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CLINICAL TRIAL ON PALSINURON CAPSULE FOR TREATMENT OF DIABETIC NEUROPATHY

CLINICAL TRIAL TO EVALUATE EFFICACY & SAFETY OF PALSINURON CAPSULE FOR TREATMENT OF DIABETIC NEUROPATHY - Palsinuron

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/07/009087
Enrollment
50
Registered
2017-07-20
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: null- Patients of Type II Diabetes Mellitus diagnosed with diabetic peripheral sensorimotor neuropathy

Interventions

Intervention1: Cap. Palsinuron: 2 Capsules twice daily after food with water Intervention2: Cap. Palsinuron: 2 Capsules (360mg each) orally twice daily after food with water for three months Control I

Sponsors

Ms SG Phyto Pharma Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Metabolically stable diabetic patients with symptomatic diabetic sensorimotor polyneuropathy (DSPN) 2. Patients of either sex between the age group of 35-65 years. 3. HbA1c not exceeding 11

Exclusion criteria

Exclusion criteria: 1. Patients who are insulin dependent. 2. Patients with other metabolic and endocrinal disorders. 3. Patients with other causes of Polyneuropathy. 4. Patients suffering from infectious diseases. 5. Patients with non healing ulcer/ulcers. 6. Patients with Diabetic Polyneuropathy in stage N3 of Dyckâ??s staging

Design outcomes

Primary

MeasureTime frame
â?¢ Changes in Neuropathy Symptom Score (NSS) and â?¢ Michigan Neuropathy Screening Instrument (MNSI). â?¢ Quality of Life; WHO QoL (BREF) Timepoint: Baseline and at the end of 3 months

Secondary

MeasureTime frame
Quality of Life; WHO QoL (BREF)Timepoint: Baseline and at the end of 3 months

Countries

India

Contacts

Public ContactDr Shreehari S Taklikar

Parul Institute of Ayurved Faculty of Ayurveda

niranjan.y@paruluniversity.ac.in02668260221

Outcome results

None listed

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