| CTRI Number |
CTRI/2020/01/022960 [Registered on: 27/01/2020] Trial Registered Prospectively |
| Last Modified On: |
19/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
Role of Kaarathiri and Kuppaimeni thippili chooranam in the management of Pauthiram |
|
Scientific Title of Study
|
A clinical study on the role of kaarathiri(externally) and kuppaimeni thippili chooranam (internally) 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 Kavitha G |
| Designation |
PG Scholar |
| Affiliation |
National institute of siddha |
| Address |
Room no:3, Department of Pura Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Kancheepuram
-do-
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
7092928621 |
| Fax |
22381314 |
| Email |
thirukavig1629@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Samundeswari |
| Designation |
Lecturer |
| Affiliation |
National Institute of iddha |
| Address |
Room no:3, Department of Pura Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Kancheepuram
-do-
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9445403599 |
| Fax |
22381314 |
| Email |
mdsamuk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavitha G |
| Designation |
PG Scholar |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
Room no:3, Department of Pura Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Kancheepuram
Room no:3, Department of Pura Maruthuvam, National Institute of Siddha, Tambaram Sanatorium,
Kancheepuram
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
7092928621 |
| Fax |
22381314 |
| Email |
thirukavig1629@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No:3 Ayothidoss Pandithar Hospital,
National Institute Of Siddha,
Tambaram Sanatorium, Chennai-47
|
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Ayothidoss Pandithar Hospital,
National Institute of Siddha,
Tambaram Sanatorium |
| 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 Kavitha G |
Ayothidoss Pandithar Hospital |
Room No:3, Department of Pura Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Kancheepuram
Kancheepuram
TAMIL NADU |
7092928621
22381314
thirukavig1629@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: K60||Fissure and fistula of anal and rectal regions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kuppaimeni thippili chooranam as internal medicine
Kaarathiri as external medicine
|
Kuppaimeni thippili chooranam as internal medicine - 1 gm bd with ghee. Kaarathiri is used as external medicine for two days once. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Pus, blood and watery discharge from perianal and anal region
2.Fistula tract within 3 cm
3.Patients who are willing to undergo kaarathiri therapy
4.Those who are willing to give specimen of blood for investigation whenever required.
5.Those who are willing to attend OPD or admission in IPD for 3 months
6.Willing to take photograph before and after treatment.
&.Patient already presenting with MRI fistulagram are willing to get the same from recognized laboratory. |
|
| ExclusionCriteria |
| Details |
Tuberculosis(genito urinary tract)
Hepatitis B,C
Hemophilia and bleeding disorder
Sexually transmitted diseases
Coronary heart disease and other heart ailments
Uncontrolled diabetes
Rectal prolapse and carcinoma
High anal fistula and complicated fistula
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The measurement of the length of the tract will assessed by probe.
2. Reduction in pain, pus discharge, burning sensation, itching around the anus will be assessed by Perianal Disease Activity Index(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)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
30/01/2020 |
| 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="0"
Months="3"
Days="0" |
|
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)?
|
|
Brief Summary
|
It is an interventional study in which the patient will be selected based on inclusion and exclusion criteria. After enrolling the patient into the study the trial drug Kuppaimeni thippili chooranam 2g bd with ghee along with the Kaarathiri as external medicine will be given to the patient. At the end of the study, the tract length will be assessed by probe. Reduction in pain pus discharge, burning sensation, itching around the anus, will be assessed by Perianal Disease Activity Index (PDAI).
|