| CTRI Number |
CTRI/2026/01/100123 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of eusol and karpuradi ghrita in dushta vrana |
|
Scientific Title of Study
|
Randomised controlled clinical study to evaluate the efficacy of karpuradi ghrita and eusol 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 Omkar Sarjerao Salunkhe |
| Designation |
MS Scholar Shalyatantra (Ayurveda) |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Malwadi Hadapsar Pune Maharashtra 411028 |
| Address |
OPD NO 3 Department of Shalyatantra Sane Guruji Arogya Kendra Malwadi Road Hadapsar Pune Maharashtra 411028
Pune
Maharashtra
411028
India
OPD NO 3 Department of Shalyatantra Sane Guruji Arogya Kendra Malwadi Road Hadapsar Pune Maharashtra 411028
Pune
Maharashtra
411028
India
Pune
MAHARASHTRA
411028
India |
| Phone |
8668716088 |
| Fax |
|
| Email |
salunkheomkar011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANDIP M MALI |
| Designation |
MS PhD Associate professor |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Malwadi Hadapsar Pune Maharashtra 411028 |
| Address |
OPD NO 3 Department of Shalyatantra Sane Guruji Arogya Kendra Malwadi Road Hadapsar Pune Maharashtra 411028
Pune
Maharashtra
411028
India
OPD NO 3 Department of Shalyatantra Sane Guruji Arogya Kendra Malwadi Road Hadapsar Pune Maharashtra 411028
Pune
Maharashtra
411028
India
Pune
MAHARASHTRA
411028
India |
| Phone |
9284993423 |
| Fax |
|
| Email |
Sandymonias@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Omkar Sarjerao Salunkhe |
| Designation |
MS Scholar Shalyatantra (Ayurveda) |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Malwadi Hadapsar Pune Maharashtra 411028 |
| Address |
OPD NO 3 Department of Shalyatantra Sane Guruji Arogya Kendra Malwadi Road Hadapsar Pune Maharashtra 411028
Pune
Maharashtra
411028
India
OPD NO 3 Department of Shalyatantra Sane Guruji Arogya Kendra Malwadi Road Hadapsar Pune Maharashtra 411028
Pune
Maharashtra
411028
India
Pune
MAHARASHTRA
411028
India |
| Phone |
8668716088 |
| Fax |
|
| Email |
salunkheomkar011@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sane Guruji Arogya Kendra Malwadi hadapsar pune india 411028 |
|
|
Primary Sponsor
|
| Name |
Sane Gurujii Arogya Kendra Malwadi Hadapsar Pune india |
| Address |
Department of Shalyatantra Sane Gurujii Arogya Kendra Malwadi Hadapsar Pune India 411028 |
| 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 Omkar Sarjerao Salunkhe |
SANE GURUJI AROGYA KENDRA |
Shalyatantra department Ward no 2-IPD , OPD NO 3 SANE GURUJI AROGYA KENDRA MALWADI HADAPSAR PUNE INDIA 411028
Pune
MAHARASHTRA |
8668716088
Salunkheomkar011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL CIMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Eusol | Eusol is a germicidal means covers both category of drugs i.e. sloughing, disinfectant and antiseptic. The agents used for inanimate objects are called disinfectant and on living surfaces are called antiseptic. No staining with agreeable odour and colour. Active against all pathogens – bacteria, fungi and protozoa. Rapid in action and exert sustained protection till 24 hours. It is strong oxidizing agent which oxidized bacterial protoplasm | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Karpuradi ghrita, Reference: SAHASTRAYOGA VATI PRAKARANA KALPA 13 PAGE NO 313 , Route: Topical, Dosage Form: Ghrita, Dose: 02(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -karpuradi ghrita is very effective in the management of dushta vrana |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having infected wound. Age 18 to 60 yrs., Irrespective of Gender. Wound size 1 × 1 cm to 8 × 8cm. Infected wound due to trauma & accident with foul smell and pus discharge. Post- operative all infected wound. Diabetic Mellitus. HTN |
|
| ExclusionCriteria |
| Details |
Gangrenous wound. Neo-plastic ulcer. Burn, Arterial ulcer, Gout, Renal failure. Liver failure. Bed Sores. Varicose ulcer. HIV & Immuno-compromised patients. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Study efficacy of karpuradi ghrita in the management of dushta vrana |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the efficacy of karpuradi ghrita and eusol in the management of dushta vrana |
15 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)
|
15/01/2026 |
| 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 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 day-to-day life wound is very common problem. dushta vrana is more faced condition. once the vrana becomes dushta it worsens the condition of the patient which delays healing process of vrana , different complications and may become fatal. wound healing is natural process wound healing depends on many factors like slough, infection, and foreign body which affects the normal process of healing. in present day wound is said to be healed when epithelization is complete. infected wound takes more time to heal. wound healing is a mechanism where by the body attempts to restore the integrity of injured part. hence good wound healing with minimal scar is the prime moto. Karpuradi ghrita is vrana shodhak due to its rasa, guna, virya, viapaka use of such plant material in the management of dushta vrana when there is unavaliability of solutions will help to solve this issues |