| CTRI Number |
CTRI/2024/02/062307 [Registered on: 06/02/2024] Trial Registered Prospectively |
| Last Modified On: |
20/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the efficacy of chitraka kshara sutra with apamarga kshara sutra in the treatment of bhagandara(Fistula in ano) |
|
Scientific Title of Study
|
A controlled clinical study to evaluate the effect of Arka ksheera based Chitraka kshara sutra over Apamarga kshara sutra in the management of Bhagandara (Fistula in ano). |
| 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. Nikhil Sood |
| Designation |
Second Year PG scholar |
| Affiliation |
Shree jagadguru gavisiddeshwara ayurvedic medical college and hospital, Koppal |
| Address |
Department of post graduation studies in Shalya Tantra.Shree jagadguru gavisiddeshwara ayurvedic medical college and hospital koppal.
Koppal KARNATAKA 583231 India |
| Phone |
9591058858 |
| Fax |
|
| Email |
nikhil.s14698@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Geetanjali hiremath |
| Designation |
Associate Professor |
| Affiliation |
Shree jagadguru gavisiddeshwara ayurvedic medical college and hospital, Koppal |
| Address |
Department of post graduate studies in Shalya tantra,
Shree jagadguru gavisiddeshwara ayurvedic medical college and hospital, koppal
Koppal KARNATAKA 583231 India |
| Phone |
7760346752 |
| Fax |
|
| Email |
sanjalihiremath@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Geetanjali hiremath |
| Designation |
Associate Professor |
| Affiliation |
Shree jagadguru gavisiddeshwara ayurvedic medical college and hospital, Koppal |
| Address |
Department of post graduation studies in Shalya tantra.
Shree jagadguru gavisiddeshwara ayurvedic medical college and hospital,Koppal
Koppal KARNATAKA 583231 India |
| Phone |
7760346752 |
| Fax |
|
| Email |
sanjalihiremath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree jagadguru gavisiddheshwara ayurvedic medical college post graduate studiesand research centre |
|
|
Primary Sponsor
|
| Name |
Shree jagadguru gavisiddeshwara ayurvedic medical college postgraduate studies and research center |
| Address |
Shree jagadguru gavisiddeshwara ayurvedic medical college postgraduate studies and research center, Gavimath Campus,opp. toGavimath |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nikhil Sood |
Shree jagadguru gavisiddeshwara ayurvedic medical college post graduate studies and research center |
Department of Shalya Tantra Room No 16
Koppal
KARNATAKA Koppal KARNATAKA |
9591058858
nikhil.s14698@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ICECSJGAMCH |
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 | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: 14VD shri Santosh kumar sharma Rasakamadhenu compiled by sri chudamani misra with suvivrtti Hindi commentary Edited Acharya shri Gularj sharma Mishra chaukhambha Orientalia Reprinted edition 2010 uttarardha 48 124 128 pg 322 323., Procedure details: Arka Ksheera based Chitraka Kshara sutra ligation
Kshara Sutra will be changed once in every week till 7 weeks)
| | 2 | Comparator Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: 14VD shri Santosh kumar sharma Rasakamadhenu compiled by sri chudamani misra with suvivrtti Hindi commentary Edited Acharya shri Gularj sharma Mishra chaukhambha Orientalia Reprinted edition 2010 uttarardha 48 124 128 pg 322 323, Procedure details: Arka Ksheera based Chitraka Kshara sutra ligation
Kshara Sutra will be changed once in every week till 7 weeks
)
|
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either gender diagnosed with all Low Anal Fistulae except suprashincteric fistula.
Equal to or within 5cm Tract length of fistula
|
|
| ExclusionCriteria |
| Details |
High Anal Fistulae Complicated Fistula multiple Fistula Extra-sphincteric Fistula.
Secondary Fistula in ano due to Ulcerative colitis Crohns disease Tuberculosis Carcinoma of rectum and Patients with systemic illness like Uncontrolled Diabetes mellitus Hypertension and if tract length is more than 5 cm.
HIV and HbsAg positive patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Arka ksheera based Chitraka Kshara sutra in terms of time taken by kshara sutra to cut through the tract with the application of unit cutting time formula. |
7 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recurrence of Bhagandara treated with Arka ksheera based Chitraka kshara sutra. |
7 weeks |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
20/02/2024 |
| 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="10" Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Fistula-in-ano is a tract lined
by granulation tissue which connects perianal skin superficially to anal canal;
anorectum or rectum deeply. It usually occurs in a pre-existing anorectal
abscess which burst spontaneously. Fistula-in-ano can be Cryptoglandular (90%) and
Non cryptoglandular (10%).Fistula-in-ano according to park’s classification; Intersphincteric,
Transphincteric, Suprasphincteric, Extrasphincteric. It is having clinical
features like one or more external openings may be present with induration of
the surrounding skin, seropurulent discharge and pain.1
In
modern surgical treatment of Fistula in ano are Fistulotomy, Fistulectomy,
Gluing of the Fistula tract, Anal Fistula Plug (AFP), Advancement flaps, LIFT
technique, VAAFT procedure and Seton technique.2
Fistula
in ano has been a troublesome disease to both patient and Physician to cure
because of its recurrence rate. Fistula in Ano at modern parlance is a common
anorectal condition prevalent in the populations worldwide. The overall
incidence is about 9 cases per 100,000 population per year and those in their
third, fourth and fifth decades of life are most commonly affected3.
And is more common in young adult males than females with the ratio of
2:1 respectively.4
Bhagandara
is a disease which causes tear or discontinuity in the region of Bhaga, Guda
and Basti. According to Acharya Sushrutha, Bhagandara is a condition
which is developed from bursting of painful and suppurated Pidika. He
clearly differentiated the Bhagandara Pidika with other Pidika
stating that if the Pidika is within two fingers area of Guda (anus),
deep rooted, with pain and fever, it should be considered as Bhagandara
Pidika.5Bhagandara (fistula-in-ano) is one among the most common
anorectal disease.
It
can be correlated with fistula-in-ano because of its similar clinical features.
Five types of Bhagandara have been described as Shataponaka (Vataja),
Ushtragreeva (Pittaja), Parisravi (Kaphaja), Shambhukavarta (Tridoshaja),
Unmargi (agantuja).6Anorectal diseases like Bhagandara (fistula
in ano) is said callous to be cured and Acharya Sushrutha had have
considered Bhagandara one among the Ashta Mahagadas (eight grave
disorders). Bhagandara is one of the oldest disease in Medical Science
to be known.7
In modern world
the medical science is so advanced in all aspects of treatments and surgical
procedures but still the treatment for the fistula-in-ano is not yielding
satisfactory results because of its high reccurrence rate. Kshara Sutra is
one of the chief modalities in the treatment of Bhagandara in Ayurvedic
science.8Exploration of the new plants for the preparation of Kshara
as a better substitute to Apamarga Kshara is the need of the hour
as it is available in the beginning of the year but Chitraka is
available throughout the year. The idea came in mind to include Chitraka
Kshara in place of Apamarga Kshara in making kshara
sutra. To find out an effective alternative to Apamarga kshara sutra9
in view of easy availability throughout the year and attempt will be made to
check the early healing of fistulous tract, an Arka ksheera based Chitraka
kshara sutra10 over Apamarga kshara sutra were opted for
their clinical evaluation. |