| CTRI Number |
CTRI/2025/08/092858 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
09/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Understanding The Healing Effect Of Makshik Lavana Varti In The Management Of Nadivran. |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial To Evaluate The Efficacy Of MakshikLavana Varti In The Management Of Nadi Vrana (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 Akshay Nivrutee Tayade |
| Designation |
PG Scholar Shalyatantra Department |
| Affiliation |
CSMSS Ayurved College,Kanchanwadi ,Aurangabad |
| Address |
CSMSS Ayurved College Kanchanwadi,Aurangabad Department Of Shalyatantra Opd No -16
Chhatrapati Shahu Maharaj Shikshan Sanstha Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi,Aurangabad
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9764345220 |
| Fax |
|
| Email |
akshaytayade123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swapnil Vitthalrao More |
| Designation |
Associate Professor |
| Affiliation |
CSMSS Ayurved College ,Kanchanwadi,Aurangabad |
| Address |
CSMSS Ayurved College Kanchanwadi,Aurangabad Department Of Shalyatantra Opd No - 16
Chhatrapati Shahu Maharaj Shikshan Sanstha Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi,Aurangabad
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
8983357106 |
| Fax |
|
| Email |
dr.swapnilmore@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshay Nivrutee Tayade |
| Designation |
PG Schlor Shalyatantra Department |
| Affiliation |
CSMSS Ayurved College , Kanchanwadi |
| Address |
CSMSS Ayurved College Kanchanwadi, Aurangabad Department Of Shalyatantra Opd No -16
Chhatrapati Shahu Maharaj Shikshan Sanstha Ayurved Mahaviyalaya and Rugnalaya Kanchanwadi, Aurangabad
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9764345220 |
| Fax |
|
| Email |
akshaytayade123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chhatrapati Shahu Maharaj Shikshan Sanstha Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi,Aurangabad,Maharashtra,India 431011 |
|
|
Primary Sponsor
|
| Name |
C.S.M.S.S Ayurved College Kanchanwadi |
| Address |
Department Of Shalyatantra C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi,Aurangabad |
| Type of Sponsor |
Private medical college |
|
|
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 Akshay Nivrutee Tayade |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi ,Aurangabad |
Opd No 16,Shalyatantra Department Of C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi,Aurangabad
Aurangabad
MAHARASHTRA |
9764345220
akshaytayade123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CSMSS Ayurved College and Hospital Kanchanwadi Aurangabad |
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 | Intervention Arm | Procedure | - | vartiH, वर्तिः | (Procedure Reference: Shushrut Samhita Dr Ambikadutta Shastri Chikitsasthan Adhyay 17 shlok 37 and Bhaishyajya Ratnavali ,Vidhyodini Bhasha Tikasahit , By Kaviraj Shri Ambikadutta shastri Nadivran Chikitsa Adhyay 50 Verse no 10 page no 864 and Vrundamadhav Nadivran Chikitsa Adhyay Verse no 8 page no 452, Procedure details: Position will be given to the patient.
Cleaning and draping done.
Under local Anesthesia widening of the sinus track done if required .
If any foreign body or debris in the sinus track that will be removed .
Length and Direction of sinus will be measured by probe.
MakshikLavana Varti puran done .
Sinus is closed with a gauze piece.)
(1) Medicine Name: MakshikLavana Varti, Reference: Shushrut samhia Ayurveda Dr Ambikadutta shastri Chikitsasthan Adhyay 17 th shlok no 37 and BhaishyajyaRatnavali, Vidhyodini Bhasha Tikasahit , By Kaviraj shri Ambikadutta Shastri Nadivran Chikitsa Adhyay 50 Verse no 10 Page no 864 and Vrundamadhav Nadivran Chikitsa Adhayay Verse no 8 Page no 452, Route: Topical, Dosage Form: Varti/ Suppository, Dose: 1(NA), Frequency: od, Duration: 28 Days | | 2 | Comparator Arm | Procedure | - | tailam, तैलम् | (Procedure Reference: Sharangdhar Samhita Pandit Sarangdharacharya Containing Anjananidana of maharshi Agnivesha Annovated With Dipika Hindi Commentary by Dr Bramhanand tripathi Chaukhambha Surbharti Prakashan Vranasi ISBN Madhyam Khand Adhyay no 9 Verse no 168-171, Procedure details: Position will be given to the patient .
Cleaning and Draping will be done.
Under local Anesthesia Widening Of the Sinus Opening will be done if required .
If any foreign body or debris in the sinus track that will be removed .
The lenght and direction of the sinus track will be measured with a probe.
Jatyadi tailpuran will be done.
Sinus track closed with a gauze piece. )
(1) Medicine Name: Jatyadi Tail Puran, Reference: Sharandhar samhita pandit sarandharacharya containing anjananidan of Maharshi Agnivesha Annovated with hindi commentry by Dr Bramhanand Tripathi Chaukhambha Surbharti Prakashan Varanasi ISBN Madhyamkhand Adhyay 9 Verse no 168-170, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 28 Days |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients Presenting With Classical Signs And Symptoms Of Nadi Vrana With an External Opening At The Natal Cleft.
Straight Pilonidal Sinus Track Only.
Patient Having Subcutaneous Track.
Patient Will Be Selected Irrespective Of Sex Religion Prakriti Of The Patient Socio-economic Status And Profession. |
|
| ExclusionCriteria |
| Details |
Patient Having Age Group Below 19 yrs And Above 60 yrs.
Patient Having Co Morbidity.
Patient Having Multiple Sinus Or Complicated Sinus.
All The Immuno compressive Disorder. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vedana Strava Reduces After Insertion Of Makshik Lavana Varti in Pilonidal Sinus on 1st 7th 14th 21th 28 th day. |
Vedana Strava Reduces After Insertion Of Makshik Lavana Varti in Pilonidal Sinus on 1st 7th 14th 21th 28 th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Length of track decreases and Healing rate increases After Insertion of Makshik Lavana Varti in Pilonidal Sinus on 1st 7th 14th 21th 28th day |
Length of track decreases and Healing Rate increases After Insertion of Makshik Lavana Varti in Pilonidal Sinus on 1st 7th 14th 21th 28th day |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
21/08/2025 |
| 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
|
World wide Prevalance rate of Pilonidal Sinus is 0.7 %.
Males are afeected 2.2- 4times more frequently than females. During a polulation study involving college students, the incidence rate was found to be 1.1 % in males and 0.11 %in females.
The Prevalance rate of Pilonidal Sinus is low but nowadays due to changing lifestyle the incidence rate of Nadivran that is Pilonidal Sinus is increasing. The Availble surgical interventionis Z-plasty , Rhomboid flap , Incision and Drainage etc, which requires Spinal Anesthesia , which may lead to Secondary infection, its painful for the patient , all these procedures are costly and require time to heal and affect the patient daily work and also had higher recurrance rate. Management of Nadivrana as per Shushrut Samhita is Shastrakarma, Varti application ,Tail puran ,and Kshar sutra Application. Varti has a very good effect in that patients which cannot tolerate the pain and being afraid of surgical procedures . |