| CTRI Number |
CTRI/2024/12/078319 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
07/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
STUDY OF KARCHURA TAILA IN NADIVRANA |
|
Scientific Title of Study
|
RANDOMIZED CONTROL CLINICAL TRIAL OF KARCHURA TAILA IN
NADIVRANA WITH SPECIAL REFERENCE TO 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 Akash Chavan |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center |
| Address |
OPD NO.13 Shalya Tantra Department Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta Tal Walwa Dist Sangli Maharashtra 416301 India
Sangli
MAHARASHTRA
416301
India |
| Phone |
8862015352 |
| Fax |
|
| Email |
aakashvilas2211@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Jadhav |
| Designation |
Reader |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center |
| Address |
OPD No 13 Department of Shalya Tantra Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta Tal Walwa Dist Sangli Maharashtra 416301 India
Sangli
MAHARASHTRA
416301
India |
| Phone |
9823279290 |
| Fax |
|
| Email |
sjadhav21066@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil Jadhav |
| Designation |
Reader |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center |
| Address |
OPD No 13 Department of Shalya Tantra Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta Tal Walwa Dist Sangli Maharashtra 416301 India
Sangli
MAHARASHTRA
416301
India |
| Phone |
9823279290 |
| Fax |
|
| Email |
sjadhav21066@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta Tal walva Dist Sangli State Maharashtra Country India 416301 |
|
|
Primary Sponsor
|
| Name |
Hon shri Annasaheb Dange Ayurved Medical College Post graduate and research center Ashta |
| Address |
Hon shri Annasaheb Dange Ayurved Medical College Post
graduate and research center Ashta Tal Walwa Dist Sangli State Maharashtra Country India Pin code
416301 |
| Type of Sponsor |
Private medical 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 Akash Vilas Chavan |
Hon Shri Annasaheb Dange Ayurved Medical COllege Post Graduate And Research Center Ashta |
OPD No 13 Department Of Shalya Tantra Hon Shri Annasaheb Dange Ayurved Medical COllege Post Graduate And Research Center Ashta 416301
Sangli
MAHARASHTRA |
8862015352
aakashvilas2211@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Of Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Research Center Ashta Sangli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: NADIVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Karchura taila, Reference: Bhavaprakash and Bhaishajya Ratnavali , Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: 5% w/v Oily Phenol Injection, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients presenting with classical signs and symptoms of nadivarana with external opening on the body surface will be selected
2.patients having sinus due to acute infection mild infected wound and abscess
3.sinus tract lenght upto 5cms
4.patients selected irrespective of gender religion marital status |
|
| ExclusionCriteria |
| Details |
1.Congenital sinuses
2.Nadivrana with systemic disease like Diabetes mellitus Bleeding disorders AIDS
3. Osteomylitis followed by sinus
4.Patients having complicated sinuses due to chronic infections such as tuberculosis, actinomycosis etc
5.Patients having neoplastic sinus
6.If the sinus tract length is more than 5 cm |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Karchura Taila is effective in the management of Nadivrana |
15 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 5% w/v oily phenol injection in the management of Nadivrana |
15 Days |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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
|
Nadivrana is formed due to vranashopha is
not timely treated in pakvavastha or inadequately drained the pus, invades
deeper and deeper into the tissues in the form of a tube.The pus of an abscess
or swelling burrows into the affected part if a person neglect it in its fully
suppurated stage, and then the pus has been entered into deeper tissues and
penetrates inside and results into Nadivrana.A sinus is a blind ending tract leading from surface
down into the tissue and lines either by granulation tissue or by epithelium.
The incidence of the disease is calculated
to be 26 per 100,000 people. It occurs 2.2 times more often in male than in
female.
Karchura Taila application is one of which does not require anesthesia and having
good curative properties with worth full results. Karchura Taila has ropan(
healing) properties, thus help in treating Nadivrana effectively
Study time -15 days
Route-Local application and Puran
Dose-As Per Required (Approx.1-2ml) |