| CTRI Number |
CTRI/2026/03/105536 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to compare the effect of Gandiradi Taila and Jatyadi Taila in the treatment of Dushta vrana in diabetic foot ulcer patients |
|
Scientific Title of Study
|
Randomised Comparative Study of Gandiradi Taila and Jatyadi Taila in The Management of Dushta Vrana (Diabetic foot 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 |
Vd Vatsal Sunil Jawanjal |
| Designation |
PG Scholar |
| Affiliation |
Ashvin Rural Ayurved College And Hospital Manchi Hill Sangamner |
| Address |
Opd No 12 shalyatantra Department Ashvin Rural Ayurved college And Hospital Preeti Sudhaji Maharaj Nagar At Manchi Hill Post Ashvi Bk Tal Sangamner Dist Ahmadnagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
9156330085 |
| Fax |
|
| Email |
jawanjalvatsal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Vishal Tamhane |
| Designation |
Reader |
| Affiliation |
Ashvin Rural Ayurved College And Hospital Manchi Hill Sangamner |
| Address |
Opd No 12 shalyatantra Department Ashvin Rural Ayurved college And Hospital Preeti Sudhaji Maharaj Nagar At Manchi Hill Post Ashvi Bk Tal Sangamner Dist Ahmadnagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
9764139607 |
| Fax |
|
| Email |
vvtamhane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Vatsal Sunil Jawanjal |
| Designation |
PG Scholar |
| Affiliation |
Ashvin Rural Ayurved College And Hospital Manchi Hill Sangamner |
| Address |
Opd No 12 shalyatantra Department Ashvin Rural Ayurved college And Hospital Preeti Sudhaji Maharaj Nagar At Manchi Hill Post Ashvi Bk Tal Sangamner Dist Ahmadnagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
9156330085 |
| Fax |
|
| Email |
jawanjalvatsal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vd Vatsal Sunil Jawanjal |
| Address |
Opd No 12 Shalyatantra Department Ashvin Rural Ayurved college And Hospital Preeti Sudhaji Maharaj Nagar Manchi Hill Tal Sangamner Dist Ahmadnagar 413714 |
| 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 Vatsal Jawanjal |
Ashvin Rural Ayurved college And Hospital Manchi Hill Post Ashvi Bk Tal Sangamner Dist Ahmadnagar |
Opd No 12 Shalyatantra Department Ashvin Rural Ayurved college And Hospital Manchi Hill Post Ashvi Bk Tal Sangamner Dist Ahmadnagar
Ahmadnagar
MAHARASHTRA |
9156330085
vatsaljawanjal1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Ashvin Rural Ayurved college And Hospital Manchi Hill Sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E116||Type 2 diabetes mellitus with other specified complications. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gandiradi Taila , Reference: Chakradatta 50/160, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jatyadi Taila , Reference: Sharangdhar samhita madhyam khanda 9/168-171, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Individuals presenting with a diagnosis of Dushta Vrana (Diabetic foot ulcer) with signs and
symptoms of Dushta Vrana as per Sushruta Samhita.
1. Patients of age group between 30-70 years.
2. Patients will be included regardless of their socioeconomic status, financial
background, or gender.
3. Patient with Dushta Vrana associated with controlled diabetes mellitus.
4. Patient with Dushta Vrana with a maximum history of 8 months.
5. Dushta Vrana of size 3-8 cm in length and width. |
|
| ExclusionCriteria |
| Details |
1. Individuals with a diagnosis of Tuberculosis, Sepsis, Neurological conditions, or
vascular diseases.
2. Patients presenting with trophic ulcers or ulcers resulting from animal bites.
3. Those with pre-existing bleeding disorders.
4. Individuals younger than 30 years or older than 70 years of age.
5. Patients with a confirmed diagnosis of Anaemia.
6. The presence of cancerous (carcinomatous) lesions.
7. Wounds resulting from burns (Dagdha Vrana).
8. Patients with sexually transmitted diseases (STDs).
9. Pregnant women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of Gandiradi Taila and Jatyadi Taila in the Management of Dushta Vrana (Diabetic foot) |
28 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in wound size
Reduction in Discharge/Slough
Pain reduction |
28 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/03/2026 |
| 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="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
|
• Diabetic foot ulcer is one of the toughest wounds to treat, as healing is often slow and complications are common. • Jatyadi Taila has been studied in detail, and its benefits in wound healing are well known. • Gandiradi Taila is described in ayurvedic texts but has hardly been studied, with only one clinical trial reported. • A study is needed to evaluate this lesser explored formulation and compare it with the well-established Jatyadi Taila. • By comparing Gandiradi Taila with Jatyadi Taila, the study aims to find out which one works better for healing diabetic foot ulcers. • This study will also add scientific evidence to Ayurveda and bridge the current research gap |