| CTRI Number |
CTRI/2025/11/097638 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
31/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparing ayurvedic medicated threads for the treatment of anal fistula for the cutting and healing of tract |
|
Scientific Title of Study
|
Efficacy of kumari-karanja ksharasutra against apamarga ksharasutra in low anal fistula-an open label randomized controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JANNATHUL SHERIN M |
| Designation |
PG SCHOLAR |
| Affiliation |
Government Ayurveda College Kannur |
| Address |
Department of Shalyatantra
Government Ayurveda Medical college Pariyaram kannur
Kannur
KERALA
676503
India |
| Phone |
7592007978 |
| Fax |
|
| Email |
jannathulsherin13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K GANGADARAN |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurveda College Kannur |
| Address |
Department of Salyatantra
Govt. Ayurveda Medical College
Pariyaram,kannur
Kannur
KERALA
676503
India |
| Phone |
9447876659 |
| Fax |
|
| Email |
drkganga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jannathul sherin M |
| Designation |
PG scholar |
| Affiliation |
Government Ayurveda College Kannur |
| Address |
Department of shalyatantra
Government Ayurveda College Pariyaram Kannur
Kannur
KERALA
676503
India |
| Phone |
7592007978 |
| Fax |
|
| Email |
jannathulsherin13@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jannathul sherin M |
| Address |
Government Ayurveda Medical college,Kannur |
| 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 |
| Jannathul Sherin M |
GOVERNMENT AYURVEDA COLLEGE HOSPITAL PARIYARAM |
OPD and IPD DEPARTMENT OF SHALYATANTRA
Kannur
KERALA |
7592007978
jannathulsherin13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, Govt. Ayurveda College Kannur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
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|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: BAGANDARAH, (2) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: BAGANDARAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kShArasUtra, क्षारसूत्र | (Procedure Reference: Susruta samhita, Procedure details: The participants will be comfortably laid in the lithotomy position. A malleable copper probe will be introduced into the external opening & it will be carefully introduced along the track. The finger kept in the anal canal will support the movement of the probe towards the internal opening. The probe will be brought out of the internal opening and then it will be carefully taken out through the anal canal.kumari-karanja Ksharasutra of suitable length will be passed through the eye of the probe and the probe will be pulled out to position the thread in the track. The two ends of the thread will be tied outside the anal orifice. Surgical pad will be applied to the area and the participant will be shifted to the post-operative ward.)
(1) Medicine Name: Kumari-karanja ksharasutra, Reference: susruta samhita, Route: Rectal, Dosage Form: Not Applicable, Dose: 1(NA), Frequency: sos, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | kShArasUtra, क्षारसूत्र | (Procedure Reference: Susruta samhita, Procedure details: The participants will be comfortably laid in the lithotomy position. A malleable copper probe will be introduced into the external opening & it will be carefully introduced along the track. The finger kept in the anal canal will support the movement of the probe towards the internal opening. The probe will be brought out of the internal opening & then it will be carefully taken out through the anal canal.Snuhi-apamarga Ksharasutra of suitable length will be passed through the eye of the probe & the probe will be pulled out to position the thread in the track. The two ends of the thread will be tied outside the anal orifice. Surgical pad will be applied to the area and the participant will be shifted to the post-operative ward.)
(1) Medicine Name: snuhi- apamarga ksharasutra, Reference: susruta samhita, Route: Rectal, Dosage Form: Not Applicable, Dose: 1(NA), Frequency: sos, Duration: 7 Weeks |
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed low anal fistula
Participants with Written consent
Age group - 20-60 years |
|
| ExclusionCriteria |
| Details |
Fistula in known cases of colorectal carcinoma, crohn’s, ulcerative colitis and tuberculosis
Participants with uncontrolled Diabetes mellitus and Hypertension
Known case of HIV, Hepatitis B and any venereal diseases
Patient who are known case of severely compromised cardiopulmonary status
Known cases of Bleeding disorder. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Unit cutting time
Healing time
Reduction in pain and discharge |
84 days/fistulous tract cut through |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain and discharge |
84 days/fistulous tract cut through |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="38" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/11/2025 |
| Date of Study Completion (India) |
17/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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)
|
Fistula-in-ano is an inflammatory track lined by granulation tissue and fibrous tissue, which has an external opening in rectum, anal canal or skin around the perianal region. The prevalence of fistula-in-ano is higher due to lifestyle modifications. Patient frequently develop low anal fistula among the various types. Most fistula are thought to arise from cryptoglandular infections with resultant perianal abscess. The symptoms generally affect one’s quality of life from discomfort to infection due to drainage. The most effective surgical procedures now a days are fistulectomy and fistulotomy; nonetheless, there are certain post-operative problem such as incontinence and recurrence. In ayurvedic perspective, bhagandara can be correlated with fistula-in-ano. A well proven therapeutic option for fistula-in-ano with a very low recurrence rate is ksharasutra application. Various combination of ksharasutra have been tried to develop for the management. In kumari based karanja ksharasutra, kumari has anti-inflammatory and wound healing properties. Karanja is a drug mentioned in ksharagana by Acharya susruta which has significant action in wound healing such as anti-inflammatory and anti-microbial. The effect of kumari-karanja ksharasutra on cutting and healing of fistulous track along with pain and discharge against apamarga ksharasutra on 38 participants analyzing in the open label randomized controlled study with weekly changes in ksharasutra. Participants who meet inclusion criteria was assigned to study group and control group, drawn from the OPD and IPD of Government Ayurveda College Hospital Kannur. Application of the Sutra was done after baseline analysis of the participants. Assessment was done based on objective parameters such as unit cutting time, healing effect and discharge, pain as subjective parameter, on the basis of scoring system. Significant healing progression and reduction in discharge were observed in both groups.Intergroup comparison demonstrated relatively earlier healing in the Kumari-karanja group during intermediate follow-up periods.
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