| CTRI Number |
CTRI/2024/07/069952 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Reduction of microbial load in chronic leg ulcer using nirgundi pathra arka as topical application |
|
Scientific Title of Study
|
Antimicrobial effect of Nirgundi pathra arka against Triphala kwatha in chronic leg ulcer |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhija T |
| Designation |
PG Scholar |
| Affiliation |
Govt ayurveda college tripunithura |
| Address |
Department of Salyatantra
Govt.Ayurveda college
Tripunithura
Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
9946384034 |
| Fax |
|
| Email |
drabhijajithudeepak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M S Shafeer |
| Designation |
Assistant Professor |
| Affiliation |
Govt ayurveda college Tripunithura Ernakulam |
| Address |
Department of Salyatantra
Govt Ayurveda college
Tripunithura
Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
9447524691 |
| Fax |
|
| Email |
shafeermudavankattil@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr M S Shafeer |
| Designation |
Assistant Professor |
| Affiliation |
Govt ayurveda college Tripunithura Ernakulam |
| Address |
Department of Salyatantra
Govt Ayurveda college
Tripunithura
Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
9447524691 |
| Fax |
|
| Email |
shafeermudavankattil@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Government ayurveda college Tripunithura Ernakulam
Pin no 682301
Kerala
India |
|
|
Primary Sponsor
|
| Name |
Dr Abhija T |
| Address |
Dep of salyatantra
Govt ayurveda college
Tripunithura
Ernakulam |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrAbhija T |
Government ayurveda college Tripunithura |
Department of salyatantra
Minor opertion theatre
Third floor
Government ayurveda college
Tripunithura
Ernakulam 682301
Ernakulam
KERALA |
9946384034
drabhijajithudeepak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional committee for ethics in research Government ayurveda college Tripunithura |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L978||Non-pressure chronic ulcer of other part of lower leg. Ayurveda Condition: VRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | vraNasyaShaShTi-upakramAH, वà¥à¤°à¤£à¤¸à¥à¤¯à¤·à¤·à¥à¤Ÿà¤¿-उपकà¥à¤°à¤®à¤¾à¤ƒ | (Procedure Reference: susrutha samhitha and arkaprakasha, Procedure details: based on sodhana with kashaya mentioned in shashti upakrama
cleaning and dressing with arka for 7 days.observed 1/2hr and redressed with sterile gauze pad each day. )
| | 2 | Comparator Arm | Procedure | - | vraNasyaShaShTi-upakramAH, वà¥à¤°à¤£à¤¸à¥à¤¯à¤·à¤·à¥à¤Ÿà¤¿-उपकà¥à¤°à¤®à¤¾à¤ƒ | (Procedure Reference: susrutha samhitha and arkaprakasa, Procedure details: triphala kwatha kshalana and dressing done for 7 days.
based on sodhana with kashaya in shashti upakrama)
|
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
with slough and discharge
irrespective of gender
with informed consent |
|
| ExclusionCriteria |
| Details |
ulcer size above 10cm length and breadth
h/omalignancy burns TB
arterial ulcer osteomyelitic sinus
with poor diabetic control |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the antimicrobial effect of nirgundi pathra arka and triphala kwatha in chronic leg ulcers by assessing the microbial load |
zero and eight day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the effect of nirgundi pathra arka and triphala kwatha in pain discharge odour and floor of ulcer |
0th 4th 8th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/07/2024 |
| 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 topical application of nirgundi pathra arka and triphala kwatha in chronic leg ulcer and to compare the anti microbial effect of the drugs. nirgundi pathra arka is prepared from vitex negundo leaves triphala kwatha prepared from hareethaki ,vibheethaki and amlaki. each groups are advised to do kshalana with arka and triphalakwatha respectively,dressed with the same and observed for 1/2hr . dressing changed and re dressed with sterile gauze pad. assessement is done with microbial load as primary objective on 0th and 8th day assessement of pain discharge odour floor of the ulcer in 0th 4th 8th days pain assessed by vas scale.others are assessed by grading |