| CTRI Number |
CTRI/2020/01/022751 [Registered on: 14/01/2020] Trial Registered Prospectively |
| Last Modified On: |
13/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
Efficacy of Sindhu valladhi and Arayappu kattiku Kalimbu in Aasana Pavuththiram patients |
|
Scientific Title of Study
|
Evaluation of therapeutic efficacy of "Sindhu Valladhi"(Internal medicine) and Arayappu Kattiku Kalimbu"(External medicine) in "Aasana Pavuththiram(Fistula in Ano) patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yogalakshmi G |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room No:1,Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Kancheepuram
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8838239321 |
| Fax |
22381314 |
| Email |
drgyoga2521@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H Nalini Sofia |
| Designation |
Lecturer |
| Affiliation |
National Institute of Siddha |
| Address |
Room No:1,Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Kancheepuram
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8939899363 |
| Fax |
22381314 |
| Email |
dr.h.nalinisofia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Yogalakshmi |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room No:1,Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Kancheepuram
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8838239321 |
| Fax |
22381314 |
| Email |
drgyoga2521@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss Pandithar Hospital,National Institute Siddha,Tambaram Sanatorium |
|
|
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 G Yogalakshmi |
Ayothidoss Pandithar Hospital |
Room No:1, Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium
Kancheepuram
TAMIL NADU |
8838239321
22381314
drgyoga2521@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 |
Sindhu valladhi(Internal medicine)
Arayappu Kattiku kalimbu(External Medicine) |
Internal Medicine:Sindhu Valladhi
Dose:0.798 gm
Days:45 Days
External Medicine:Arayappu Kattiku Kalimbu
Dose:Required quantity for external application |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Pain in Ano rectal region(Throbbing pain),
Faeces with blood,
External opening in peri anal and perineal region that can be probed,
Discharge of pus or blood in peri anal region,
Low anal fistula confirmed by probing and MRI Fistulogram,
Uncomplicated Fistula from Grade I to Grade III(St. James University Classification of Peri anal fistula)
Tract length upto 4 cm,
Patient who are willing to give consent. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Clinical symptoms will be done by Peri Anal Disease Activity Index |
Forty Sixth Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Labortaory investigations such as CBC,LFT,RFT,Urine routine,MRI Fistulogram will also be done at the end of study |
Forty Sixth Day |
|
|
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 3 |
|
Date of First Enrollment (India)
|
15/01/2020 |
| 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="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET |
|
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 20 participants will be selected based on Inclusion and Exclusion criteria. After enrolling the patient in study, Internal medicine-Sindhu Valladhi 0.798gm will be given twice a day for the period of 45 days and dressing will be done using Arayappu Kattiku Kalimbu once in two days for the period of 45 days. After completion of study prognosis will be assessed by using Peri Anal Disease Activity Index. |