MANAGEMENT OF NADIVRANA WITH SPECIAL REFERENCE TO PILONIDAL SINUS BY TWO TYPES OF VARTIS.

Phase 2/3

Not yet recruiting

• Conditions: Pilonidal cyst and sinus without abscess. Ayurveda Condition: NADIVRANAH,

• Registration Number: CTRI/2022/08/044894
• Lead Sponsor: Dr Prasadshakti G Gannur

Brief Summary

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|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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-08-23
• Study Start: 2022-08-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ASSESSMENT CRITERIA:	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.
Subjective parameters.	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.
1 Pain-is asseed on visual analog scale.	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.
2 Burning sensation	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.
3 Itching sensation.	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.
Objective parameters	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.
4Discharge	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.
5Induration	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.
6Length 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 Measures

Name	Time	Method
Incidence of the Patients with classical signs and symtoms of nadivrana (pilonidal sinus)	in the OPD and

Trial Locations

Locations (1)

Shri J G Cooperative Hospital Society’s Ayurvedic Medical College Hospital and Research Center; 🇮🇳 Belgaum, KARNATAKA, India

Shri J G Cooperative Hospital Society’s Ayurvedic Medical College Hospital and Research Center

🇮🇳Belgaum, KARNATAKA, India

Dr Prasadshakti G Gannur

Principal investigator

9480062140

pgannur@gmail.com