| CTRI Number |
CTRI/2026/03/106094 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
07/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Evaluate the Effectiveness of Modified Jatyadi Ghruta Spray in Healing Chronic Wounds. |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF MODIFIED JATYADI GHRUTA - SPRAY IN THE MANAGEMENT OF DUSHTA VRANA |
| 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 ANUSHA PERUR |
| Designation |
PG SCHOLAR |
| Affiliation |
Muniyal institute of ayurveda medical sciences, Manipal |
| Address |
Out patient department of shalya tantra, room no.9, first floor, muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal,udupi
Udupi
KARNATAKA
576104
India |
| Phone |
8147696510 |
| Fax |
|
| Email |
peruranusha63@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR GURURAJA D |
| Designation |
Professor, HOD |
| Affiliation |
Muniyal institute of ayurveda medical sciences, Manipal |
| Address |
Out patient department of shalya tantra, room no.9, first floor, muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal,udupi
Udupi
KARNATAKA
576104
India |
| Phone |
8762822790 |
| Fax |
|
| Email |
gurushalya@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR ANUSHA PERUR |
| Designation |
PG SCHOLAR |
| Affiliation |
Muniyal institute of ayurveda medical sciences, Manipal |
| Address |
Out patient department of shalya tantra, room no.9, first floor, muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal,udupi
Udupi
KARNATAKA
576104
India |
| Phone |
8147696510 |
| Fax |
|
| Email |
peruranusha63@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Muniyal institute of ayurveda medical sciences Manipal |
| Address |
Out patient department of shalya tantra, room no.9, first floor, muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal,udupi, 576104
Karnataka. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Anusha perur |
Muniyal institute of ayurveda medical sciences, Manipal |
Out patient department of shalya tantra, room no.9, first floor, muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal,udupi
Udupi
KARNATAKA |
8147696510
peruranusha63@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Muniyal institute of ayurveda and medical sciences |
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: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jatyadi ghruta spray, Reference: Sushruta samhita sutrasthana, 23, Route: Topical, Dosage Form: Ghrita, Dose: 00(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: Dose of Jatyadi ghruta spray depends on size of chronic wound | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jatyadi ghruta , Reference: Sushruta samhita, sutrasthana, 23 , Route: Topical, Dosage Form: Ghrita, Dose: 00(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: Dose of Jatyadi ghruta depends on size of chronic wound |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with lakshanas of Dustha Vrana (more than 1 month).
2.Patient of either sex in the age group of 18 to 60 years.
3.All types of non specific ulcer.
4.Patients with controlled systematic disease.
5.Patients pre diagnosed diabetes mellitus with HbAlc less than 6 or 6.
|
|
| ExclusionCriteria |
| Details |
1.Patients having complications like malignancy, gangrene, leprosy, TB wound, osteomyelitic ulcer.
2.Pregnant and lactating women will be excluded.
3.Patients with H.I.V, HbsAg, HCV.
4. Patients with uncontrolled systemic diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in wound size, and healing of wound |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain, discharge, and odour from wound |
28 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
13/04/2026 |
| 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="4"
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
|
In India, chronic wounds affect approximately 1.89 per 1,000 individuals, with a slightly higher prevalence in rural areas compared to urban regions. Ayurveda, particularly the classical text Sushruta Samhita, emphasizes the importance of wound management (Vrana) and describes Shasti Upakrama-sixty therapeutic procedures for treating wounds using cleansing (Shodhana) and healing (Ropana) methods.Jatyadi Ghruta, described in Bhaishajya Ratnavali, is a traditional ghee-based polyherbal formulation containing eleven herbal ingredients and is widely used for treating Dushta Vrana (chronic or infected wounds). Its components possess antimicrobial, anti-inflammatory, and antiseptic properties, which support wound healing. To improve practicality and patient compliance, Jatyadi Ghruta can be transformed into a spray formulation. This modification makes the application easier, more hygienic, and suitable for large or sensitive wounds by avoiding direct contact and reducing contamination risk. The spray also provides a cooling and soothing effect, enhancing comfort for inflamed or ulcerated skin. Thus, the spray formulation combines traditional Ayurvedic knowledge with modern pharmaceutical approaches to improve wound care effectiveness and usability. |