| CTRI Number |
CTRI/2026/01/100154 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Intervention of NIAVR ointment and Povidone iodine ointment on PNS wound |
|
Scientific Title of Study
|
A RANDOMISED CONTROLLED CLINICAL TRIAL OF NIA VR OINTMENT AND POVIDONE IODINE OINTMENT IN THE MANAGEMENT OF POST OPERATIVE PILONIDAL SINUS WOUND |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohammad Dhukka |
| Designation |
PG Scholar Shalya Tantra |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
Shalya Tantra Department Room no 159 National Institute of Ayurveda Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
7285864516 |
| Fax |
|
| Email |
dhukkamohammad60@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Ashok Kumar |
| Designation |
Professor |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
Shalya tantra Department room no 159 National institute of Ayurveda Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9649180572 |
| Fax |
|
| Email |
ashok_hp1976@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Ashok Kumar |
| Designation |
Professor |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
Shalya tantra Department Room no 159 National institute of Ayurveda Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9649180572 |
| Fax |
|
| Email |
ashok_hp1976@yahoo.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Jaipur Rajasthan India Pin 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Jorawar singh gate Amer road Jaipur Rajasthan India 302002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Mohammad Dhukka |
Shalya Tantra Department IPD Room no 145 |
National institute of Ayurveda Hospital Jorawar Singh Gate Amer Road Jaipur
Jaipur
RAJASTHAN |
7285864516
dhukkamohammad60@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Intitutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L050||Pilonidal cyst and sinus with abscess, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A local application of Povidone iodine ointment |
30 patients of Post operative PNS wound will be treated by locl application of povidone iodine ointment |
| Comparator Agent |
Group B local application of NIAVR ointment |
30 patients of post operative PNS wound will be treated by local application of NIAVR ointment |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Post operative wound of PNS
Patient willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Post Operative wound of simple anal fistula,low anal fistula,secondary anal fistula,CA rectum
Patients with uncontrolled DM,Hypertension,Hepatitis-B,HIV,HCV ,STDs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Assessment criteria- Vas scale, odour, Bates Jensen wound assessment tool |
Assessment will be done on 7th,14th,21st and 28th POD |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in the quality of life of patient
|
Assessment will be done after 1 month |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/01/2026 |
| 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="2"
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
|
The term pilonidal sinus describes a condition found in the natal cleft overlying the coccyx, consisting of one or more,usually non-infected, midline openings, which communicate with a fibrous track lined by granulation tissue and containing hair lying loosely within the lumen.In this study Total of 60 cases of Post operative PNS wound will be enrolled and divided into 2 groups.Patients of Group A will be treated by Local application of Povidone iodine ointment and Group B patients by NIAVR ointment.Patients will be assessed by Pain ,Odour of the wound and bates jensen assessment tool & assessment will be done on 7th,14th,21st & 28th POD.Patient will be followed up on every 15th day for 2 months. |