| CTRI Number |
CTRI/2024/12/077868 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
26/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TO STUDY THE EFFECT OF NIRGUNDI TAIL IN POST OPERATIVE INFECTED WOUND. |
|
Scientific Title of Study
|
RANDOMISED CONTROLLED CLINICAL TRIAL OF NIRGUNDI TAIL AS SHODHAN & ROPAN IN THE MANAGEMENT OF SHASTRAKARMOTTAR DUSHTA VRAN W.S.R. TO SURGICAL SITE INFECTION. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sumaiya faruque sheikh |
| Designation |
PG Scholar |
| Affiliation |
CSMSS ayurved mahavidyalaya, kanchanwadi chh sambhaji nagar |
| Address |
CSMSS Ayurved Hospital Shalya Tantra Department kanchanwadi Aurangabad. MAHARASHTRA
431002
Aurangabad
MAHARASHTRA
431002
India |
| Phone |
8806092682 |
| Fax |
|
| Email |
sumaiyas001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gadve B N |
| Designation |
HOD of Shalya tantra department |
| Affiliation |
CSMSS Ayurved Hospital |
| Address |
CSMSS Ayurved Hospital Shalya Tantra Department kanchanwadi Aurangabad. MAHARASHTRA
431002
Aurangabad
MAHARASHTRA
431002
India |
| Phone |
9822682898 |
| Fax |
|
| Email |
drgadvekayakalp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gadve B N |
| Designation |
HOD of Shalya tantra department |
| Affiliation |
CSMSS Ayurved Hospital |
| Address |
CSMSS Ayurved Hospital Shalya Tantra Department kanchanwadi Aurangabad. MAHARASHTRA
431002
Aurangabad
MAHARASHTRA
431002
India |
| Phone |
9822682898 |
| Fax |
|
| Email |
drgadvekayakalp@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSMSS ayurved hospital shalya Tantra department kanchanwadi chh sambhaji nagar,431002, Maharashtra,India |
|
|
Primary Sponsor
|
| Name |
Sumaiya faruque sheikh |
| Address |
CSMSS ayurved hospital shalya Tantra department kanchanwadi chh sambhaji nagar,431002, Maharashtra,India |
| 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 |
| Drsumaiya sheikh |
CSMSS Ayurved College And Hospital Kanchanwadi |
Shalya tantra OPD, room no 16
Aurangabad
MAHARASHTRA |
8806092682
sumaiyas001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CSMSS Ayurved College And Hospital Kanchanwadi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B999||Unspecified infectious disease. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nirgundi Taila, Reference: Chakradatta, Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jatayadi taila, Reference: Bhaishajya Ratnawali, Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients having Surgical Site Infection irrespective of gender, occupation, economic & social status.
2) Post-operative patients of Fissure-in-ano, Fistula-in-ano, Hemorrhoids, Pilonidal sinus, Abscess, Lipoma.
3) Surgical Site Infection having dimension up to 16cm.2
4) Patient ready to give written consent will be selected.
5) Patients of age group 18-70 yrs. |
|
| ExclusionCriteria |
| Details |
1) Surgical Site Infection of patient having malnutrition, diabetes, uremia, jaundice.
2) Patient is suffering from HIV and HBsAg.
3) Wound size more than 16 cm².
4) Patients of age group below 18yrs and above 70yrs
5) K/C/O/ Anemia. (Hb % ≤8).
6) Patients having septicemia.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wound Healed |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| efficacy of jatyadi tail |
28days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
15/12/2024 |
| 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 Applicable |
| 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
|
This study is randomised clinical open trial to see the effect of nirgundi taila in shastrakarmottar dushta vrana upto 16 cm.sq. patient having age 18 to 70 yr without any co-morbidity with randomly selection and willing for procedure.primary outcome of trial will be healed wound within less than 28 days |