Clinical trial NCT03809702: Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia
Official title: Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia and for the Prevention of Post Herpetic Neuralgia- a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Herpes Zoster
Keywords: Herpes Zoster
Herpetic neuralgia
Pregabalin
Lead sponsor: B.P. Koirala Institute of Health Sciences
Sponsor class: OTHER
Collaborators: name: University Grants Commission
First posted: 2019-01-18
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage reduction of visual analogue scale (VAS) of pain in each visit in intervention and placebo group
timeFrame: Eight months
Secondary outcomes:
measure: Prevention of Post Herpetic Neuralgia
timeFrame: 12 months
Other outcomes:
Locations:
city: Dharān Bāzār
country: Nepal
facility: B P Koirala Institute of Health Sciences
state: Province 1
Study officials:
affiliation: B.P. Koirala Institute of Health Sciences
name: Suchana Marahatta, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References: