CTRI Number |
CTRI/2022/03/041450 [Registered on: 29/03/2022] Trial Registered Prospectively |
Last Modified On: |
28/03/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda Surgical/Anesthesia |
Study Design |
Single Arm Study |
Public Title of Study
|
kshar sutra application in fistula in ano. |
Scientific Title of Study
|
A clinical study of interception of fistulous tract with application of ksharsutra (IFTAK) technique using madhu saindhav aragbadhadi ksharsutra in the management of bhagandara (cryptoglandular fistula). |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Mohan Swarup Sharma |
Designation |
M.S. Scholar |
Affiliation |
Dr.SARVEPALLI RADHAKRISHNAN RAJASTHAN AYURVEDA UNIVERSITY JODHPUR |
Address |
Room number 135
pg department of Shalya Tantra
Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur Room number 135
pg department of Shalya Tantra
Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur Jodhpur RAJASTHAN 342037 India |
Phone |
8619308982 |
Fax |
|
Email |
tekchandparasar@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Rajesh Kumar Gupta |
Designation |
Associate professor |
Affiliation |
DSRRAU, Jodhpur |
Address |
Room No. 134 PG Department of shalya tantra
University College of Ayurveda, Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur Room No. 134 PG Department of shalya tantra
University College of Ayurveda, Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur Jodhpur RAJASTHAN 342037 India |
Phone |
9636520573 |
Fax |
|
Email |
guptadrrajeshkumargupta@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Mohan Swarup Sharma |
Designation |
MS Scholar |
Affiliation |
DSRRAU, Jodhpur |
Address |
PG Department of shalya tantra,DSRRAU Jodhpur PG Department of shalya tantra
University college of ayurved,
DSRRAU,Jodhpur Jodhpur RAJASTHAN 342037 India |
Phone |
8619308982 |
Fax |
|
Email |
tekchandparasar@gmail.com |
|
Source of Monetary or Material Support
|
OPD No-14
Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Hospital, Nagaur Road, JODHPUR |
|
Primary Sponsor
|
Name |
DSRRAU JODHPUR RAJASTHAN |
Address |
Room No. 135 PG Department of shalya tantra
University College of Ayurveda, Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur |
Type of Sponsor |
Government funding agency |
|
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 Rajesh kumar gupta |
DSRRAU Karwar,Jodhpur |
OPD NO 14, University college of ayurved hospital,DSRRAU Jodhapur
Jodhpur RAJASTHAN |
9636520573
guptadrrajeshkumargupta@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
The institutional cthics committee UCA jodhpur |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: bhagandar, (2) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: fistula, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
IFTAK |
Interception of fistulous tract with application of ksharsutra. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
ï¶ INCLUSION CRITERIA :
1.Blind fistula in ano.
2.Low anal fistula in ano.
3.All type tract of fistula in ano.
4.Recurrent fistula in ano.
|
|
ExclusionCriteria |
Details |
EXCLUSION CRITERIA:
1.Fistula in ano present with tuberculosis.
2.Diabetes Mellitus.
3.Hypertension.
4.ChronicAmoebias
6.Osteomyelitis of pelvic bone/femur.
7.Regional Ileiti
9.Any malignancies related with fistula in ano.
10.Chronic/acute ulcerative Colitis.
11.HIV&HBsAg Positive patient.
12.Crohn’s disease
13.Faecal Fistula & Uretero-Vaginal Fistula
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Centralized |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Improvement in the sign and symptoms of patients |
12 month |
|
Secondary Outcome
|
Outcome |
TimePoints |
healing of fistulous tract |
21 days |
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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
|
N/A |
Date of First Enrollment (India)
|
30/04/2022 |
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="0" Months="11" Days="15" |
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
|
ShalyaTantra
has wide scope in the management of Bhagandara(fistula-in-ano).
Most recognized therapy for the management of Bhagandara is KsharaSutratherapy.AcharyaSushruta has mentioned in NidanaSthana.According
to modern science a fistula is a abnormal passage way between two organs of the
body or between an organ and the exterior of the body. But we are concern here Bhagandara means fistula in ano.
Fistula in ano is a
condition which has been recognized as difficult surgical disease in all the
ancient and modern medical sciences of the world. It is the recurrent nature of
this disease which makes it more and more difficult for treatment. It has been
categories as a surgical condition and almost all the surgeons from Sushruta and also down to the modern
reputed surgeons of present times have realized that difficult course which this
disease offer for its surgical /medical /medico surgical methods of treatment. But
a multi dimensional or divergent approach to the treatment for a single disease
is only suggestive of the fact that none of these methods is complete and
satisfactory. Even AcharyaSushruta have been realized the
necessity of para-surgical approach. To
overcome these recurrent nature of Bhagandara
needs more and more comparative study. The present study is
undertaken as mentioned in Chakradutta5th
chapter “Arshachikitsaadhyayaâ€&46th
chapter “Bhagandarachikitsaadhyayaâ€&Bhaisajyaratnavali 50thchapter“Nadivranachikitsaadhyayaâ€. Fistula in ano is an
infective disease of anal canal usually caused by cryptoglandular
infection of anal crypts. In fistula in
ano there is an abnormal communication between two epithelial surface and the
track is lined by unhealthy granulation
tissue. Intercepion
Of Fistulous Tract With Application Kshar sutra [IFTAK]
technique with kshar sutra proved to be very effective and conduct interception
of fistlous tract with application of kshar sutra.
interception
of fistulous tract with application of kshar sutra (IFTAK)
is being practiced for treating complex and recurrent fistula in ano. In this
technique proximal part of fistulas track is intercepted at the level of
external sphincter along with the application of kshar sutra from site of
interception to the infected crypt in anal canal .This is aimed at to eradicate
the infected anal crypt with minimal damage to anal sphincter by using
ksharsutra (medicated seton).Use of ksharsutra cause extensive fibrosis and
favour proper healing which reduce the
chance of reccurence. |