| CTRI Number |
CTRI/2025/07/090103 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare healing effects of yava kalka churna with ghrita and Povidone Iodine ointment on shuddha vrana |
|
Scientific Title of Study
|
Randomised Controlled Clinical Study of Application of Yava kalka churna with ghrita in comparison with application of Povidone Iodine ointment in the management of shuddha 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 Gajanan Laxman Surkar |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya , Rasta Peth , Pune |
| Address |
Department of Shalya Tantra, Tilak Ayurved Mahavidyalaya, Rasta Peth , Pune - 11
Pune
MAHARASHTRA
411011
India |
| Phone |
7020994906 |
| Fax |
|
| Email |
gajanansurkar147@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipak Poman |
| Designation |
Asso. Professor |
| Affiliation |
Tilak Ayurved Mahavidyalaya , Rasta Peth , Pune |
| Address |
Department of Shalya Tantra, Tilak Ayurved Mahavidyalaya, Rasta Peth , Pune - 11
Pune
MAHARASHTRA
411011
India |
| Phone |
8308612087 |
| Fax |
|
| Email |
dipakpoman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gajanan Laxman Surkar |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya , Rasta Peth , Pune |
| Address |
Department of Shalya Tantra, Tilak Ayurved Mahavidyalaya, Rasta Peth , Pune - 11
Pune
MAHARASHTRA
411011
India |
| Phone |
7020994906 |
| Fax |
|
| Email |
gajanansurkar147@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurvedic Hospital, Rasta Peth, Pune 411011
Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya, Rasta Peth, Pune 411011 |
| 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 Gajanan Laxman Surkar |
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Cheritable Ayurved Hospital |
OPD no 7 , Department of Shalya Tantra , Ground floor, Rasta Peth, Pune
Pune
MAHARASHTRA |
7020994906
gajanansurkar147@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee TAMV, Pune |
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: VRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: yava kalka with ghrita, Reference: siddhasara samhita adhyaya 25 shlok no.9, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Povidone Iodine ointment | Application of Povidone Iodine ointment over wound once a day for 7 days |
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1 Participants having Shuddha Vrana irrespective of sex age occupation
2 Fresh incised wounds,superficial wounds lacerated wounds within 24 hours will be selected 3 Uninfected wounds in process of healing will be selected
4 Non-infected Diabetic wound with healthy granulation BSLR less than 200mg per dl |
|
| ExclusionCriteria |
| Details |
1 Known case of Venous Tubercular Ischemic 1Tropical Neurogenic malignant ulcers
2 Infected wounds
3 Diabetic Wounds having discharge or slough BSL R more than 200 mg perdl
4 Participant suffering from HIV HbsAG
5 Wound having dimension more than 6cm |
|
|
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 |
To compare the wound healing property of yava kalka churna ghrita with povidone-iodine
ointment. |
1st follow up on 3rd day and then on 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the adverse drug effect of Yava kalka churna with ghrita (if any). |
1st follow up on 3rd day and then on 7th day |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
15/07/2025 |
| 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
|
Randomised Controlled Clinical Study of Application of Yava Kalka Churna with Ghrita in Comparison with Application of Povidone-Iodine Ointment in the Management of Shuddha Vrana. Objective:To evaluate the efficacy of a traditional Ayurvedic formulation (Yava Kalka Churna with Ghrita) versus a modern antiseptic (Povidone-Iodine ointment) in treating Shuddha Vrana (clean wounds). Methodology: Study Design: Randomized, open-label, controlled clinical trial. Sample Size: 88 participants, divided into two groups (44 each). Group A (Trial): Treated with Yava Kalka Churna + Ghrita. Group B (Control): Treated with Povidone-Iodine ointment. Duration: 7 days, with follow-ups on Day 3 and Day 7. Parameters: Wound size, color, pain, healing duration, burning sensation. Evaluation: Subjective and objective clinical parameters were used, supported by statistical tests (t-test, chi-square, etc.). Hypotheses:Yava Kalka Churna with Ghrita is more/equally effective or not effective compared to Povidone-Iodine. Ethics & Approvals:Approved by the Institutional Ethical Committee. Includes informed consent forms and protocol documentation. Outcome:The study aims to provide evidence-based validation of Ayurvedic wound treatments and promote integration with modern medical practices. |