To Compare the Efficacy of Phalatrikadi Vasti and Phaltrikadi Kwath orally in one group with Standard Metformin Treatment in second group in Managing Type 2 Diabetes (Prameha) in age group 20-60 years.

Evaluation of Comparative efficacy of Phalatrikadi Vasti followed by Phalatrikadi Kwath versus standard treatment (Tab Metformin) in the management of Diabetes Mellitus Type II (Prameha): A Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/092716

Enrollment

Registered

2025-08-08

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Patients willing to give written informed consent Patient with either sex having age between 20 to 60 years Patients recently diagnosed for uncomplicated NIDDM (less than 6 months) and having 1 Fasting blood sugar level 126 to 200 mg per dl 2 Post meal blood sugar level 140 to 300mg per dl Patients with type-2 DM for 6 months but not taking any other anti-hypoglycemic drugs Diabetic Patients suffering from controlled hypertension Systolic blood pressure not more than 140 mmHg or an average Diastolic Blood Pressure not more than 90 mmHg Patient fit for Vasti Karma as per the Ayurvedic classics Newly Diagnosed Diabetic patients who are not willing for Allopathic medications

Exclusion criteria

Exclusion criteria: Patients suffering from IDDM (Insulin dependent diabetes mellitus) and patients with Type-2 Diabetes on insulin therapy Patients suffering from Juvenile Diabetes or Gestational diabetes (2024 ICD-10-CM Diagnosis Code O24.4) Impaired glucose tolerance (2024 ICD-10-CM Diagnosis Code R73.02) DM with complications Retinopathy, Nephropathy, neuropathy, previous history of coma Patients suffering from any current acute illness, uncontrolled hypertension Pregnant and Lactating women Anorectal Pathologies

Design outcomes

Primary

Measure	Time frame
To assess and compare the efficacy of Phalatrikadi Vasti followed by Phalatrikadi Kwath and Tab Metformin over Blood sugar levels (Fasting and Post prandial), Urine Sugar level in Diabetes Mellitus Type IITimepoint: at baseline 16 day 48 day	—

Secondary

Measure	Time frame
Comparison and assessment of efficacy of Phalatrikadi Vasti followed by Phalatrikadi Kwath and Tab Metformin over Blood sugar levels (Fasting and Post prandial), Urine Sugar level in Diabetes Mellitus Type IITimepoint: at baseline 2 weeks 2 days 6 weeks 6 days	—

Countries

India

Contacts

Public ContactDr Prasad Rukminikant Mirge

Mahatma Gandhi Ayurveda College Hospital and Research Centre wardha,

shweta.parwe@dmiher.edu.in9403142270

Outcome results