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CTRI Number  CTRI/2022/08/044894 [Registered on: 24/08/2022] Trial Registered Prospectively
Last Modified On: 23/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Surgical/Anesthesia
Other (Specify) [Varti ]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   MANAGEMENT OF NADIVRANA WITH SPECIAL REFERENCE TO PILONIDAL SINUS BY TWO TYPES OF VARTIS. 
Scientific Title of Study   A Comparative Clinical Study on Efficacy of Snuhyadi Varti and Apamarga Kshara Sutra Varti in Management of Nadivrana with Special Reference to Pilonidal Sinus. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prasadshakti G Gannur 
Designation  Professor and HOD ,BLDEA’S AVS Ayurveda Mahavidyalaya, Vijayapur 
Affiliation  RGUHS, Karnataka. 
Address  BLDEA’s AVS Ayurveda Mahavidyalaya Hospital and Research Centre, Dept. of Shalyatantra (Surgery), OPD No. 3, Vidyanagar, Bagalakot road, Vijayapura, Karnataka, India.
Shri J G Cooperative Hospital Society’s Ayurvedic Medical College Hospital and Research Centre, Dept. of Shalyatantra, OPD No. 3, Dr. Gangadhar Nagar, Ghataprabha, Belgaum, Karnataka, India.
Belgaum
KARNATAKA
586101
India 
Phone  9480062140  
Fax    
Email  pgannur@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kulkarni Narayanrao Hanmantrao 
Designation  Professor, Dept. of PG Studies in Shalyatantra. 
Affiliation  RGUHS, Karnataka. 
Address  Shri J G Cooperative Hospital Society’s Ayurvedic Medical College Hospital and Research Centre, Dept. of Shalyatantra, OPD No. 3, Dr. Gangadhar Nagar, Ghataprabha, Belgaum, Karnataka, India.
Shri J G Cooperative Hospital Society’s Ayurvedic Medical College Hospital and Research Centre, Dept. of Shalyatantra, OPD No. 3, Dr. Gangadhar Nagar, Ghataprabha, Belgaum, Karnataka, India.
Belgaum
KARNATAKA
591310
India 
Phone  9449188822  
Fax    
Email  nhkshara@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prasadshakti G Gannur 
Designation  Professor and HOD ,BLDEA’S AVS Ayurveda Mahavidyalaya, Vijayapur 
Affiliation  SJGCO-HC AMC,GHATAPRABHA 
Address  BLDEA’s AVS Ayurveda Mahavidyalaya Hospital and Research Centre, Dept. of Shalyatantra (Surgery), OPD No. 3, Vidyanagar, Bagalakot road, Vijayapura, Karnataka, India.
Shri J G Cooperative Hospital Society’s Ayurvedic Medical College Hospital and Research Centre, Dept. of Shalyatantra, OPD No. 3, Dr. Gangadhar Nagar, Ghataprabha, Belgaum, Karnataka, India.
Belgaum
KARNATAKA
586101
India 
Phone  9480062140  
Fax    
Email  pgannur@gmail.com  
 
Source of Monetary or Material Support  
Shri. J. G. Co-Operative Hospital Society’s, Ayurvedic Medical College, Hospital and Research Center, Ghataprabha - 591 310, Karnataka, India. 
 
Primary Sponsor  
Name  Dr Prasadshakti G Gannur 
Address  Dept. of Shalyatantra (Surgery), OPD No. 3, BLDEA’s AVS Ayurveda Mahavidyalaya Hospital and Research Centre, vidyanagar, bagalakote road, Vijayapura, Kranataka, India.  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 Prasadshakti G Gannur  Shri J G Cooperative Hospital Society’s Ayurvedic Medical College Hospital and Research Center  Dept. of Shalyatantra, OPD No. 3, Shri J G Cooperative Hospital Society’s Ayurvedic Medical College Hospital and Research Centre, Dr. Gangadhar Nagar, Ghataprabha, Belgaum, Karnataka, India.
Belgaum
KARNATAKA 
9480062140

pgannur@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
SR J G COOPERATIVE HOSPITAL SOCIETYS AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE ETHICS COMMITTEE  Approved 
SRHI J G COOPERATIVE HOSPITAL SOCIETYS AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE ETHICS COMMITTEE  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 ArmDrugClassical(1) Medicine Name: snuhyadi varthi, Reference: .Bhaisajya Ratnavali,Chapter 51,Bhagandharrogadikara adyaya,p839, Route: Topical, Dosage Form: Varti/ Suppository, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information:
2Comparator ArmDrugClassical(1) Medicine Name: Apamarga kshrasutra varthi, Reference: Prof.P.J.Deshpande et.al.BHU VARANASHI, Route: Topical, Dosage Form: Varti/ Suppository, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients presenting with classical signs and symtoms of nadivrana pain,discharge and a sinus in intergluteal region.
2. The age group between 16-60yrs
3. Both gender.
 
