| CTRI Number |
CTRI/2017/08/009585 [Registered on: 31/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
06/04/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study different systemic drugs for pain of herpes zoster |
|
Scientific Title of Study
|
To study the safety and efficacy of different systemic treatment modalities with antiviral drug for acute pain and chronic pain of herpes zoster-
A Pilot study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not Applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjiv Choudhary |
| Designation |
Professor |
| Affiliation |
DMIMS |
| Address |
Department of Dermatology, OPD-19, AVBRH,Jawaharlal Nehru Medical College, DMIMS, Sawangi, Wardha
Nagpur
MAHARASHTRA
442004
India |
| Phone |
9823165012 |
| Fax |
|
| Email |
sanjiv_choudhary26@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjiv Choudhary |
| Designation |
Professor |
| Affiliation |
DMIMS |
| Address |
Department of Dermatology, OPD-19, AVBRH,Jawaharlal Nehru Medical College, DMIMS, Sawangi, Wardha
Department of Dermatology, OPD-19, AVBRH,Jawaharlal Nehru Medical College, DMIMS, Sawangi, Wardha
Nagpur
MAHARASHTRA
442004
India |
| Phone |
9823165012 |
| Fax |
|
| Email |
sanjiv_choudhary26@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjiv Choudhary |
| Designation |
Professor |
| Affiliation |
DMIMS |
| Address |
Department of Dermatology, OPD-19, AVBRH,Jawaharlal Nehru Medical College, DMIMS, Sawangi, Wardha
Department of Dermatology, OPD-19, AVBRH,Jawaharlal Nehru Medical College, DMIMS, Sawangi, Wardha
Nagpur
MAHARASHTRA
442004
India |
| Phone |
9823165012 |
| Fax |
|
| Email |
sanjiv_choudhary26@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Acharya Vinoba Bhave Hospital attached to Jawaharlal Nehru Medical College, DMIMS, Sawangi, Wardha,Maharashtra 442004 |
|
|
Primary Sponsor
|
| Name |
Dr sanjiv choudhary |
| Address |
Acharya Vinoba Bhave Hospital attached to Jawaharlal Nehru Medical College, DMIMS, Sawangi, Wardha,Maharashtra 442004 |
| Type of Sponsor |
Other [Acharya Vinoba Bhave Hospital] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| No sponsor |
No sponsor. Hence not applicable. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjiv Choudhary |
Acharya Vinoba Bhave Hospital attached to Jawaharlal Nehru Medical College, DMIMS, |
Sawangi, Wardha
Nagpur
MAHARASHTRA |
9823165012
9823165012
sanjiv_choudhary26@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Medical Science |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Acute pain in Herpes Zoster, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Valacyclovir |
given to patients of Herpes Zoster as control group |
| Intervention |
Valacyclovir (1gm Tds x 7days) with pregabalin(75mg bd x 1 month) and Valacyclovir(1gm Tds x 7days),Pregabalin pregabalin(75mg bd x 1 month) with Methyprednisolone (16mg bd x 7 days) |
given to patients of Herpes Zoster as study group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) All patients of Herpes zoster of eruptions less than 72 hours duration.
2) Patients with age group 18 years to 70 years of both genders.
3) Patients willing to participate
3) Herpes zoster ophthalmicus without corneal involvement.
|
|
| ExclusionCriteria |
| Details |
1) Herpes zoster in pregnant and lactating patients.
2) Age less than 18 years and more than 70 years.
3) Herpes zoster ophthalmicus with keratitis.
4) Herpes zoster patients with diabetes mellitus, hypertension, tuberculosis, gastro-intestinal ulcer disease or with immune-compromised condition
5) Cases of disseminated Herpes zoster infection.
6) Patients of cardiac arrhythmia and cardiac disease
7) Patient with known hypersensitivity for drugs over study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in the severity of pain both in percentage (100-76%: excellent, 75-51%: good, 50-26%: moderate, 25% and less: poor) and grade (mild-pain perceived but day activities and night sleep not affected, moderate- day activities not affected but night sleep affected, severe-both day activities and night sleep affected) was noted.
|
measured at end of 1, 4, 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patients were monitored for side-effects during follow up period. |
monitored at end of 1, 4, 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
14/01/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
UNDER PROCESS |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Herpes zoster is a viral infection of skin caused by Varicella Zoster
virus. The most important symptom for which the patient seeks medical advice is
pain which is perceived before the development of rash and lasts even after its
resolution. The pain during first 30 days after onset of herpes zoster is known
as acute herpetic neuralgia. The results of considerable number of recent
prospective studies have demonstrated that more the severity of acute pain, greater
is the risk of developing post herpetic neuralgia (PHN). There is paucity of
studies regarding management of acute herpes zoster neuralgia. With this
background the study had been designed to target the disease in its initial
stage by using potent antiviral drug alone and in combination with anti
inflammatory and other pain relieving drug to evaluate their effect on acute
herpetic neuralgia. |