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Evaluation of added effect of Dhatrinisha Vati in Madhumeha i.e.Diabetes Mellitus type- II

Open labeled, active controlled, randomized evaluation of adjuvent effect of Dhatrinisha Vati in Madhumeha vis- a- vis Diabetes Mellitus type- II

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/08/007185
Enrollment
60
Registered
2016-08-16
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: null- Type 2 Diabetes mellitus

Interventions

Intervention1: Dhatri Nisha Vati: Dhatri Nisha Vati orally in the dose of 1gm tds will be administered along with conventional antidiabetic medicines(Oral hypoglycaemic agents) for 90 days Control Int

Sponsors

Maharashtra Arogya Mandals Sumatibhai Shah Ayurved Mahavidyalaya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. A known diabetic on treatment and a newly diagnosed diabetic. 2. Patients presenting classical symptoms of Madhumeha. 3. Patient with fasting blood sugar up to 220 mg% and post prandial blood sugar up to 300 mg%. 4. Patient showing good, fair and moderate control in HbA1c test. 5. Patients having fasting blood sugar in between 221 to 250 and post prandial 301 to 400 and if they are having good, fair, moderate control in HbA1C and normal fundoscopy.

Exclusion criteria

Exclusion criteria: 1.Patients with fasting blood sugar above 220 mg% and post prandial blood sugar above 300mg%. 2.Diabetes Mellitus Type-I and those who are under insulin therapy. 3.Pregnant and lactating mothers, known cases of Gestational Diabetes. 4.Patients with acute complications like Hyperglycemic coma, Ketoacidosis, and infections like gangrene. 5.Patients with chronic complications like Nephropathy, Neuropathy and Retinopathy. 6.Patients suffering from other diseases such as Tuberculosis, Cardiac diseases, HIV.

Design outcomes

Primary

MeasureTime frame
1.Assessment of pre and post treatment changes in HbA1c % (Glycosylated Hemoglobin %) values. 2. Assessment of change in blood sugar fasting and post prandial levels 3. Assessment of efficacy on the basis of subjective parameters Timepoint: 1. At base line and at the end of 3 Months. 2. 0, 30, 60, 90 Days 3. 0, 30, 60, 90 Days

Secondary

MeasureTime frame
Assessment of change in B.M.ITimepoint: 0, 30, 60, 90 Days;Assessment of change in Body weightTimepoint: 0, 30, 60,90 days

Countries

India

Contacts

Public ContactDr Vaishali Deshpande

Sumatibhai Shah Ayurved Mahavidyalaya

dr.bhagyashi555@gmail.com9637374196

Outcome results

None listed

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