management of Nadivrana with special reference to pilonidal sinus by two types of Ksharasutra.

Phase 1/2

Not yet recruiting

Conditions: Nerve root and plexus compressionsin diseases classified elsewhere. Ayurveda Condition: Manibandha Sandhigata Vata - carpel tunnel syndrome,

Lead Sponsor: Rajiv Gandhi University of Health sciences Karnataka Bengaluru

Brief Summary: Pilonidal Sinus is a quite troublesome disease which poseschallenge to the surgeon by virtue of its recurrence. Ayurveda stresses the use of Ksharasutra inthe management of Nadivrana which occur in the region of Kutakasthi(Coccyx)which is obviously Pilonidal Sinus. The Surgeries like Z-Plasty which requireshospitalization and burdens a person with high costs. The Usage of Guggulubased Apamarga Ksharasutra or Snuhi Kshira based Apamarga Ksharasutra may be aneffective alternative. The present study with 30 patients of two groups treatedby two different standardized treatment modalities may yield results which canbenefit the mankind.

Recruitment & Eligibility

Inclusion Criteria

1.Patients having signs & symptoms of Nadivrana namely- pain, sero purulent discharge, presence of Nadi (track) in the natal cleft (Sacrococcygeal region) confirmed by probing.
2.Presence of even multiple sinuses on the either side of the midline.

Exclusion Criteria

1.Sinus extending into the coccyx 2.Patients with evidence of malignancy 3.Patients with Diabetes Mellitus 4.Patients with Tuberculosis of spine, Osteomyelitis 5.History of HIV and other viral infections 6.Pregnant/ lactating women.
7.Patients who have completed participation in any other clinical trial during the past six (06) months.
(Exclusion of the patients will be done after necessary investigations in the Pathological Laboratory of the Institution free of cost- Namely- Complete blood count, Random Blood Sugar, Fasting Blood Sugar, Post prandial Blood sugar, ESR, Urine for Sugar, Chest X Ray, HIV 1 and HIV 2.).

Primary Outcome Measures

Name	Time	Method
Change in Subjective Parameters	120 DAYS
Change of the Tenderness	120 DAYS
Change in length of the tract assessed by Probing, Sinogram and USG of sacrococcygeal region	120 DAYS
Photographs of the subjects on baseline, Subsequent visits for Change of Ksharasutra and on last visit while concealing his/her identity.	120 DAYS

Secondary Outcome Measures

Name	Time	Method
Change in Subjective Parameters	Change of the Tenderness

Locations (1): Sri Jayachamarajendra Institute of Indian Medicine hospital
🇮🇳
Bangalore, KARNATAKA, India
Sri Jayachamarajendra Institute of Indian Medicine hospital
🇮🇳Bangalore, KARNATAKA, India
Dr Srinivas Masalekar
Principal investigator
masalekar@gmail.com