0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy: A Randomized, Double- Blind, Crossover, Placebo-Controlled Trial

Phase 3

Recruiting

• Conditions: Gastrointestinal disorders, Application site disorders, Infections, Nervous system disorders, Vascular disorders; capsaicin, neuropathic pain, diabetic neurop- athy, topical lotion

• Registration Number: TCTR20170407001
• Lead Sponsor: BANGKOK DRUG CO.,LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-07
• Study Completion: 2017-04-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. DM type 2 over 1 year
2. Clinical presentation of peripheral sensory such as burning pain
3.DN4 score from 4 points
4.Good consciousness to tell their score with informed consent agreement
5.No adding dosage of previous pain control medications at least 4 weeks
6.HbA1C 6.5-9.0%

Exclusion Criteria

1.Improper application site of skin for topical drugs such as abrasion wound.
2.Allergic history of Capsaicin
3.No intention to join the study with any reasons
4.Other previous medications used that effect to peripheral neuropathy such as Carboplatin, Cisplatin, Colchicine, Dapsone, Etoposide, Ethambutol, Indomethacin, Isoniazid, Lithium, Metronidazole, Phenytoin, Pyridoxine, Statins, Stavudine (d4T) or conditions worsening peripheral nerves following that poor nutritiion, kidney failure, chronic alcholism, vitamin deficiency, Hypothyroidism

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual analog scale (0-100 mm.) at 20 weeks after end of the intervention scale

Secondary Outcome Measures

Name	Time	Method
Short-form McGill Pain Questionnaire(SF-MPQ) at 20 weeks after end of the intervention scale,Neuropathic Pain Scale (NPS) at 20 weeks after end of the intervention scale