| CTRI Number |
CTRI/2023/09/057816 [Registered on: 18/09/2023] Trial Registered Prospectively |
| Last Modified On: |
13/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Histo pathological Study of Fistula Tract after Kshara Sutra |
|
Scientific Title of Study
|
Evaluation of fistulous tract by histo pathological study on the efficacy of Ksharasutra in 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 Shreeram P A |
| Designation |
PG scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda college and hospital |
| Address |
Sri Jayendra Saraswathi Ayurveda College and Hospital,
Bangalore Chennai Highway, Nazarathpet, Chennai, Tamil Nadu
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
8281631404 |
| Fax |
|
| Email |
shreerammarch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Vasudeva Reddy |
| Designation |
Professor, Department Of Shalya Tantra |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda college and hospital |
| Address |
Sri Jayendra Saraswathi Ayurveda College and Hospital,
Bangalore Chennai Highway, Nazarathpet, Chennai, Tamil Nadu
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
7200789978 |
| Fax |
|
| Email |
vdreddydr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arya S Menon |
| Designation |
Assistant Professor,Department of Shalya Tantra |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College |
| Address |
Sri Jayendra Saraswathi Ayurveda College and Hospital,
Bangalore Chennai Highway, Nazarathpet, Chennai, Tamil Nadu
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
8086799594 |
| Fax |
|
| Email |
dr.aryasmenon16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Jayendra Saraswathi AYurveda College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Shreeram P A |
| Address |
Department of Shalya Tantra, Room No-8, OPD block, Sri Jayendra Saraswathi Ayurveda College and Hospital,
Bangalore Chennai Highway, Nazarathpet, Chennai,
Thiruvallur, Tamil Nadu
Pin- 600123 |
| Type of Sponsor |
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 Shreeram P A |
Sri Jayendra Saraswathi Ayurveda College And Hospital |
Room No-8, Department of Shalya Tantra, Out Patient Department building,Sri Jayendra Saraswathi Ayurveda College and Hospital,
Bangalore Chennai Highway, Nazarathpet, Chennai
Thiruvallur
TAMIL NADU |
8281631404
shreerammarch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ,Sri Jayendra Saraswathi Ayurveda College and Hospital, Dept.of Ayurveda of SCSVMV,Nazarathpet, Chennai-600123 |
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: Sushrutha Samhita, Procedure details: The operation will be carried out under local anaesthesia. The operative area will be draped with
sterile cut sheet. First methylene blue dye will be passed in the tract to locate the directionand cavity
of fistula. Then index finger lubricated with lignocaine gel will be introduced slowly and gently into
the anal canal and with the other hand a lubricated probe will be introduced through the external
opening of the fistula. The index finger inside the anus will guide the probe. The probe)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients having Fistula in Ano.
2)Patients fulfilling the diagnostic criteria.
3)Patients who have signed the written informed consent.
|
|
| ExclusionCriteria |
| Details |
Patients suffering from:-
1) All infectious diseases
2) All Malignancies
3) Rectal polyps
4) Rectal prolapse
5) Uncontrolled diabetes mellitus and Hypertension
Anemia
6) Congenital anomalies of the anus and rectum
7) History of acute bleeding
8) K/C/O Ulcerative colitis and Crohn’s disease.
9) Pregnant And Lactating Women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Complete healing of the peri anal fistula with healthy granulation tissues in the histo pathological specimens |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complete healing of the fistula tract with healthy granulation tissues in the histo pathological specimens |
3 weeks |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/09/2023 |
| 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="0"
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
|
A track with epithelial lining that connects the anal canal to the perianal skin is known as a fistula-in ano. Anorectal abscesses are the most frequent cause of anal fistulas, while they can occur for a variety
of reasons. Men experience the prevalence at a rate of 12.3 cases per 100,000 and women at 5.6
instances per 100,000 respectively. The majority of diagnoses happen between the ages of 20 and 40,
with a 38-year-old average. Obesity, diabetes, smoking, hyperlipidemia, and a sedentary lifestyle are
risk factors for fistula formation. Sushruta discussed the genesis, clinical appearance, and therapy of
Bhagandara. The description of several varieties of Bhagandara (fistula-in-ano) is comparable to the
aetiopathogenesis of Fistula-in-ano as it is understood by contemporary medical research. It is a very
complex illness brought on by a number of causes including inflammatory bowel disorders like
Crohn’s disease and ulcerative colitis, as well as pyogenic, tubercular, lymphogranuloma inguinale,
and others. This is a condition where there is a need of invasive surgical interventions like
Fistulectomy, LIFT, Fistulotomy, VAAFT etc. which are costly, risk-bearing and need
hospitalization. The chances of recurrence after these surgeries are also high and development of
complications like fecal incontinence are also seen after these invasive procedures. Kshara Sutra is a
para surgical intervention mentioned in Ayurveda classics to treat Fistula in Ano which is a minimally
invasive and cost-effective treatment with a very low chance of recurrence and carries minimal amount
of risks. The efficacy of Kshara Sutra in Fistula In Ano has been studied and proved from time to
time, but no study has been conducted to understand the action of Kshara sutra on the tract on a cellular
level. Hence in order to study and understand the action of Kshara sutra on a cellular level this
Histopathological study is being conducted. Tissue from the tract of the fistula-in-ano can be
studied histo-pathologically to determine the efficacy of Kshara Sutra treatment. In this study, a biopsy will be taken from the fistulous tract at regular intervals and histopathological changes
will be observed to determine the action of Kshara Sutra and its mechanism in the healing
process |