| CTRI Number |
CTRI/2025/10/096467 [Registered on: 24/10/2025] Trial Registered Prospectively |
| Last Modified On: |
24/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of Jalaukavcharan in management of Non healing ulcers |
|
Scientific Title of Study
|
Assessment of effect of Jalaukavcharan in management of Dushta vrana w.s.r.t. Non Healing Ulcers- Randomized control trial |
| 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 Renuka Ramakant Moharkar |
| Designation |
PG Scholar Shalyatantra department |
| Affiliation |
YMT Ayurveda Medical college and Hospital |
| Address |
Shalyatantra OPD no 4, YMT Ayurveda college and Hospital, sector 4, kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9767614009 |
| Fax |
|
| Email |
renukamoharkar8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. D D Chavan |
| Designation |
HOD And Associate Professor |
| Affiliation |
YMT Ayurveda Medical college and Hospital |
| Address |
Shalyatantra OPD no 4,YMT Ayurveda Medical College and hospital, sector 4, kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9822221585 |
| Fax |
|
| Email |
dnyanesh7373@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Renuka Ramakant Moharkar |
| Designation |
PG Scholar Shalyatantra department |
| Affiliation |
YMT Ayurveda Medical college and Hospital |
| Address |
Shalyatantra OPD no 4, YMT Ayurveda Medical college and Hospital, sector 4, kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9767614009 |
| Fax |
|
| Email |
renukamoharkar8@gmail.com |
|
|
Source of Monetary or Material Support
|
| YMT Ayurveda Medical college and Hospital, sector 4,kharghar, Navi Mumbai ,India 410210 |
|
|
Primary Sponsor
|
| Name |
Dr Renuka Ramakant Moharkar |
| Address |
Shalyatantra OPD no 4, YMT Ayurveda Medical college and Hospital, sector 4,kharghar, Navi Mumbai |
| Type of Sponsor |
Other [Self funding] |
|
|
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 Renuka Moharkar |
YMT Ayurvedic Medical College and Hospital |
Shalyatantra OPD no 4, YMT Ayurved medical college and hospital, Sector 4, Kharghar, Navi Mumbai 410210
Raigarh
MAHARASHTRA |
9767614009
renukamoharkar8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | jalaukAvacaraNam, जलौकावचरणम् | (Procedure Reference: Sushrut samhita , Procedure details: Jalaukavcharan with wound dressing & Concomitant medication.)
| | 2 | Intervention Arm | Procedure | - | jalaukAvacaraNam, जलौकावचरणम् | (Procedure Reference: Sushrut Samhita, Procedure details: Patients with lakshana of dushta vrana and fulfilling the inclusion criteria are given
jalaukavcharan therapy
Along with that dressing as per standard dressing protocol ie cleaning of wound and dressing of
wound using appropriate dressing material, securing the dressing, repeating the same daily
and concomitent treatment.
i.e concomitant medication along with JALAUKAVCHARAN and dressing.
Clinical Assessment done on :- 1 st Day, 7th day, 14th day
Follow-up done on : 7th day, 14th day, and 21th day)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clasical signs and symptoms of Dushta vrana |
|
| ExclusionCriteria |
| Details |
Immunocompromised patients with uncontrolled DM, HIV etc
Patients with bleeding disorders
Specific wounds with disorders such as Syphilitic ulcers, Leprosy, Tubercular ulcers. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe rapid wound healing of Dushta Vrana using Jalaukavcharan in pain, wound size and granulation. |
12 months
Clinical assessment on 1,7,14th day
Follow up on 7th, 14th & 21st day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To add Jalaukavcharan along with Ayurveda Therapy in management of Dushta Vrana to reduce the healing period. |
12 months
Clinical assessment on 1,7,14th day
Follow up on 7th, 14th & 21st day. |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
05/11/2025 |
| 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 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
|
Title- Assessment of effect of jalaukavcharan in management of Dushta Vrana W.S.R. to Non Healing ulcers - Randomized control trial.
Sample size- Total - 94
Mode of Administration-
Procedure-
Leeches are prepared for Raktamokshan by placing them in Haridra jala. The ulcerated area is cleaned using normal saline to remove discharge and dry gauze is placed
The leeches are placed directly on the wound or non ulcerated part and skin is punctured using sterile needle to induce bleeding.
Once attached wet cotton pad placed over leech.
After detaching haridra churna is put on leech mouth to induce bleeding.
Leech returned to water.
Schedule- Once a week
Duration - 21 days
Follow up- 7th, 14th, 21st day
Study centre- Dr. G.D. Pol foundation YMT Ayurved Medical college and Hospital, Kharghar, Navi Mumbai
PG Scholar- Dr. Renuka Moharkar
Guide- Dr. Dnyaneshwar Chavan Asso. Proffessor and HOD Shalyatantra Department |