| CTRI Number |
CTRI/2018/08/015190 [Registered on: 06/08/2018] Trial Registered Prospectively |
| Last Modified On: |
08/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
management of Nadivrana with special reference to pilonidal sinus by two types of Ksharasutra. |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Guggulu based Apamarga Ksharasutra and Snuhi Kshira based Apamarga Ksharasutra in 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 Srinivas Masalekar |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurvedic medical college, Bengaluru |
| Address |
Dept. Of Shalyatantra
Govt. Ayurvedic Medical College, Bengaluru
Dept. Of Shalyatantra
Govt. Ayurvedic Medical College, Bengaluru
Bangalore
KARNATAKA
560009
India |
| Phone |
988632966 |
| Fax |
|
| Email |
masalekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Srinivas Masalekar |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurvedic medical college, Bengaluru |
| Address |
Dept. Of Shalyatantra
Govt. Ayurvedic Medical College, Bengaluru
Dept. Of Shalyatantra
Govt. Ayurvedic Medical College, Bengaluru
Bangalore
KARNATAKA
560009
India |
| Phone |
988632966 |
| Fax |
|
| Email |
masalekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Srinivas Masalekar |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurvedic medical college, Bengaluru |
| Address |
Dept. Of Shalyatantra
Govt. Ayurvedic Medical College, Bengaluru
Dept. Of Shalyatantra
Govt. Ayurvedic Medical College, Bengaluru
Bangalore
KARNATAKA
560009
India |
| Phone |
988632966 |
| Fax |
|
| Email |
masalekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi University of Health sciences karnataka, 4th T Block, tilaknagar, jayanagar, Bangalore |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi University of Health sciences Karnataka Bengaluru |
| Address |
4th T Block jayanagr bangalore |
| Type of Sponsor |
Other [govt run Health university of karnataka state] |
|
|
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 Srinivas Masalekar |
Sri Jayachamarajendra Institute of Indian Medicine hospital |
Department of Shalyatantra, OPD Room No 6,
Govt Ayurvedic Medical College, dhanwantri road, Bengaluru
Bangalore
KARNATAKA |
988632966
masalekar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Govt Ayurvedic Medical college, BAngalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G55||Nerve root and plexus compressionsin diseases classified elsewhere. Ayurveda Condition: Manibandha Sandhigata Vata - carpel tunnel syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Methodology in Group A
The patients will be treated with Guggulu based Apamarga ksharasutra prepared as per the standard method.
|
Procedure of Ksharasutra Application:
The procedure of ksharasutra application is explained to the patient. Patient will be placed in prone position. Under Local Anesthesia and under all aseptic precautions, Probing will be done using a malleable blunt probe to the sinus tract till the area of resistance is felt, then an artificial opening will be made over the skin using stab knife over the site of resistance through which probe will be taken out, thus making the sinus having two openings and then ksharasutra is ligated to the track. And on every 7th day ksharasutra is changed by rail-road method. Patient will be advised to attend normal day to day activities during the treatment period.
The observations will be made before the treatment and on every 7th day of fresh application of ksharasutra and the same will be recorded in the proforma of the case sheet prepared for the study
|
| Comparator Agent |
Methodology in Group B
The patients will be treated with Snuhi Kshira based Apamarga ksharasutra prepared as per the standard method.
|
Procedure of Ksharasutra Application:
The procedure of ksharasutra application is explained to the patient. Patient will be placed in prone position. Under Local Anesthesia and under all aseptic precautions, Probing will be done using a malleable blunt probe to the sinus tract till the area of resistance is felt, then an artificial opening will be made over the skin using stab knife over the site of resistance through which probe will be taken out, thus making the sinus having two openings and then ksharasutra is ligated to the track. And on every 7th day ksharasutra is changed by rail-road method. Patient will be advised to attend normal day to day activities during the treatment period.
The observations will be made before the treatment and on every 7th day of fresh application of ksharasutra and the same will be recorded in the proforma of the case sheet prepared for the study
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.)
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in Subjective Parameters
Change of the Tenderness
Change in length of the tract assessed by Probing, Sinogram and USG of sacrococcygeal region
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
|
| Outcome |
TimePoints |
Change in Subjective Parameters
Change of the Tenderness
Change in length of the tract assessed by Probing, Sinogram and USG of sacrococcygeal region
Photographs of the subjects on baseline, Subsequent visits for Change of Ksharasutra and on last visit while concealing his/her identity.
|
120 DAYS |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/01/2019 |
| 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="11"
Days="25" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet commenced |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Pilonidal Sinus is a quite troublesome disease which poses
challenge to the surgeon by virtue of its recurrence. Ayurveda stresses the use of Ksharasutra in
the management of Nadivrana which occur in the region of Kutakasthi(Coccyx)
which is obviously Pilonidal Sinus. The Surgeries like Z-Plasty which requires
hospitalization and burdens a person with high costs. The Usage of Guggulu
based Apamarga Ksharasutra or Snuhi Kshira based Apamarga Ksharasutra may be an
effective alternative. The present study with 30 patients of two groups treated
by two different standardized treatment modalities may yield results which can
benefit the mankind. |