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Effect of administration of Nisha-amalaki on glucose, lipid levels and other biomarkers in diabetic patients.

Effect of co-administration of Standardized Nisha-amalaki on oxidative stress, inflammation, glucose and lipid levels in type II diabetes patients receiving Anti-Diabetic-Agents: An Exploratory Clinical Study. - NIL

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/086303
Enrollment
60
Registered
2025-05-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: E08-E13- Diabetes mellitus

Interventions

None listed

Sponsors

Bharati Vidyapeeth DU Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age more than 18 years HbA1c between 6.5 to 8 percent Patient on the stable anti-diabetic medication for at least three months

Exclusion criteria

Exclusion criteria: Patients receiving anti-inflammatory drugs for chronic inflammatory disorder except low dose aspirin Presence of fever in preceding three weeks requiring antibiotics or infectious diseases with CRP more than 30mg dL or H O recurrent infections Anaemia (Hb less than 5Gms percent) Neutropenia (WBC count less than 200 per ml) Pregnancy or breast feeding Liver disease AST or ALT levels more than three times normal Kidney disease S creatinine more than 1.5mg percent Known patient of endocrine disorders other than T2DM Known patient of malignancy Known patient of Cardiac dysfunction arrhythmias or cardiac failure Known patient of Chronic Respiratory Diseases Known patient of demyelinating disease Patient who has participated in any other drug trial in 30 days Patient who has undergone major surgery in 30 days

Design outcomes

Secondary

MeasureTime frame
NILTimepoint: NIL

Primary

MeasureTime frame
Nisha amalaki is expected to have anti oxidant and anti inflammatory action along with add on effect on glycemic and lipid levelsTimepoint: 0 to 36 months

Countries

India

Contacts

Public ContactDr Sonali Palkar

Bharati Vidyapeeth DU Medical College Pune

palkarsh@gmail.com9881008717

Outcome results

None listed

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