| CTRI Number |
CTRI/2025/02/080152 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A pilot clinical trial to know the effectiveness of Siddha Karanool (medicated thread) treatment in Anal fistula |
|
Scientific Title of Study
|
A Pilot Clinical Trial to explore the efficacy of Siddha treatment in Powthiram (Anal fistula) using Karanool (Seton) coated with Sesame Salt, Papain and Turmeric – A Chemical ablation method. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr G J Christian |
| Designation |
Professor and Head of the Department |
| Affiliation |
National Institute of Siddha |
| Address |
Head of the Department, Department of Noi Naadal, National Institute of Siddha, Tambaram Sanatorium, Chennai - 47.
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Sharmila |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Noi Naadal, National Institute of Siddha, Tambaram Sanatorium, Chennai - 47.
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8508025180 |
| Fax |
|
| Email |
sharmila1121995@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Sharmila |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Noi Naadal, National Institute of Siddha, Tambaram Sanatorium, Chennai - 47.
TAMIL NADU
600047
India |
| Phone |
8508025180 |
| Fax |
|
| Email |
sharmila1121995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Prof. Dr G J Christian, Head, Department of Noi Naadal, National Institute of Siddha, Tambaram Sanatorium, Chennai -47, Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
Investigator funded |
| Address |
Prof. Dr G J Christian, Head, Department of Noi Naadal, National Institute of Siddha, Tambaram Sanatorium, Chennai -47, Tamil Nadu, India |
| 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 |
| Prof Dr G J Christian |
OPD room no 20/21 Department of Noi Naadal, Ayothidoss Pandithar Hospital |
Ayothidoss Pandithar Hospital, National Institute of Siddha, Chennai 47, Tamil Nadu, India
Kancheepuram
TAMIL NADU |
9962545930
christianvijila@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K603||Anal fistula, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Sesame salt - Papaya latex Siddha Karanool therapy |
Siddha medicated thread used in the management of Anal fistula. Sesame salt, Papain powder of papaya latex and Turmeric coated Seton will be inserted through the fistulous tract and ligated externally and this medicated thread will be changed weekly once until the infection is burnt out. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with pain and discharge continuously or intermittently
Fistula in ano patients having single tract of length less than 8 cm without abscess (St. James University Hospital MRI Classification of Anal fistula – grade I)
|
|
| ExclusionCriteria |
| Details |
Crohn’s disease
Ulcerative colitis
Urogenital tuberculosis
Uncontrolled metabolic disorders
Intra-abdominal abscess
Intestinal and pelvic malignancies
Infection of pelvic bones
Venereal diseases, STD/HIV
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The temporal difference in PDAI scoring in perianal fistula from baseline to healed status will be described.
As its a pilot clinical trial, Sample size has been chosen as per ICMR guidelines. |
At baseline, weekly assessments, at endpoint |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Efficacy of Sesame Karanool therapy in perianal fistula will be documented.
Improvement in the Quality of Life of the patient with anal fistula from baseline to endpoint will be measured using QOLAF-Q.
Impact of duration of the fistula and tract length over the unique healing time of each patient will be described. |
Weakly assessments till the healing of fistula |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 |
|
Date of First Enrollment (India)
|
17/02/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Anal Fistula is one among the most commonly occurring anorectal diseases
with ICD-11- DB50.1, here the chronic granulating track runs from anal canal or
rectum to perineum or perianal skin. Anal fistula is an
epithelialized connection between the anal canal and perianal area externally.
It is characterized by inflammatory and granulation tissues with tenacious infection. Till date, surgery is the mainstay of treatment worldwide for anal fistula, but with sizeable percentage of recurrences. There is no simple
technique that can completely eliminate the infection and heal various kinds of anal fistula. Hence, an alternate method of management is needed to institute a complete cure by permanently eliminating the infection. Phyto-salt of Sesame (Elluppu), papain powder of papaya latex and turmeric will be used for preparing
Karanool (medicated thread) that would be used as seton to drain and burn the infection. The patients will be followed till their healed status and post-treatment for 5 years to declare the possible cured status. |