| CTRI Number |
CTRI/2024/09/074403 [Registered on: 26/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison with vibhitaki kshara sutra against apamarga kshara sutra in pilonidal sinus |
|
Scientific Title of Study
|
A comparative study on the effectiveness of vibhitaki kshara sutra against apamarga kshara sutra in pilonidal sinus |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Roshini R |
| Designation |
First year PG scholar |
| Affiliation |
Government ayurveda college Thiruvananthapuram kerala |
| Address |
Department of salyatantra
Government Ayurveda college
Thiruvananthapuram
kerala
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9562404343 |
| Fax |
|
| Email |
roshinir633@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Remya V R |
| Designation |
Assistant professor |
| Affiliation |
Government Ayurveda college Thiruvananthapuram |
| Address |
Department of salyatantra
Government ayurveda college
Thiruvananthapuram
kerala
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9947035121 |
| Fax |
|
| Email |
remyarenjith3784@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roshini R |
| Designation |
First year PG scholar |
| Affiliation |
Government Ayurveda college Thiruvananthapuram |
| Address |
Department of salyatantra
Government Ayurveda college
Thiruvananthapuram
kerala
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9562404343 |
| Fax |
|
| Email |
roshinir633@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government ayurveda college
Thiruvananthapuram kerala India
pin 695001 |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda college |
| Address |
Government ayurveda college
Thiruvananthapuram
kerala
India
695001 |
| Type of Sponsor |
Other [Government ayurveda college] |
|
|
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 Roshini R |
Government ayurveda college |
Department of salyatantra OP division room no 3 Thiruvananthapuram
695001
kerala
Thiruvananthapuram
KERALA |
9562404343
roshinir633@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Government ayurveda college Thiruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L05||Pilonidal cyst and sinus. Ayurveda Condition: NADIVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: susrutha samhitha, Procedure details: Painting & draping will be done. Local anesthesia will be performed by injecting lignocaine hydrochloride 2% until the patient is properly anesthetized. Under aseptic precaution copper malleable probe will be introduced through the external opening & then taken out through the other end (incised blind end ) & Vibhithaki kshara sutra will be applied. Two ends of the kshara sutra will be tied. Blood clots will be
removed & cleaned. Then packed with sterile surgical pad. On every subsequent 7th day, rethreading using Vibhithaki sootra will be done until the track is completely cut through. New thread will be tied on either side of the old knot & thread will be changed by railroad technique. The old thread will be cut off & its length will be measured & recorded in the proforma .Total time depends on the length of the tract (till the wound heals completely))
| | 2 | Comparator Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: susrutha samhitha, Procedure details: Painting & draping will be done. Local anesthesia will be performed by injecting lignocaine hydrochloride 2% until the patient is properly anesthetized. Under aseptic precaution copper malleable probe will be introduced through the external opening & then taken out through the other end (incised blind end ) apamarga kshara sutra will be applied. Two ends of the kshara sutra will be tied. Blood clots will be
removed & cleaned.On every subsequent 7th day, rethreading using apamarga kshara sutra will be done until the track is completely cut through. New thread will be tied on either side of the old knot & thread will be changed by railroad technique. The old thread will be cut off & its length will be measured & recorded in the proforma .Total time depends on the length of the tract)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Subjects having clinical features of Pilonidal sinus.
Age group 18-50 years.
Subjects will be selected irrespective of gender, religion, caste and economic status.
Subjects with informed consent |
|
| ExclusionCriteria |
| Details |
Subjects with uncontrolled Diabetes Mellitus Subjects with known cases of major cardiac illness
Subjects with known cases of Bleeding disorder |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the cutting and healing effect kshara sutra
in pilonidal sinus.
|
Assessment will be done on 0th day and every 7th day after Ksharasutra application till cut through of the tract.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the pain (by VAS)and discharge(by grading) |
Assessment will be done on 0th day and every 7th day after Ksharasutra application till cut through of the tract |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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
|
N/A |
|
Date of First Enrollment (India)
|
28/10/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The above study deals with comparing the effectiveness of vibitaki ksharasutra against apamarga kshara sutra in pilonidal sinus by assessing the healing and cutting effect by UCT and pain by VAS ,discharge by grading .various clinical studies have proved significant effect of ksharasutra in pilonidal sinus .present study has been undertaken to evaluate the effectiveness of vibhitaki kshara sutra against apamarga kshara sutra in pilonidal sinus. Apamarga is widely used in pilonidal sinus , now the study is to compare the effectiveness of vibhitaki against apamarga in pilonidal sinus
|