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CTRI Number  CTRI/2025/08/093445 [Registered on: 21/08/2025] Trial Registered Prospectively
Last Modified On: 20/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study on patients suffering with Nadivrana with special reference to Pilonidal sinus to evaluate the effect of Kshara sutra and Z plasty. 
Scientific Title of Study   A comparative clinical study to evaluate the effect of arka based apamarga kshara sutra and Z Plasty in shalyaja 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 Manoj D C 
Designation  PhD Scholar 
Affiliation  Sri Kalabyraveshwaraswamy ayurvedic medical college hospital and research centre bengaluru 
Address  Sri Kalabyraveshwaraswamy ayurvedic medical college hospital and research centre bengaluru
Sri Kalabyraveshwaraswamy ayurvedic medical college hospital and research centre pipe line road vijayanagara bengaluru
Bangalore
KARNATAKA
560104
India 
Phone  8050943402  
Fax    
Email  manoj.dc39@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S V Shailaja 
Designation  Professor and HOD 
Affiliation  Sri Kalabyraveshwaraswamy ayurvedic medical college hospital and research centre bengaluru 
Address  Department Of Shalya Tantra Sri Kalabyraveshwaraswamy ayurvedic medical college hospital and research centre bengaluru
Sri Kalabyraveshwaraswamy ayurvedic medical college hospital and research centre pipe line road vijayanagara bengaluru
Bangalore
KARNATAKA
560104
India 
Phone  8050943402  
Fax    
Email  shailajaramkumar@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manoj D C 
Designation  PhD Scholar 
Affiliation  Sri Kalabyraveshwaraswamy ayurvedic medical college hospital and research centre bengaluru 
Address  Sri Kalabyraveshwaraswamy ayurvedic medical college hospital and research centre bengaluru
Sri Kalabyraveshwaraswamy ayurvedic medical college hospital and research centre pipe line road vijayanagara bengaluru

KARNATAKA
560104
India 
Phone  8050943402  
Fax    
Email  manoj.dc39@gmail.com  
 
Source of Monetary or Material Support  
Sri Kalabyraveshwaraswamy ayurvedic medical college hospital and research centre pipeline road vijayanagara bengaluru, Karnataka, india 560104 
 
Primary Sponsor  
Name  Sri Kalabyraveshwaraswamy ayurvedic medical college hospital and research centre bengaluru 
Address  Sri Kalabyraveshwaraswamy ayurvedic medical college hospital and research centre pipeline road vijayanagara bengaluru karnataka india 560104 
Type of Sponsor  Other [Private ayurveda medical college hospital and research centre] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manoj D C  Sri Kalabyraveshwaraswamy ayurvedic medical college hospital and research centre bengaluru  Department of Shalya Tantra Sri Kalabyraveshwaraswamy ayurvedic medical college hospital and research centre pipeline road vijayanagara bengaluru
Bangalore
KARNATAKA 
8050943402

manoj.dc39@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SKAMCH RC Institutional Ethics Comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L059||Pilonidal cyst and sinus without abscess. Ayurveda Condition: NADIVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-kShArasUtra, क्षारसूत्र (Procedure Reference: Sushruta Samhita, Procedure details: Kshara sutra ligation once per 7 days)
2Comparator Arm (Non Ayurveda)-Z PlastyZ Plasty surgery
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects presenting with signs and symptoms of Shalyaja Nadivrana (Pilonidal Sinus) such as Pain, Pus discharge and presence of tract in the natal left which will be confirmed after probing.
Subjects having Shalyaja Nadivrana in the natal cleft (Pilonidal Sinus) aged between 18-60 years, irrespective of gender, caste and religion will be selected. 
 
ExclusionCriteria 
Details  Subjects having Shalyaja Nadivrana in the natal cleft (Pilonidal Sinus) diagnosed with any systemic disease interfering with the course of treatment like Uncontrolled Diabetes mellitus, Osteo myelitis, Tuberculosis, Immune compromised conditions, malignancy and Pregnancy will be excluded 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To see the difference in effectiveness, feasibility, recovery and chances of recurrence (if any) in two treatment groups Viz- Arka based Apamarga kshara sutra and Z-plasty in Shalyaja Nadivrana with special reference to Pilonidal sinus.
 
4 weeks and 6 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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/ Phase 3 
Date of First Enrollment (India)   01/07/2026 
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="3"
Months="0"
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  
Nadivrana is a disease of concern today which is defined as one which is having a track like a reed, the nature of which remains unhealed with the characteristics of discharge of pus caused due to the improper treatment of Pakwa Shopha. Nowadays, amongst all types of Nadivrana, the prevalence of Shalyaja Nadivrana which has baala (hair) embedded is higher in clinical practice. Lakshanas include ruja and puyasrava. Treatment includes- Upanaha, Chedana, Aaharana of Shalya, Ksharasutra, Varti, and Pratisaraniya Kshara. Shalyaja Nadivrana can be compared to the Pilonidal Sinus in contemporary sciences.
A pilonidal sinus is a cavity containing hair that is found typically above the level of the first piece of coccyx. A tuft of hair projects from its mouth. Amongst various sites like Webs of fingers, Axilla and Natal cleft, the commonest site is at the natal cleft. The Subject complains of blood stained foul discharge from the sinus at natal cleft. Pain and Tenderness are often associated with due to recurrent infection. The incidence of the disease at natal cleft is 26 per 1,00,000 population in India. The male is to female ratio is 3-4:19. Treatment options include- Excision of the Sinus, Open Surgery, Marsupialization, Z-plasty and Laser Ablation.
Amongst Shastra and Anushastra, Kshara is pradhana. Also, Kshara has Chedana, Bhedana, and Lekhana in addition to Shodhana, Ropana and Stambhanadi properties. Kshara sutra which imbibes all these properties is feasible, effective and can be performed on OPD basis. Z-Plasty is an effective treatment in contemporary science.
The treatment protocol of Nadivarna includes Kshara sutra. Apamarga kshara is mentioned in Ksharapakavidhi adhyayam. Arka ksheera can be used as a binding agent in the preparation of Kshara Sutra.
Shalyaja Nadivrana is a disorder that causes discomfort, pain and hampers day to day activities of the Subject. The suffering is due to the delayed approach of the Subject to the doctor. Hence, treatment of this is of utmost importance. As Shalyaja Nadivrana at natal cleft is one of the least explored area at par with contemporary science, so this study has been taken up to analyse the effect of Arka based Apamarga kshara sutra and Z-plasty in Shalyaja Nadivrana with special reference to Pilonidal sinus.
 
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