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To study the efficacy of Pramehhara Kwatha in the management of Madhumeha w.s.r. to Type II Diabetes Mellitus

A clinical study to evaluate the effect of Pramehhara Kwatha in the management of Madhumeha w.s.r. to Type II Diabetes Mellitus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/046025
Enrollment
30
Registered
2022-09-29
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: E110- Type 2 diabetes mellitus with hyperosmolarity

Interventions

None listed

Sponsors

Principal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of type 2 diabetes mellitus having a. Fasting Plasma Glucose -126 to 200 mg/dl b. PPBS(2-hour Plasma Glucose Level) – 200 to 400 mg/dl c. HbA1C between - 6.5% to 9%

Exclusion criteria

Exclusion criteria: Subjects suffering from the complications of diabetes mellitus i.e. Diabetic neuropathy, diabetic nephropathy, diabetic retinopathy etc. which require an urgent treatment. Patients having major medical illness like cancer, concurrent infection like tuberculosis. Patients with uncontrolled hypertension. Patients with established diagnosis of CAD or any other clinically significant cardiovascular disease. Renal dysfunction (defined by eGFR Subjects who have completed participation in any other clinical trial during the past 3 months. Subjects with haemoglobin percentage Subjects with concurrent hepatic dysfunction (defined as AST and/or ALT >3 times of the upper normal limit) Uncontrolled acute pulmonary dysfunction requiring inhalational or systemic steroids. Pregnant/ lactating women. Subjects on systemic or oral steroids, oral contraceptives pills or estrogen replacement therapy.

Design outcomes

Primary

MeasureTime frame
To evaluate the efficacy of an Ayurvedic formulation Pramehhara Kwatha independently and also as add on therapy to Metformin for glycemic control in management of Madhumeha. Timepoint: Patient will be assessed after 2 weeks, 4 weeks, 8 weeks and at the end of trial (i.e 12 weeks).—

Secondary

MeasureTime frame
To assess the clinical safety of Pramehhara Kwatha in management of Madhumeha w.s.r. to Type II Diabetes Mellitus. Timepoint: At the 8th week and 12th week and remain connected with patients telephonically to know the A.D.Rs if there is any after completion of trial.—

Countries

India

Contacts

Public ContactDr Anant Bhardwaj

Rajiv Gandhi Govt. Ayu. Post Graduate College and Hospital Paprola (H.P)

drmsony@gmail.com9816842425

Outcome results

None listed

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