| CTRI Number |
CTRI/2026/01/102288 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Biological ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To See whether platelet-rich plasma can provide pain relief and faster healing,reducing the need for additional analgesics improving postoperative outcomes After Removal Of Tonsils |
|
Scientific Title of Study
|
THE ROLE OF TOPICAL PLATELET-RICH PLASMA IN ENHANCING WOUND HEALING AND REDUCING PAIN AFTER TONSILLECTOMY:A RANDOMIZED CLINICAL TRIAL |
| 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 Neha Shashikant Kalagi |
| Designation |
PG Student |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department Of Otorhinolaryngology And Head And Neck Surgery,Jawaharlal Nehru Medical College, Belgavi
Jawaharlal Nehru Medical College,JNMC KLE University Campus, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8618253435 |
| Fax |
0831 247 1350 |
| Email |
nehakalagi23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Shashikant Kalagi |
| Designation |
PG Student |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department Of Otorhinolaryngology And Head And Neck Surgery,Jawaharlal Nehru Medical College, Belgavi
Jawaharlal Nehru Medical College,JNMC KLE University Campus, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8618253435 |
| Fax |
0831 247 1350 |
| Email |
nehakalagi23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Shashikant Kalagi |
| Designation |
PG Student |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department Of Otorhinolaryngology And Head And Neck Surgery,Jawaharlal Nehru Medical College, Belgavi
Jawaharlal Nehru Medical College,JNMC KLE University Campus, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8618253435 |
| Fax |
0831 247 1350 |
| Email |
nehakalagi23@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Anilkumar S Harugop |
| Address |
Plot No.762,Kalpavruksha , Scheme No.40, Kuvempu Nagar, 5th Stage, Hanuman Nagar, Belgaum – 590 016. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harsha Hegde |
Department Of Otorhinolaryngology And Head And Neck Surgery Jawaharlal Nehru Medical College |
Department Of Otorhinolaryngology And Head And Neck Surgery Jawaharlal Nehru Medical College, Belgavi
Belgaum
KARNATAKA |
9075831999
2472550
done@jnmc.edu |
| Dr Harsha Hegde |
Department Of Otorhinolaryngology And Head And Neck Surgery Jawaharlal Nehru Medical College, |
Department Of Otorhinolaryngology And Head And Neck Surgery Jawaharlal Nehru Medical College,
Belagavi 590010
Belgaum
KARNATAKA |
9075831999
2472550
done@jnmc.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronic Adenotonsillitis
Chronic Tonsillitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Platelet Rich Plasma |
Platelet-rich plasma (PRP), an autologous blood derivative with a high concentration of platelets and bioactive growth factors. PRP has gained significant attention in regenerative medicine due to its ability to accelerate wound healing, modulate inflammation, and potentially reduce pain.
Using Platelet Rich Plasma Local Application After Tonsillectomy For 5 Min Duration |
| Comparator Agent |
Saline |
Control Group |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Age from 8 up to 18 years and patients who will undergo tonsillectomy. |
|
| ExclusionCriteria |
| Details |
Patients of Acute/Chronic Renal Failure/cardiac or respiratory disease/congenital cleft palate.
Bleeding disorders or current use of anticoagulant.
Patients with active infection, fever, or other systemic inflammatory conditions at the time of surgery.
Patients giving a history of allergy to platelet-rich plasma.
Inability or unwillingness to comply with follow-up visits or pain/bleeding assessment.
Parents not giving consent. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of topical Platelet-Rich Plasma (PRP) in promoting wound healing and reducing postoperative pain following tonsillectomy. |
To assess the patient
1hr,2hr,4hr,6hr,8hr,12hr,24hr,48hr,day 7th after Tonsillectomy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate whether platelet-rich plasma (PRP) can provide pain relief and faster healing, reducing the need for additional analgesics improving postoperative outcomes. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/02/2026 |
| 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="1"
Months="0"
Days="0" |
|
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
|
One emerging modality is platelet-rich plasma (PRP), an autologous blood derivative with a high concentration of platelets and bioactive growth factors. PRP has gained significant attention in regenerative medicine due to its ability to accelerate wound healing, modulate inflammation, and potentially reduce pain. This study aims to evaluate whether platelet-rich plasma can provide pain relief and faster healing, reducing the need for additional analgesics improving postoperative outcomes. |