 
ExclusionCriteria 
Details  1. Congenital sinus
2. Pilonidal sinus with systemic diseas DM,Bleedig disorder, AIDS,Tuberculosis Actinomycosis.
3. Osteomyelitis followed by sinus
4. Patient having Neoplastic Sinus
5. If the sinus tract is more than10 cm
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
ASSESSMENT CRITERIA:

Subjective parameters.
1 Pain-is asseed on visual analog scale.
2 Burning sensation
3 Itching sensation.
Objective parameters
4 Discharge
5 Induration
6 Length of the tract
 
Patient is assessed for above said parameters on 6th weeks. The observations will be recorded in the proforma of case sheet.
Management is terminated after 6 weeks of the commencement of the therapy and to check the recurrence of the disease 3 months follow up will be done fortnightly.

 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of the Patients with classical signs and symtoms of nadivrana (pilonidal sinus)
in the OPD and
IPD section at SRHI J G COOPERATIVE
HOSPITAL SOCIETYS AYURVEDIC MEDICAL
COLLEGE HOSPITAL AND RESEARCH
CENTRE will be Discussed with the points
related with the Age, Sex, Occupation, Diet, etc. 
Patient is assessed for above said parameters on every 7th day during treatment schedule ,up to 6 weeks. The observations will be recorded in the proforma of case sheet.
Management is terminated after 6 weeks of the commencement of the therapy and to check the recurrence of the disease 3 months follow up will be done fortnightly.
 
 
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)   25/08/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Pilonoidal sinus is the disease that commonly arises in the hair follicles of the natal cleft of sacro coccygeal area, incidence is reported 26/100,000 population. Usually affects hairy adult males than females, it usually presents as an abscess or chronically discharging painful sinus tract. Inspite of mode of presentation, painful nature of condition causes significant morbidity, often with a protracted loss of normal activity.

 In Ayurveda shalyaja nadi vrana explained by Sushruta can be correlated with Pilonidal sinus by considering its clinical features.

 

In Modern Science, the management option varies from Phenol injection,  lancing, exision of the  tract and complex rotation flap. All these   modalities are more invasive, not cost effecticve, require hospitalization and are not free from post operative complications and moreover they have high recurrence rate. Hence, it has been thought of to evaluate simple, safe and effective principle from the doctrines of Ayurveda for the management of nadivrana w.s.r.to Pilonidal sinus.

 In Ayurveda different   effective treatment modalities for Shalyaja Nadi Vrana have been explained. Many works have been done on ksharasutra at various cetres across the country. Mechanical introduction of kshara sutra is complex and painful procedure and   it is aiso having some limitations in its use as in multiple sinuses.  Varti kalpana is one of conservative line of management mentioned in classics and can be practiced at OPD level. After Varti Chikitsa  patient can do his routine work without any disturbance.

In Bhaishajya Ratnavali,  Snuhyadi Varti (Ref: .Bhaisajya Ratnavali,Chapter 51,Bhagandharrogadikara adyaya,p839) is mentioned for treatment of Nadivruna and Bhagandara1

As there is recurrence with existing surgical and other modalities of Modern Science, the need of the hour is to search for an effective and innovative treatment modality which can fulfill criteria of an ideal treatment which can prevent recurrence, cost effective and doesnot require hospitalization. 

 Varti Chikitsa has been ear marked by all the Acharyas and is found to be very effective in Nadi Vrana and also to avoid its recurrence. Therefore, in the present study, it has been planned to evaluate the efficacy of Snuhyadi Varti in the screened patients of Nadi Vrana wsr to Pilonidal Sinus and its efficacy will be assessed and compared with already established Apamarga Kshara Sutra varti in the management of Nadivrana.

 
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