| CTRI Number |
CTRI/2025/08/092414 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Trial to study the Effect of Kankshi jala prakshalana in the patients with Dushtavrana. |
|
Scientific Title of Study
|
An Open Label Single Arm Clinical Study to Evaluate the effect of Kankshi Jala Prakshalana in Dushtavrana |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrShrikanth Karjagi |
| Designation |
PG Scholar |
| Affiliation |
Ashwini Ayurvedic medicaal college and Research Center, Marluru ring road, Tumkur 572105, Karnataka |
| Address |
Shalyatantra Department, OPD no. 11, Ashwini Ayurvedic medicaal college and Research Center, Marluru ring road, Tumkur 572105, Karnataka Ashwini Ayurvedic medicaal college and Research Center, Marluru ring road, Tumkur 572105, Karnataka Tumkur KARNATAKA 572105 India |
| Phone |
8660703292 |
| Fax |
|
| Email |
shrikanthkarjagi7@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrDharmapal S L |
| Designation |
HOD and Professor |
| Affiliation |
Ashwini Ayurvedic medicaal college and Research Center, Marluru ring road, Tumkur 572105, Karnataka |
| Address |
Shalyatantra Department, OPD no.11, Ashwini Ayurvedic medical College and Research centre, Marluru ring road, Tumkur -572105
Tumkur KARNATAKA 572105 India |
| Phone |
9916121607 |
| Fax |
|
| Email |
drdharmapal@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shrikant karjagi |
| Designation |
PG Scholar |
| Affiliation |
Ashwini Ayurvedic medicaal college and Research Center, Marluru ring road, Tumkur 572105, Karnataka |
| Address |
Shalyatantra Department,OPD no.11, Ashwini Ayurvedic Medical College and Research centre, Marluru Ring Road-572105
Tumkur KARNATAKA 572105 India |
| Phone |
9916121607 |
| Fax |
|
| Email |
shrikanthkarjagi7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ashwini Ayurvedic medicaal college and Research Center, Marluru ring road, Tumkur 572105, Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr.Shrikanth Karjagi |
| Address |
Shalyatantra Departement, OPD no.11,Ashwini Ayurvedic medicaal college and Research Center, Marluru ring road, Tumkur 572105, Karnataka |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DrDharmapal S L |
Ashwini Ayurvedic medicaal college and Research Center, Marluru ring road, Tumkur 572105, Karnataka |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrShrikanth Karjagi |
Ashwini Ayurvedic Medical College and Research centre |
Shalyatantra Department, OPD no.11,FGW-28-32, MGW-28-32,Ashwini Ayurvedic medicaal college and Research Center, Marluru ring road, Tumkur 572105, Karnataka Tumkur KARNATAKA |
8660703292
shrikanthkarjagi7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ashwini Ayurvedic Medical College institutional Ethical Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | _prakShAlana-karma, प्रक्षालन-कर्म | (Procedure Reference: Sushruta Samhita, Astanga Hridaya, Procedure details: A) POORVA KARMA Informed consent, Sangraha of Sambharadravya, Preparation of Kankshijala, Preparation of Nimbapatra kalka for Lepa, Preparation of patient-Ashvasana, explaining the procedure, positioning; Vrana exposed properly. B) PRADHANA KARMA Vrana Prakshalana with Kankshijala followed by Nimbapatra Lepa application. C) PASHCAT KARMA Sterile bandaging will be done. )
) (1) Medicine Name: Kankshi, Reference: Rasatarangini, Rasa ratna Samuchhaya, Ayurveda Prakash, Route: Topical, Dosage Form: Churna/ Powder, Dose: 1.25(g), Frequency: od, Duration: 10 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with ulcers presenting with Lakshanas of Dustavrana.
Subjects of Madhyama Vaya 26 that is aged between 16 years to 70 years.
Subjects will be selected irrespective of Gender, Religion, Occupation and Socio Economic Status.
|
|
| ExclusionCriteria |
| Details |
Subjects suffering from complicated systemic disorders that which interfere in the line of treatment.
Subjects of known cases like Malignancy, Gangrene, Leprosy, TB wound.
Subjects with known cases of HIV, Hepatitis-B.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reductiion in foul smell, Discharge
|
10 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Healing of Dustavrana |
10 days |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| 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="2" Days="4" |
|
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
|
Acharya Susruta has
emphasised Dushtavrana while
presenting the definition of Shalyatantra. “Vrana Gaatra Vichurnane Vranayateeti Vrana|” Vrana denotes wound, Gaatra denotes body tissue or part of the body, and Vichurnane denotes breakdown /
discontinuity / destruction / rupture. The prevalence
of the disease in an Indian epidemiological study states that, the chronic
ulcer has the prevalence rate of
4.5/1000 population.
Taking the Lakshana into
consideration Vrana can be classified into Shuddhavrana and
Dustavrana. Doshas and Dushyas that have accumulated
excessively and been vitiated transform Shuddhavrana into Dustavrana.The Dustavrana
has the clinical
features like excessive
discharge, foul smell, pain,
itching, delayed wound healing etc. A healthy wound in a
healthy body heals more quickly and
leaves fewer scars than a wound that has been contaminated. There are 4 phases of wound healing, however
prolonged cessation or slowdown of healing
in any one of these phases cause the wound to become chronic, which
can be correlated with Dustavrana that is delayed healing of the Vrana due to vitiated Dosha. Kankshi is
one of the Uparasa which is used for Shodhana and Ropana of the Vrana as
per Rasatarangini Rasaratnasamucchaya, and Ayurveda Prakasha.
Nimba is known for its Krimighna and also Vranagna property. Acharya Susruta has
specified Shasti Upakrama for Dustavrana, including Alepa,
Kashaya, Varti, kalka,
Taila, Rasakriya etc.
Among which Alepa is
the 2nd upakrama.
Acharya
Vargbhata, has mentioned
Prakshalana, Alepa, Ghrita, Taila, Rasakriya, Churna, and
Varti as the Dustavrana Saptavidha Chikitsa, of
which the first and second
upakramas are Prakshalana and
Alepa. Among various procedures
explained Prakshalana and Lepa
are economical, easy for the preparation, application and can be performed in
outpatient department. The non-healing ulcer generally generates
unpleasant symptoms which includes intense
pain, exudates, and malodour that can also disrupt day-to-day causing
social stigma. Thus, it is necessary to find
a solution to overcome these factors. Hence this is an attempt to methodically evaluate the impact
of Prakshalana by Kankshijala followed by
Nimbapatra lepa in Dustavrana. |