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Comparative Efficacy of Waj and Pregabalin in Improving Neuropathic Symptoms in Patients with Diabetic Peripheral Neuropathy in Type 2 Diabetes Mellitus.

A Clinical Study on Evaluation of Comparative Efficacy of Waj versus Pregabalin in Diabetic Peripheral Neuropathy - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089131
Enrollment
150
Registered
2025-06-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications

Interventions

Intervention1: Waj: 2 Capsules of Waj (containing 500 mg powder of Acorus calamus Linn. in each capsule) two times a day. Control Intervention1: Pregabalin: One Capsule of Pregabalin 75 mg two times

Sponsors

NATIONAL INSTITUTE OF UNANI MEDICINE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed cases of DPN with Type 2 DM. History of DPN with or without medication within the period of 6 months to 60 months. Subjects of DPN with Toronto clinical scoring system score more than 5 up to 11. HbA1c less than 7. All genders. Age between 30 and 60 years. Normotensive (without taking any anti-hypertensive medicines)

Exclusion criteria

Exclusion criteria: Known cases of peripheral nerve dysfunction; vitamin deficiency (B12 and E), peripheral vascular disease (peripheral artery disease, varicose vein, deep vein thrombosis, Raynaud s disease, Buerger s disease). History of positive alcoholism. Patient on Insulin. Known history of thiazolidinedione antidiabetic agents (peripheral edema with pregabalin). Patients with a history of Cancer, Autoimmune diseases (Multiple sclerosis, GB syndrome, Myasthenia gravis), and vasculitis (Polyarteritis nodusa). Pregnant & lactating mothers.

Design outcomes

Primary

MeasureTime frame
Improvement in Visual Analogue Scale (VAS) Improvement in vibration perception threshold (VPT)Timepoint: For VAS at every 15th day (0th, 15th, 30th, 45th, and 60th). For VPT pre and post.

Secondary

MeasureTime frame
Improvement in TCSS. Improvement in DNS. Improvement in EuroQol 5 Dimension 5 Level (EQ 5D 5L).Timepoint: Every 15th day (0th, 15th, 30th, 45th, and 60th).

Countries

India

Contacts

Public ContactDR MOHD SHAHID

NATIONAL INSTITUTE OF UNANI MEDICINE

drmaquamri@gmail.com9341072974

Outcome results

None listed

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