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Clinical Study comparing effectiveness of Topical Capsaicin and Oral Pregabalin in treating Diabetic Neuropathy.

Comparative study of efficacy between Topical Capsaicin 0.025% w/w, Capsaicin 0.075% w/w, and Oral Pregabalin in Diabetic Peripheral Neuropathy- A Randomized Controlled Clinical Trial. - CAPRE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033861
Enrollment
45
Registered
2021-05-28
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: E114- Type 2 diabetes mellitus with neurological complications

Interventions

Intervention1: Pregabalin: Oral Pregabalin 75 mg, Twice a day, Orally, for 8 weeks, was used as a standard intervention for the treatment of Diabetic Peripheral Neuropathy. Control Intervention1: Topi

Sponsors

Dr Faizuddin Ahmed
Lead Sponsor
Dr Nithin Reddy
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1) Subjects who are consenting to participate in the study. 2) Subjects must be ambulatory. 3) Subjects should experience at least one symptom of Diabetic Neuropathy in their peripheries like tingling, numbness, burning, and pricking sensation in the limbs.

Exclusion criteria

Exclusion criteria: 1) Subjects who arenâ??t consenting to participate in the study. 2) Subjects below 18 years of age and above 70 years. 3) Subjects with certain comorbid conditions which can trigger neuropathy like, CKD, HIV/AIDS, Vasculitis, Amyloid Polyneuropathy, Sarcoidosis, Guillain-Barre Syndrome, Women with hot flushes (Menopausal period), Postherpetic Neuralgia, Heavy Metal Poisoning, Skin rashes, Erythema, Psoriasis, Scleroderma, Steven- Johnsonâ??s Syndrome, Toxic Epidermal Necrolysis. 4) Subjects with physically debilitating conditions like Rheumatoid Arthritis, Osteoarthritis and other bone and joint disorders. Subjects suffering from physical trauma due to accidents. 5) Subjects who are takin neuropathy-triggering medications like Amiodarone, Cancer chemotherapeutic agents like Platinum based compounds, Paclitaxel, Anti-malarials like Chloroquine, Dapsone, other drugs like Isoniazid, Nitrofurantoin, Carbamazepine, Phenytoin, and Phenobarbital.

Design outcomes

Primary

MeasureTime frame
Impaired perception is assessed using a 100- point, specially designed Neuropathic Pain Scale Questionnaire (NPSQ) from 0 to 100. (0:None, 100: Extreme impairment); Pain was assessed using the Wong-Bakers Faces Pain Rating Scale, from 0 to 10 (0: None, 10: Unbearable pain).Timepoint: Two time points: Time 1 (T1) at baseline; and Time 2 (T2), 8 weeks after the initiation of assigned therapy.—

Secondary

MeasureTime frame
NILTimepoint: NIL—

Countries

India

Contacts

Public ContactFaizuddin Ahmed

Care Hospitals

faizuddinahmed111@gmail.com8977227504

Outcome results

None listed

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