| CTRI Number |
CTRI/2022/10/046913 [Registered on: 31/10/2022] Trial Registered Prospectively |
| Last Modified On: |
27/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical evaluation of siddha formulation Koozhpaanda chooranam (internal) and Powthira Ranangalukku kalimbu (external) in the management of Paganthara moolam (fistula in ano) |
|
Scientific Title of Study
|
An open, non – randomised, single arm, phase II, single centric clinical trial to evaluate the effectiveness of Siddha formulation Koozhpaanda chooranam (internal) and Powthira ranangalukku kalimbu (external) in the management of Paganthara moolam (Fistula in- Ano) among patients attending Ayothidoss pandithar hospital, National Institute of Siddha. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRMOHANA |
| Designation |
PG SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
DEPARTMENT OF MARUTHUVAM NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
KANCHEEPURAM DIST
TAMILNADU
INDIA
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8508439127 |
| Fax |
044-22381314 |
| Email |
rmohana796@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrHVETHA MERLIN KUMARI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
DEPARTMENT OF MARUTHUVAM NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
KANCHEEPURAM DIST
TAMILNADU
INDIA
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9894782366 |
| Fax |
044-22381314 |
| Email |
dr.vetha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRMOHANA |
| Designation |
PG SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
DEPARTMENT OF MARUTHUVAM NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
KANCHEEPURAM DIST
TAMILNADU
INDIA
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8508439127 |
| Fax |
044-22381314 |
| Email |
rmohana796@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Maruthuvam
Ayothidoss pandithar hospital
National institute of siddha
Tambaram sanatorium
Chennai-47 |
|
|
Primary Sponsor
|
| Name |
National institute of Siddha |
| Address |
National institute of siddha
Tambaram sanatorium
Chennai-47 |
| 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 |
| DrR MOHANA |
Ayothidoss pandithar hospital |
Department of Maruthuvam
Ayothidoss pandithar hospital
National Institute of Siddha
Tambaram sanatorium
Chennai-47
Kancheepuram
TAMIL NADU |
8508439127
044-22381314
rmohana796@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K605||Anorectal fistula. Ayurveda Condition: nil, (2) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Koozhpaanda chooranam(internal)
Powthira ranangalukku kalimbu(external) |
1.Koozhpaanda chooranam 1 gram with hot water twice a day
2.Powthira ranangalukku kalimbu external for 48 days
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age: 20 to 60 years
2.Pus, blood and watery discharge from perianal and anal region
3.Sex: Male, Female and Transgender
4.Fistula tract within 4 cm
5.Patient who are willing to undergo kaaraseelai therapy
6.Willing to give specimen of blood for investigation whenever required
7.Willing to attend OPD or admission in IPD
8.Willing to take photograph before and after treatment
9.Patient already presenting with MRI fistulogram or willing to get the MRI from recognized laboratory
|
|
| ExclusionCriteria |
| Details |
1.Tuberculosis (Genito urinary tract).
2.Hepatitis B & C.
3.Hemophilia and bleeding disorders.
4.Pregnancy & Lactation.
5.Uncontrolled diabetes.
6.K/H/O Cardio vascular Diseases.
7.AIDS, Syphilis.
8.K/H/O Crohn’s disease.
9.High anal fistula and complicated fistula.
10.Rectal prolapse.
11.K/H/O Rectal carcinoma.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The measurement of the tract length before and after treatment will be assessed by PDAI and good outcome of PDAI score becoming zero. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| secondary outcome is assessed by unit cutting time |
1 year |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
04/11/2022 |
| 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="1"
Months="2"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an open non-Randomised clinical trial that evaluates therapeutic effectiveness of siddha formulation KOOZHPAANDA CHOORANAM
(INTERNAL) and POWTHIRA RANANGALUKKU KAZHIMBU (EXTERNAL) in the management of PAGANTHARA MOOLAM (FISTULA- IN ANO) patients through
MRI- Fistulogram) before
treatment and Perianal Disease Activity Index
(PDAI) before and aftertreatment.
Fistula in-ano is the second most prevalent anorectal disorder after
hemorrhoids. According to Park’s classification it classified into 4 types
(Inter-sphincteric, Trans-sphincteric, Supra-sphincteric, Extra-sphincteric).
The causes for fistula in ano are cryptoglandular (90%), non-cryptoglandular
(10%). The cryptoglandular infection in anal region that causes abscess and pus
and mucous discharge draining from external opening through fistula track. The
symptoms are recurrent anal abscess, pain and swelling around anal region,
bloody or foul- smell drainage (pus) from an opening around the anus, pain with
bowel movement. So, my aim is to
treat the Paganthara Moolam (fistula- in ano) with the Siddha formulation KOOZHPAANDA
CHOORANAM (INTERNAL) and POWTHIRA RANANGALUKKU KAZHIMBU (EXTERNAL).
MATERIALS AND METHODS:
A Total of 20 diagnosed
patients of Paganthara moolam (fistula- in ano) within the age limit of 20 -60
years willing to participate in the study,
by signing the consent form will be enrolled in the study. Tuberculosis (Genito
urinary tract), Hepatitis B & C, Hemophilia and bleeding disorder,
Pregnancy & Lactation, Uncontrolled Diabetes, Coronary Heart Disease, AIDS
& Syphilis, Crohn’s disease, High anal fistula and complicated fistula,
Rectal prolapse, Rectal carcinoma will be excluded. Assessment in improvement is done through
Perianal Disease Activity Index (PDAI) before and aftertreatment.
|