| CTRI Number |
CTRI/2025/08/093472 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison Between Two Drugs Apamarga and Arka in the Management of Nadivrana Pilonidal Sinus Using Pratisaraneeya Ksharakarma |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Arka Pratisaraneeya Ksharakarma And Apamarga Pratisaraneeya Ksharakarma In The Management Of Nadivrana With Special Reference to Pilonidal Sinus |
| 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 Rohan Dilip Pokale |
| Designation |
Post Graduate Resident in Shalya Tantra |
| Affiliation |
Dr N A MAGDUM AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE ANKALI |
| Address |
Dr N A Magdum Ayurvedic Medical College Hospital And Research Center Ankali 591213 Taluk Chhikodi Dist Belgaum Karnataka India
Belgaum
KARNATAKA
591213
India |
| Phone |
7972313696 |
| Fax |
|
| Email |
healinghands2204@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shaista Raj Jamadar |
| Designation |
Associate Professor in Shalya Tantra |
| Affiliation |
Dr N A MAGDUM AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE ANKALI |
| Address |
Dr N A Magdum Ayurvedic Medical College Hospital And Research Center Ankali 591213 Taluk Chikkodi Dist Belgaum Karnataka India
Belgaum
KARNATAKA
591213
India |
| Phone |
8369311754 |
| Fax |
|
| Email |
rajshaista786@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shaista Raj Jamadar |
| Designation |
Associate Professor in Shalya Tantra |
| Affiliation |
Dr N A MAGDUM AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE ANKALI |
| Address |
Dr N A Magdum Ayurvedic Medical College Hospital And Research Center Ankali 591213 Taluk Chikkodi Dist Belgaum Karnataka India
Belgaum
KARNATAKA
591213
India |
| Phone |
8369311754 |
| Fax |
|
| Email |
rajshaista786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr N A Magdum Ayurvedic Medical College Hospital and Research Centre Ankali |
|
|
Primary Sponsor
|
| Name |
Dr Rohan Dilip Pokale |
| Address |
Dr N A Magdum Ayurvedic Medical College Hospital and Research Centre Ankali, taluk Chikkodi Dist Belgaum 591213 Karnataka |
| Type of Sponsor |
Other [] |
|
|
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 Rohan Dilip Pokale |
Dr N A Magdum Ayurvedic Medical College Hospital and Research Centre Ankali |
Department Of Shalyatantra Room No 4
Belgaum
KARNATAKA |
7972313696
healinghands2204@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.NAMAMC-IEC |
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. Ayurveda Condition: NADIVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | pratisAraNIya-kShAraH, प्रतिसारणीय-क्षारः | (Procedure Reference: Sushruta Samhita Sutrasthana Adhyay 11/7, Procedure details: Patient will be taken in Jack Knife position on Operation Theatre Table Proper painting & draping to be done Local anesthesia with xylocaine infiltration around the external opening and whole natal cleft region Assessment of extension will be done by probing and awide elliptical incision to be taken from the external opening towards the natal cleft A wide incision will be taken and whole track will be excised Then careful examination for presence of hair or any other foreign bodies will be done Teekshna Apamarga Pratisaraneeya Kshara application over the wound and wait for Shatamatra Kala (100 seconds) followed by cleaning with Lemon Juice (Nimbu Swaras).)
| | 2 | Intervention Arm | Procedure | - | pratisAraNIya-kShAraH, प्रतिसारणीय-क्षारः | (Procedure Reference: Sushruta Samhita Sutrasthana Adhyay 11/7, Procedure details: Patient will be taken in Jack Knife position on Operation Theatre Table Proper painting & draping to be done Local anesthesia with xylocaine infiltration around the external opening and whole natal cleft region Assessment of extension will be done by probing and awide elliptical incision to be taken from the external opening towards the natal cleft A wide incision will be taken and whole track will be excised Then careful examination for presence of hair or any other foreign bodies will be done Teekshna Arka Pratisaraneeya Kshara application over the wound and wait for Shatamatra Kala (100 seconds) followed by cleaning with Lemon Juice (Nimbu Swaras).)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients between 18 - 60 years of age.
2.Patients with Acute or Chronic Sinus Single or Multiple Sinus Tract or Pilonidal abscess.
3.Patients will be selected irrespective of sex, occupation.
|
|
| ExclusionCriteria |
| Details |
1. Patients with Uncontrolled Diabetes Mellitus, Hypertension.
2. Patients diagnosed with Koch’s Disease, Hidradenitis Suppurativa, HIV, Hepatitis B and C.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Healing of Pilonidal sinus/ abscess after 15 days of treatment |
will be observed on 3, 5, 7, 9, 11, 13, 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No recurrence and way of healing of pilonidal sinus/ abscess after 3 and 1/2 months of duration |
After treatment, once in a month for three consecutive months |
|
|
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)
|
05/09/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 present title " A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF ARKA PRATISARANEEYA KSHARAKARMA AND APAMARGA PRATISARANEEYA KSHARAKARMA IN THE MANAGEMENT OF NADIVRANA (PILONIDAL SINUS)" a clinical study with total number of 40 registered patients who developed the disease will be selected and randomly allocated into two groups in each 20. Group A of 20 patients will receive standard Apamarga pratisaraneeya ksharakarma. Group B of 20 patients will receive trial drug Arka pratisaraneeya ksharakarma. Assessment will be done with subjective and objective criteria after total treatment duration that is three and half months. |