Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia and for the Prevention of Post Herpetic Neuralgia- a Randomized Controlled Trial

Conditions
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Herpes Zoster

Intervention / Treatment
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* Drug: Pregabalin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blinded randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pregabalin group<br>Group 1: Pregabalin tablet 75 mg orally twice daily for 4 weeks will be given to the subjects in this group along with other routine treatment Here, the intervention is administration of Pregabalin tablet 75 mg | Drug: Pregabalin<br>* Pain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group)<br>|
| Placebo Comparator: Placebo group<br>Group 2: Placebo tablet twice daily for 4 weeks will be given to the subjects in this group along with other routine treatment | Drug: Placebo<br>* Pain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Eight months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of Post Herpetic Neuralgia | Incidence of post herpetic neuralgia in pregabalin group and placebo group | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Herpes Zoster, Herpetic neuralgia, Pregabalin