| CTRI Number |
CTRI/2023/08/056066 [Registered on: 03/08/2023] Trial Registered Prospectively |
| Last Modified On: |
24/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pun sudar thyla thiri for Pouthiram (Fistula in ano) |
|
Scientific Title of Study
|
AN OPEN SINGLE ARM SINGLE CENTRIC CLINICAL TRIAL TO DETERMINE THE THERAPEUTIC EFFECTIVENESS OF PUN SUDAR THYLA THIRI IN THE MANAGEMENT OF POUTHIRAM (FISTULA IN ANO) |
| Trial Acronym |
PSTT for Pouthiram |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SANJANA S |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room.NO: 14
Department of Pura Maruthuvam
National Institute of Sidddha
Tambaram sanatorium
Chennai
Kancheepuram
TAMIL NADU
600 047
India |
| Phone |
7904237083 |
| Fax |
|
| Email |
sanjanateddy16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MAHADEVAN M V |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room.NO: 14
Department of Pura Maruthuvam
National Institute of Sidddha
Tambaram sanatorium
Chennai
Kancheepuram
TAMIL NADU
600 047
India |
| Phone |
9840417565 |
| Fax |
|
| Email |
mvmsrmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MAHADEVAN M V |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room.NO: 14
Department of Pura Maruthuvam
National Institute of Sidddha
Tambaram sanatorium
Chennai
Kancheepuram
TAMIL NADU
600 047
India |
| Phone |
9840417565 |
| Fax |
|
| Email |
mvmsrmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss Pandithar Hospital
National Institute of Siddha
|
|
|
Primary Sponsor
|
| Name |
National Institute of SIddha |
| Address |
Ayothidoss Pandithar Hospital
National Institute of Siddha
Tambaram sanatorium
Chennai 600 047
|
| 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 SANJANA S |
Ayothidoss Pandithar Hospital National Institute of Siddha Tambaram sanatorium Chennai 600 047. |
Room. No: 14
Department of Pura Maruthuvam
National Institute of Siddha
Chennai 600 047
Kancheepuram
TAMIL NADU |
7904237083
sanjanateddy16@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: K605||Anorectal fistula, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Pun sudar thyla thiri |
Pun sudar thyla thiri for pouthiram with the treatment period of 3 months 2 days once |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age: 18 to 60 years.
2.Patients having the clinical features of the following
Pain and swelling in the perianal region
Pus and or blood discharge from perianal and anal region.
Skin irritation.
Perianal abscess.
3.Sex: Male, Female and Transgender.
4.Fistula tract length within 4 cm.
5.According to St James University Hospital Classification, Grade I and II will be included.
6.Patient who are willing to undergo Kaarathiri therapy.
7.Willing to give specimen of blood for investigation whenever required.
8.Willing to attend OPD or admission in IPD if necessary.
9.Willing to take photograph of the tract before and after treatment
10.Willing to take MRI
|
|
| ExclusionCriteria |
| Details |
1.K/c/o Tuberculosis
2.K/c/o Hepatitis B & C.
3.K/c/o Haemophilia and bleeding disorders.
4.H/o Pregnancy & Lactation.
5.The patient who has uncontrolled diabetes (HbA1C more than 7.6) will be treated for diabetes and after the confirmation of good control he/she will be included for this study.
6.K/c/o coronary heart diseases and other cardiac ailments.
7.K/c/o AIDS, Syphilis.
8.K/c/o Crohn’s disease.
9.K/c/o High anal fistula and complicated fistula
10.K/c/o Rectal prolapse
11.K/c/o Rectal carcinoma.
12.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 |
| The 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 Score (PDAI). |
3 MONTHS |
|
|
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)
|
10/08/2023 |
| Date of Study Completion (India) |
15/02/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is an an open single arm single centric clinical trial to determine the therapeutic effectiveness of Pun sudar thyla thiri in the management of Pouthiram (Fistula in Ano). The clinical signs and symptoms are recurrent anal abscess, pain and swelling around the anus, pain with bowel movements, bloody or foul smelling, pus/blood discharge from opening around the anus will be enrolled based on the inclusion and exclusion criteria. After enrolling the patients in the study, the treament will be given for 3 months 2 days once. After 3 months the reduction in symptoms will be assessed by Perianal Disease Activity Index (PDAI). |