| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kShArasUtra, क्षारसूत्र | (Procedure Reference: Sushruta Samhita, Procedure details: Kshara sutra ligation once per 7 days)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Z Plasty | Z 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 |
|
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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. |