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/023876
Enrollment
40
Registered
2020-03-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Tripahaladi Granules and Rohitakadi Churna: 5gm each orally twice a day morning after breakfast and night before meal daily with plain water for 90 days Control Intervention1: Triphalad

Sponsors

All India Institute of Ayurveda
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1.Glycosylated haemoglobin in % percent 2.Blood sugar fasting post prandial random in mg/dl Timepoint: on 0th day and on 91st day

Secondary

MeasureTime frame
1. Quality of Life in DMT2 2. Ayurveda parameters such as roga bala agni bala deha bala chetas bala and mutra pariksha 24 hour Quantity of urine 3. Urine routine and microscopic examination albumin sugar casts crystals epithelialcells pus cells. 4. Urine sugar concentration by colorimetric assessment. Timepoint: on 0th day and on 91st day

Countries

India

Contacts

Public ContactDr V G Huddar

All India Institute of Ayurveda

mahtorajaram88@gmail.com8877033663

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026