| CTRI Number |
CTRI/2024/03/063957 [Registered on: 11/03/2024] Trial Registered Prospectively |
| Last Modified On: |
07/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate pain amelioration effect of Platelet Rich Plasma and Nutraceuticals in patients of post herpetic neuralgia |
|
Scientific Title of Study
|
Evaluate and compare effect of Platelet Rich Plasma(PRP) and Nutraceuticals in pain management of Post Herpetic Neuralgia |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajmala Jaiswal |
| Designation |
Senior Professor |
| Affiliation |
Pt B D Sharma PGIMS Rohtak |
| Address |
Department of Anesthesiology and Critical Care Pt BD Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8222897449 |
| Fax |
|
| Email |
para3007@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tanu Goyal |
| Designation |
Junior Resident |
| Affiliation |
Pt B D Sharma PGIMS Rohtak |
| Address |
Department of Anesthesiology and Critical Care Pt BD Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8107730334 |
| Fax |
|
| Email |
tanu98goyal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanu Goyal |
| Designation |
Junior Resident |
| Affiliation |
Pt B D Sharma PGIMS Rohtak |
| Address |
Department of Anesthesiology and Critical Care Pt BD Sharma PGIMS Rohtak
HARYANA
124001
India |
| Phone |
8107730334 |
| Fax |
|
| Email |
tanu98goyal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt BD Sharma PGIMS Rohtak |
|
|
Primary Sponsor
|
| Name |
Pt BD Sharma PGIMS Rohtak Haryana |
| Address |
Pt BD Sharma PGIMS Rohtak Haryana |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajmala Jaiswal |
Pt BD Sharma PGIMS Rohtak |
Pain Clinic, Department of Anesthesiology and Critical Care, Rohtak
Rohtak
HARYANA |
08222897449
para3007@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G543||Thoracic root disorders, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection of Platelet Rich Plasma in patients of post herpetic neuralgia. 15-20 ml of blood will be drawn and PRP is prepared. First soft spin for 10 minutes at 3500 rpm to separate upper Buffy coat and then again centrifuge for 7 minutes at 4000 rpm giving PRP |
A 26G needle will be used to inject PRP in Subcutaneous plane of areas with pain and itching. This intervention will be done in total of 20 patients selected randomly by computarised method. This reseach is expected to be done in 8 months. |
| Comparator Agent |
Oral administration of Nutraceuticals |
Patients of PHN will be given oral Vit C, Vit D, Calcium, Zinc, Magnesium, Potassium. This intervention will be done in total of 20 patients selected randomly by computarised method. This reseach is expected to be done in 8 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II suffering from chronic pain due to post herpetic neuralgia for at least 3 months |
|
| ExclusionCriteria |
| Details |
unwilligness to participate
history of local anaesthesia infiltration at the site of lesion
positive viral markers
patients on anti coagulants
patients on immunosuppressants/ steroids
malignancy
pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale |
2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient satisfaction score |
2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients of post herpetic neuralgia will be randomly divided into 2 groups. Group A will be given PRP and group B will be given Nutraceuticals. VAS Score will be assessed at the time of intervention, post intervention 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks |