| CTRI Number |
CTRI/2024/10/075405 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To See The Effect Of T-Shape Incision Mention In Ayurveda Followed By Cauterisation In The Managemnet Of Fistula-In-Ano. |
|
Scientific Title of Study
|
An Open Label Single Arm Clinical Study To Revalidate Sushrutokta Langalaka Incision Followed By Agnikarma In Vataja Bhagandara |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ROHIT |
| Designation |
PG SCHOLAR |
| Affiliation |
Rajiv Gandhi University Of Health Sciences,Banglore. |
| Address |
Room No 10 Department of PG And Ph.D Studies in Shalya Tantra JSS Ayurveda Medical
College and Hospital #41/E Lalithadripura, Mysuru-570028
Mysore KARNATAKA 570028 India |
| Phone |
9663669508 |
| Fax |
08212548360 |
| Email |
rohitshulsoor50@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR SIDDAYYA ARADHYAMATH |
| Designation |
Head and Professor |
| Affiliation |
Rajiv Gandhi University Of Health Sciences,Banglore. |
| Address |
Room No 10 Department of Shalya Tantra JSS Ayurveda Medical
College and Hospital #41/E Lalithadripura Mysuru - 570028
Mysore KARNATAKA 570028 India |
| Phone |
9449972788 |
| Fax |
08212548360 |
| Email |
drsiddesharadhyamath@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR SIDDAYYA ARADHYAMATH |
| Designation |
Head and Professor |
| Affiliation |
Rajiv Gandhi University Of Health Sciences,Banglore. |
| Address |
Department of Shalya Tantra JSS Ayurveda Medical
College and Hospital #41/E Lalithadripura Mysuru - 570028
Mysore KARNATAKA 570028 India |
| Phone |
9449972788 |
| Fax |
08212548360 |
| Email |
drsiddesharadhyamath@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Ayurveda Medical College and Hospital, #41/E, Lalithadripura Road, Mysuru- 570028 |
|
|
Primary Sponsor
|
| Name |
DR ROHIT |
| Address |
Department of PG Studies in Shalya Tantra, JSS Ayurveda Medical
College and Hospital, 41/ E, Lalithadripura Road, Mysuru,
Karnataka, 570028 |
| Type of Sponsor |
Other [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 ROHIT |
JSS Ayurveda Medical College and hospital |
Department of PG And Ph.D Studies in Shalya Tantra JSS Ayurveda Medical
College and Hospital #41/E Lalithadripura Mysuru 570028 Mysore KARNATAKA |
9663669508
rohitshulsoor50@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Ayurveda Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K605||Anorectal fistula. Ayurveda Condition: BAGANDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Cedanakarma, छेदनकरà¥à¤® followed by Agni karma | (Procedure Reference: : Bhagandara chikitsa adhaya 8 Sushruta Samhita Chikitsa Sthana, Procedure details: Pre-operative procedures: Physical fitness will be taken. Consent will be taken. Subject will be kept NBM 6 hours prior to surgery. Part preparation. Proctoglycerin enema. Injection TT 0.5 ml IM will be given stat. Injection Lignocaine 2% test dose 0.1ml subcutaneous will be given. Operative procedures: Under Spinal anesthesia with strict aseptic precautions, the part will be painted and draped in lithotomy position. Fistulous tract will be identified & Probed. Length & Direction of the Fistula tract will be noted. Langalaka incision (T-shaped) will be taken over the external opening of the Fistula track followed by Agni karma using Bipolar Cautery. The same procedure will be carried out for other Fistula tracts. Complete Heamostasis will be achieved. Dressing will be done using Jatyadi Taila. Post-operative procedures: Subject will be shifted to post operative ward. Foot end elevation. Restricted head movements will be adviced. The vitals will be monitored every 2 hrly. Catheterization will be done. Oral liquids will be started after 4 - 6 hours of surgery. Tab. Gandhaka Rasayana(2-0-2)A/F Tab Triphala Guggulu (2-0-2)A/F Triphala choorna 20gms will be given before food at night with lukewarm water.
The study with a single group consisting of 30 subjects. Total study duration is -42 days.
)
|
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with Vataja Bhagandara with multiple opening around the anal canal.
2.Subjects with Recurrent Anal Fistula.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating women.
2.Diagnosed cases of High Anal Fistula connected to PNS, Rectovesical Fistula, Rectovaginal Fistula and Rectoscrotal Fistula.
3.Fistula caused secondary to Tuberculosis, Crohn’s disease, Ulcerative colitis, CA of Rectum,HIV and Hepatitis B.
4.Uncontrolled DM and other Systemic disorders. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The prime aim of the treatment is to eradicate the tract and drain all collections from the site of infection while preserving anal continence and minimize the re-occurrence. |
1st, 7th, 14th, 21st and 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Revalidate the Langalaka incision in Vataja Bhagandara.
|
1st, 7th, 14th, 21st and 28th day |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
30/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Bhagandara is
a condition which has been recognized as a difficult surgical disease in the ancient and modern medical sciences of the
world, because the recurrent nature of this disease which makes it more and
more difficult for treatment. The most scientific description about Bhagandara
is given in Sushruta Samhita. Bhagandara is
a chronic illness which can be co-related to Fistula-in-Ano, though it is not
fatal but quite discomforting and troublesome to the patient, it also imposes a
psychological stress on the patient.The incidence of Fistula-in-Ano developing from an anal abscess ranges
from 26% to 38%, the prevalence rate of
Fistula-in-Ano is 8.6 cases per 100,000 population worldwide. In the men
the prevalence is 12.3 cases per 100,000 population and in woman it is 5.6
cases per 100,000 population.Despite of many
advancements in the surgical fields, the treatment of Fistula-in-Ano still
remains a great challenge. During the last century, numerous surgical
procedures like Fistulectomy, Fistulotomy, Advancement
Flaps, Fistula Clip Closure, LIFT technique, VAAFT procedure, Anal Fistula Plug
Repair, Fibrin Glue and Seton Techniques, each of these carries significant risk of pain,
delayed wound healing, incontinence and re-occurrence.The prime aim of
the treatment is to eradicate the tract and drain all collections from the site
of infection while preserving anal continence and minimize the re-occurrence. This has led surgeons to switch to alternative surgical
modalities of treatment like Ksharasutra and Agni karma procedures.Even when we go through the classics different
varieties of incision has been explained by Acharya Sushruta and Acharya Vagbhata for Bhagandhara.
In
the management of Vataja Bhagandara Acharyas
have described Chedana karma of interconnected Fistulae with multiple opening using
4 types of incisions
namely, Langalaka (T-shape), Ardha Langalaka (L-Shape),
Sarvatobhadraka (Circular-shape) and Gotirthaka (S-shape). Langalaka means ‘Hal’ i.e. plough used by farmer in field. The incision
have two arm perpendicular to each other and extending on either side
like ‘T’ shaped, the interconnected tracts can be easily probed and incised on
either side using this Langalaka incision. This emphasizes Acharya
Sushruta’s wide knowledge about the disease manifestation, management
and complications in Vataja Bhagandara .The current Ayurvedic surgical approach for Bhagandara includes Ksharasutra, Partial Fistulectomy and IFTAK. So far, no research
work has been carried out to evaluate the efficacy of Langalaka incision in Vataja
Bhagandara. Hence, an attempt will be made to revalidate the Langalaka incision
in Vataja Bhagandara.
Sample
Size:
The study with a single group consisting of 30 subjects. Pre-operative procedures: ·
Physical fitness will be taken. ·
Consent will be taken. ·
Subject will be kept NBM 6 hours prior to surgery. ·
Part preparation. ·
Proctoglycerin enema. ·
Injection TT 0.5 ml IM will be given stat. ·
Injection Lignocaine 2% test dose 0.1ml subcutaneous
will be given. Operative procedures:
· Under Spinal anesthesia with strict
aseptic precautions, the part will be painted and draped in lithotomy position.
· Fistulous tract will be identified
and Probed. Length & Direction of the Fistula tract will be noted.
· ‘Langalaka’ incision
(T-shaped) will be taken over the
external opening of the Fistula track
followed by Agni karma using Bipolar
Cautery.
· The same procedure will be carried
out for other Fistula tracts.
· Complete Heamostasis will be
achieved.
· Dressing will be done using Jatyadi
Taila.
Post-operative procedures:
· Subject will be shifted to post
operative ward.
· Foot
end elevation.
· Restricted
head movements will be adviced.
· The vitals will be monitored every 2
hrly.
· Catheterization will be done.
· Oral liquids will be started after 4 - 6
hours of surgery.
· Tab. Gandhaka Rasayana(2-0-2)A/F
· Tab Triphala Guggulu (2-0-2)A/F
· Triphala choorna 20gms HS will be given before food with
lukewarm water.
|