| CTRI Number |
CTRI/2025/04/084189 [Registered on: 04/04/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Durva taila in management of Sadyovrana |
|
Scientific Title of Study
|
An open randomized controlled clinical trial to evaluate efficacy of Durva taila in management of Sadyovrana |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAURABH SHESHRAO AWGHADRAO |
| Designation |
PG scholar |
| Affiliation |
Hon. Shree Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
| Address |
OPD No 13 Shalya Tantra OPD, ground floor, Dhanvantri ayurveda hospital Ashta, Tal Walwa, Dist Sangli
OPD No 13 Shalya Tantra OPD, ground floor, Dhanvantri ayurveda hospital Ashta, Tal Walwa, Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
7060760800 |
| Fax |
|
| Email |
sawghadrao@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIJAY DANGE |
| Designation |
ASSO. PROFESESSOR |
| Affiliation |
Hon. Shree Annasaheb Dange Ayurved Medical College Post Graduate And Research Center, Ashta |
| Address |
5th floor department of shalyatantra Hon Shree Annasaheb Dange Ayurved Medical college post Graduate And Research Center Ashta Tal Walwa Dist Sangli
5th floor department of shalyatantra Hon Shree Annasaheb Dange Ayurved Medical college post Graduate And Research Center Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
8600600181 |
| Fax |
|
| Email |
drvijaydange@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VIJAY DANGE |
| Designation |
ASSO. PROFESESSOR |
| Affiliation |
Hon. Shree Annasaheb Dange Ayurved Medical College, Ashta |
| Address |
5th floor department of shalyatantra Hon Shree Annasaheb Dange Ayurved Medical college post Graduate And Research Center Ashta Tal Walwa Dist Sangli
5th floor department of shalyatantra Hon Shree Annasaheb Dange Ayurved Medical college post Graduate And Research Center Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
8600600181 |
| Fax |
|
| Email |
drvijaydange@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta, Tal Walwa, Dist Sangli, Maharashtra, 416301 |
|
|
Primary Sponsor
|
| Name |
DR SAURABH AWGHADRAO |
| Address |
OPD No 13 Shalyatantra OPD , Tal Walwa, Dist Sangli, Maharashtra, 416301 |
| Type of Sponsor |
Other [Selfi] |
|
|
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 SAURABH AWGHADRAO |
Hon Shri Annasaheb Dange Ayurved Medical COllege Post Graduate And Research Center Ashta |
Opd no 13,shalyatantra
opd, ground floor,
dhanvantari ayirved
hospital, Ashta Sangli
416301
Sangli
MAHARASHTRA
Sangli
MAHARASHTRA |
7060760800
sawghadrao@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Of Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Research Center Ashta Sangli |
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: SADYOVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | tailam, तैलम् | (Procedure Reference: Shastri Ambikadatta K., Sushruta Samhita, Ayurved Tatwa Sandipika hindi commentary, Vol.1., Chaukhamba Prakashan, Varanasi, reprint 2022, Chiktsasthan, Chapter-1, page no.5, Procedure details: Application of durva tail on sadyovrana for 7 days)
(1) Medicine Name: Durva taila, Reference: Padmashree prof K.C. Chunekar, Bhavaprakash Nighantu. Edited by Late Dr. G. S. Pandey, Chaukhamba Prakashan, Varanasi, Reprint 2022, page no 371, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Povidone iodine solution | rout is topical, dosage 5ml, frequency od, duration 7days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age – 18 to 60 years
2. Patent of either sex will be taken
3. Subject with Lakshanas of Sadyovrana
4. Wound size up to 5 square centimeters
|
|
| ExclusionCriteria |
| Details |
1. Patient with infected wound.
2. Patient with known history of DM, HIV, HBsAG, Tuberculosis or any other systemic.
3. Malignant ulcer .
4. Patient with burn.
5. Ulcer due to varicose veins
6. Ulcer due to radiation therapy
7. Vrana on Head, neck region.
8. Features showing gangrene.
9. Any complication will be excluded
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Durva taila is effective in the management of sadyovarna within 7 days |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| povidone iodine solution in the management of sadyovarna |
7 days |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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="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
|
In 2nd chapter of Sushrut chikitsa sthana - Sadyovraneeya Adhyaya explained the Sadyovrana in detail which comes under Aagantuja Vrana. Aagantuja vrana are a fresh wound caused by purusha, pashu, pakshi, vyaala, prapatana, peedana, prahar, tikshna aoushadha, agni, kshara, visha, kapaala, shringa and injury by such other weapons. Acharya Bhavprakash mentioned a Durva which is helpful in healing of wound. so keeping all above in mind durva taila is choosen for management of sadyovrana. Durva taila will be applied to patient for 7 days alternate day once in a day for 36 patient, Povidone iodine solution will be applied to 36 patient for 7 days for alternate day, and result will be noted |