| CTRI Number |
CTRI/2025/03/082925 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Udumbar ghrita on non healing ulcer. |
|
Scientific Title of Study
|
An open randomized comparative clinical study to assess the shodhan and ropana effect of Udumbar Ghrita in management of Dushta Vrana w.s.r to Non Healing 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 |
Dr Aditi Patil |
| Designation |
PG Scholar |
| Affiliation |
Dr.G.D.Pol Foundations YMT Ayurvedic Medical College and Hospital Kharghar |
| Address |
3rd floor shalyatantra department Dr G D pol foundation YMT ayurvedic medical college and hospital PG Institute sector 4 kharghar Navi mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8007918393 |
| Fax |
|
| Email |
aditipatil498@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Yadav |
| Designation |
Professor |
| Affiliation |
Dr.G.D.Pol Foundations YMT Ayurvedic Medical College and Hospital Kharghar |
| Address |
3rd floor shalyatantra department Dr G D pol foundation YMT ayurvedic medical college and hospital PG Institute sector 4 kharghar Navi mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9322456999 |
| Fax |
|
| Email |
drsanjeevyadav22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditi Patil |
| Designation |
PG Scholar |
| Affiliation |
Dr.G.D.Pol Foundations YMT Ayurvedic Medical College and Hospital Kharghar |
| Address |
3rd floor shalyatantra department Dr G D pol foundation YMT ayurvedic medical college and hospital PG Institute sector 4 kharghar Navi mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8007918393 |
| Fax |
|
| Email |
aditipatil498@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr G D pol
foundation YMT
ayurvedic medical
college and hospital PG
Institute sector 4
kharghar Navi Mumbai
410210
Raigarh
MAHARASHTRA |
|
|
Primary Sponsor
|
| Name |
Dr Aditi Patil |
| Address |
Dr G D pol
foundation YMT
ayurvedic medical
college and hospital PG
Institute sector 4
kharghar Navi Mumbai
410210
Raigarh
MAHARASHTRA |
| 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 |
| Dr Aditi |
Dr G D pol foundation YMT ayurvedic medical college and hospital PG Institute |
Ward no - 405,505,
4th floor and
5th floor Dr G D pol
foundation YMT
ayurvedic medical
college and hospital PG
Institute sector 4
kharghar Navi Mumbai
410210
Raigarh
MAHARASHTRA
Raigarh
MAHARASHTRA |
8007918393
aditipatil498@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee of YMT Ayurvedic Medical College & Hospital. P.G.Institute, Kharghar, Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L984||Non-pressure chronic ulcer of skin, not elsewhere classified. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bandhanakarma, बन्धनकर्म | (Procedure Reference: Shashtri, Kaviraj Ambikadatta. Sushrut Samhita. varanasi : Choukhamba Sanskrit Prakashan, 2021. VOL 1,Chikitsasthan,Verse 8 p.5., Procedure details: Patient will receive local application of Udumbar Ghrita, once a day, for 21 days )
(1) Medicine Name: udumbar ghrita, Reference: Tripathi B, Sarngadhara-Samhita of pandit Sarngadharacarya, reprint 2006, Varanasi UP, Chaukhbha surabharati prakashan, page no.218, Route: Topical, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Duration: 21 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Povidone-iodine | Route: topical, frequency: OD, Duration: 21 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18 - 60 yrs of age.
2.All non healing ulcers with size of wound not more than 5-
7cm and depth not more than 1.5cm
3.Patients selected irrespective of age, sex, education and
habit. |
|
| ExclusionCriteria |
| Details |
1.Cold abscess , gangrene, malignant ulcer , tuberculous
ulcer, lepromatous ulcer.
2.Hb less than 10 g/dl.
3.BSL(R) more than 200 mg/dl.
4.Immunocompromised patients , any bleeding disorder,
patient in septicemia. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
A.Subjective criteria
1.Shoola(Pain)
B.Objective criteria
1.size of wound
2.Depth of wound
3.colour (of surrounding skin)
4.odour
5.Strava(discharge)
6.Floor and granulation tissue |
1st 7th 14th 21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Udumbar ghrita is effective in shodhana and ropana of dushta vrana w.s.r.t non healing ulcer. The shodhana and ropana effect of udumbar ghrita on non healing ulcer w.r.t size, depth, discharge and granulation of wound. |
21 days |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
01/07/2025 |
| 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="0"
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
|
AN OPEN RANDOMIZED COMPARATIVE CLINICAL STUDY TO ASSESS THE SHODHAN AND ROPANA EFFECT OF UDUMBAR GHRITA IN MANAGEMENT OF DUSHTA VRANA W.S.R TO NON HEALING ULCER.
Sample size - 102
Mode of administration- local application
A.Subjective criteria 1.Shoola(Pain)
B.Objective criteria 1.size of wound 2.Depth of wound 3.colour (of surrounding skin) 4.odour 5.Strava(discharge) 6.Floor and granulation tissue |