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
|
|
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
|
|
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 | Drug | Classical | | (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: | 2 | Comparator Arm | Drug | Classical | | (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. | |