Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia

B.P. Koirala Institute of Health Sciences82 enrolled

Overview

All eligible Herpes Zoster patients will be randomized into two groups. Group 1 will be the treatment group receiving Pregabalin 75 mg twice daily for 4 weeks in addition to other routine treatment. Whereas, group 2 will be the control group receiving all routine treatment similar to group 1 except Pregabalin. Instead control group will receive Placebo.

This study wants to see the role of Pregabalin in acute herpetic neuralgia pain reduction and for the prevention of post herpetic neuralgia incidence as compared to placebo group. For this purpose, all eligible Herpes Zoster patients will be randomized into two groups (41 patients in each group i.e.82 total patients). Group 1 will be the treatment group receiving Pregabalin 75 mg twice daily for 4 weeks in addition to other routine treatment. Whereas, group 2 will be the control group receiving all routine treatment similar to group 1 except Pregabalin. Instead of pregabalin, control group will receive Placebo. The pain will be evaluated in all patients in each follow visits (weekly follow up for 4 weeks then monthly follow up for next three months). If it is difficult for the patient to present physically, telephonic follow up will be done to find the pain score in the required time. Also, DLQI (Dermatological life quality index) will be assessed at the first and last visit of the patient. At the end, pain score will be compared between the two groups.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Herpes Zoster

Interventions

PregabalinDRUG

Pain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group)

PlaceboDRUG

Pain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients of HZ presenting within 72 hours of onset of rash, * With pain score 40 or above on 100 mm pain Visual Analogue Scale at the screening visit, * Giving written consent for the study. * Age between 18-70 years Exclusion Criteria: * HZ presenting after 72 hours of onset * Pain score less than 40 at baseline * Who took the stable doses of oral analgesics like: NSAIDs, acetaminophen, opioids and antidepressant within six hours of screening visit * Using Pregabalin and Gabapentin within last 72 hours * Nerve block therapy within the last 48 hours * History of hypersensitivity to the drug or its ingredients * Use of topical medications within 12 hours * Unable to come for follow up because of severe systemic illness * Significant hepatic and renal disease, * Bed ridden patients or those who are physically unfit for follow up visits. * Ethically considered vulnerable members- pregnant/lactating mothers/newborn/children below 12 years /physically or mentally challenged individuals/HIV/ AIDS/IV drug users

Locations (1)

B P Koirala Institute of Health Sciences

Dharān, Koshi, Nepal

Outcomes

Primary Outcomes

Percentage reduction of visual analogue scale (VAS) of pain in each visit in intervention and placebo group

Percentage reduction of visual analogue scale (VAS) of pain in each follow up visits in intervention group as compared to the placebo group

Time frame: Eight months

Secondary Outcomes

Prevention of Post Herpetic Neuralgia

Incidence of post herpetic neuralgia in pregabalin group and placebo group

Time frame: 12 months

Data from ClinicalTrials.gov

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