| CTRI Number |
CTRI/2025/02/080639 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study between LIFT and IFTAK in the management of anal fistula. |
|
Scientific Title of Study
|
A Comparative study of ligation of fistulous track in the inter-sphincteric plane(LIFT) versus interception of fistulous track with application of ksharsutra (IFTAK) in the management of Bhagandara with special reference to trans-sphincteric 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 Vibhav Dwivedi |
| Designation |
M.S. Scholar |
| Affiliation |
Government Ayurvedic PG College And Hospital Chaukaghat Varanasi |
| Address |
Department Of Shalya tantra Government Ayurvedic PG College And Hospital Chaukaghat Varanasi
Varanasi
UTTAR PRADESH
221001
India |
| Phone |
9118988199 |
| Fax |
|
| Email |
vibhavdwivedi001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman Yadav |
| Designation |
Professor and H.O.D PG department of Shalya Tantra |
| Affiliation |
Government pg Ayurvedic Medical College And Hospital Chaukaghat Varanasi |
| Address |
Department Of Shalya tantra Government Ayurvedic PG College And Hospital Chaukaghat Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9451965767 |
| Fax |
|
| Email |
yadavsuman2073@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mrigank Shekhar |
| Designation |
Lecturer |
| Affiliation |
Government Ayurvedic PG College And Hospital Chaukaghat Varanasi |
| Address |
Department Of Shalya tantra Government Ayurvedic PG College And Hospital Chaukaghat Varanasi
Varanasi
UTTAR PRADESH
221001
India |
| Phone |
9453788863 |
| Fax |
|
| Email |
drmrigank.bhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic PG College And Hospital Chaukaghat Varanasi,Uttar Pradesh,221002,India |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic PG College And Hospital Chaukaghat Varanasi |
| Address |
Department Of Shalya Tantra Government Ayurvedic PG College And Hospital,Chaukaghat,Varanasi,Uttar Pradesh,221002 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vibhav Dwivedi |
Government Ayurvedic PG College And Hospital, Chaukaghat, Varanasi. |
OPD No.25 of Department of Shalya Tantra Government Ayurvedic PG College And Hospital,Chaukaghat,Varanasi,Uttar Pradesh,221002
Varanasi
UTTAR PRADESH |
9118988199
vibhavdwivedi001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government PG Ayurveda College and Hospital,Varanasi ,U.P Mahayogi Guru Gorakhnath Ayush University Gorakhapur U.P. |
Approved |
|
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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, क्षारसूत्र | (Procedure Reference: Shahu M. Published by In A manual on Fistula in Ano Ksharasutra Therapy 1st ed. NRC, Deptt. Of Shalya Tantra IMS BHU 2015 Page No.184, Procedure details: The IFTAK technique, based on Parks crypto-glandular theory of fistula-in-ano, targets the infected anal crypt to promote healing. By applying ksharsutra to one arm of the fistulous track, the infected crypt is eradicated, allowing the other arm to heal spontaneously. The procedure involves identifying the infected crypt, intercepting the track at the external sphincter level, applying ksharsutra to the proximal track. Failure to identify the infected crypt may lead to recurrence)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Ligation of fistulous track in the intersphincteric plane,LIFT | The LIFT procedure is a quick, simple method for managing fistula in ano. It involves identifying the fistula tract, ligating it, isolating it between the two anal sphincters |
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Non-healing boil like structure at perianal area
2)Itching at perianal region
3)Constipation
4)Age between 20-60 years.
5)Trans-sphincteric fistula in ano
6)Horse shoe fistula in ano
7)Patient irrespective of occupation, sex and religion will be considered for study. |
|
| ExclusionCriteria |
| Details |
1)Fissure-in-ano
2)Inter-sphincteric fistula in ano
3)Supra-sphincteric fistula in ano
4)Extra-sphincteric fistula in ano
5)Thrombosed pile mass.
6)First and second degree haemorrhoids
7)Third and fourth degree haemorrhoids.
8)The pathological conditions such as HIV I & II, HBsAg ,HCV. etc. will be excluded from the study.
9) Pregnancy.
10)Uncontrolled diabetes.
11)Cancer.
12) Anaemic patients.
13)Any other systemic disease.
14)Age below 20year and above 60 year
15)Addiction-drug, alchol, tobacco etc. |
|
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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 |
| Cutting and Healing of Fistulous Track |
28-42Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduce pus discharge,cure burning sensation & pain,increase quality of life,regulates bowel habit. |
3-4Months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/02/2025 |
| Date of Study Completion (India) |
12/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
12/06/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Conclusion - The present study was undertaken to evaluate and compare the efficacy and applicability of IFTAK (Interception of Fistulous Tract with Application of Kshara Sutra) and LIFT (Ligation of Intersphincteric Fistula Tract) in the management of Bhagandara (fistula-in-ano). Based on the clinical observations, therapeutic outcomes, and statistical analysis of the collected data, the following conclusions were drawn. The findings of the study provide valuable insight into the effectiveness of both treatment modalities and their role in achieving disease resolution, promoting wound healing, reducing recurrence, and preserving continence. The detailed conclusions derived from the study are presented below.
There was an excellent reduction in parameters like, Pain, Discharge,Tenderness,Track obliteration and created wound in treated group as compared to control group . IFTAK reduces long hospital stay of patients as well as negligible recurrence. IFTAK is another alternative method in Management of Bhagandar. On comparing both therapies, the percentage of relief in Group A was noted more clinically as well as statistically significant in Pain, Discharge,Tenderness,Track obliteration and created wound than Group B. Complete remission of symptoms of Bhagandar was more in patients treated in Group A than of Group B. It can be practiced with minimum operative set up and can be carried with least instrumentation. Thus, Null hypothesis is rejected and alternate hypothesis is accepted i.e. There is statistically significant difference observed in trial group as compared to control group in terms of Pain, Discharge,Tenderness,Track obliteration and created wound and H1 is accepted that is Interception of fistulous track with application of ksharsutra (IFTAK) is more effective than Ligation of fistulous track in the inter sphincteric plane (LIFT) in management of Bhagandara.
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