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A clinical trial to study the effect of novel ayurvedic choorna in patients with Type 2 Diabetes mellitus

An open labelled randomized controlled clinical study to evaluate the anti-hyperglycemic activity of novel ayurvedic choorna in the management of prameha vis-a-vis type2 diabetes mellitus - nil

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/10/028201
Enrollment
40
Registered
2020-10-01
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: - Health Condition 2: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Novel Ayurvedic choorna: 6g BD for 3 months Control Intervention1: Nishamalaki choorna: 6g BD for 3 months

Sponsors

Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan Karnataka
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Subjects of all gender and age group between 30-60 years will be included. Subjects with FBS greater than or equal to 126mg/dl and or PPBS greater than or equal to 200mg/dl will be included. Subjects with HbA1c greater than or equal to 6.5% Diagnosed cases of Type2 Diabetes Mellitus. Subjects with and without signs and symptoms of Prameha vis-a-vis Type2 Diabetes Mellitus will be included.

Exclusion criteria

Exclusion criteria: Subjects with history of Diabetes Mellitus associated with complications like diabetic nephropathy, retinopathy, neuropathy, infectious wounds and gangrene will be excluded. Patients with known systemic disorders like; cardiac illness, renal pathologies, other endocrinal diseases, uncontrolled hypertension, infectious conditions and debilitating illness which interfere with intervention will be excluded. Patients of Type 2 Diabetes Mellitus who are on OHA and Insulin treatment will be excluded. Subjects on any other medications, drug and alcohol abuse, Steroids and Estrogen replacement therapy will be excluded. Pregnant and the lactating women will be excluded.

Design outcomes

Primary

MeasureTime frame
Fasting Plasma Glucose Level Two-hour Plasma Glucose Level HbA1c Timepoint: 3 month

Secondary

MeasureTime frame
Clinical symptoms of Diabetes Mellitus. WHO-QOL. Timepoint: 3 month

Countries

India

Contacts

Public ContactDr Govinda Sharma

Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan

profpnrao@gmail.com9448064277

Outcome results

None listed

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