| CTRI Number |
CTRI/2022/07/044467 [Registered on: 29/07/2022] Trial Registered Prospectively |
| Last Modified On: |
26/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
kaathiri for pauthiram(fistula in ano) |
|
Scientific Title of Study
|
AN OPEN, NON-RANDOMIZED, SINGLE ARM, SINGLE CENTRIC CLINICAL TRIAL TO DETERMINE THE THERAPEUTIC EFFICACY OF KAARATHIRI IN THE MANAGEMENT OF PAUTHIRAM (FISTULA IN ANO) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramya V |
| Designation |
PG Scholar |
| Affiliation |
National institute of Siddha |
| Address |
Room no 3p,
Department of Pura Maruthuvam,
National institute of Siddha,
Tambaram sanatorium,
Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
7708604896 |
| Fax |
22381314 |
| Email |
ramyapadma3697@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Muthukumar N J |
| Designation |
Professor |
| Affiliation |
National institute of Siddha |
| Address |
Room no 3p,
Department of Pura Maruthuvam,
National institute of Siddha,
Tambaram sanatorium,
Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444206843 |
| Fax |
22381314 |
| Email |
njmuthukumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Muthukumar N J |
| Designation |
Professor |
| Affiliation |
National institute of Siddha |
| Address |
Room no 3p,
Department of Pura Maruthuvam,
National institute of Siddha,
Tambaram sanatorium,
Chennai
TAMIL NADU
600047
India |
| Phone |
9444206843 |
| Fax |
22381314 |
| Email |
njmuthukumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss Pandidhar Hospital,
National institute of Siddha,
Tambaram sanatorium,
Chennai |
|
|
Primary Sponsor
|
| Name |
National institute of Siddha |
| Address |
Ayothidoss Pandidhar Hospital,
National institute of Siddha,
Tambaram sanatorium,
Chennai |
| 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 Ramya V |
Ayothidoss Pandithar Hospital |
Room no 3p,
Department of Pura Maruthuvam,
National institute of Siddha,
Tambaram sanatorium,
Chennai
Kancheepuram
TAMIL NADU |
7708604896
22381314
ramyapadma3697@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
| Intervention |
Kaarathiri |
Kaarathiri for Pauthiram with the treatment period of 3 months 2 days once |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age: 18 to 60 years.
Patients having the clinical features of the following Pus and or blood discharge, discharge from perianal and anal region.
Sex: Male, Female and Transgender.
Fistula tract within 4 cm.
Patient who are willing to undergo Kaarathiri therapy.
Willing to give specimen of blood for investigation whenever required.
Willing to attend OPD or admission in IPD for 3 months.
Willing to take photograph before and after treatment
Patient willing to take MRI
|
|
| ExclusionCriteria |
| Details |
Tuberculosis (Genito urinary tract).
Hepatitis B & C.
H/o Haemophilia and bleeding disorders.
Pregnancy & Lactation.
Uncontrolled diabetes
H/o Coronary Heart Diseases and other cardiac ailments.
AIDS, Syphilis.
H/o Crohn’s disease.
High anal fistula and complicated fistula
Rectal prolapse
H/o rectal carcinoma.
Not willing to take Investigations..
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
outcome of the study will be measured by Reduction in pain, pus discharge, burning sensation, itching around the anus well be accessed by Perianal Disease Activity Index (PDAI).
|
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2022 |
| Date of Study Completion (India) |
20/08/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is an open, non - randomized, single arm, single centric trial to determine the therapeutic efficacy of kaarathiri in the management of pauthiram (Fistula in ano) recurrent anal abscess, pain and swelling around the anus, pain with bowel movements, bloody or foul-smelling drainage (pus) from an opening around the anus will be enrolled based on the inclusion and exclusion criteria. After enrolling the patients in the study, the treatment will be given with kaarathiri- 3 months 2 days once. After the 3 months the reduction in symptoms will be assessed by Perianal Disease Activity Index (PDAI). |