| CTRI Number |
CTRI/2024/12/078811 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2025 |
| 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 clinical trial on management of clean wound with the application of Nimbatwak ointment. |
|
Scientific Title of Study
|
Study the efficacy of Nimba Twak ointment in the patients of Shuddha Vrana (clean wound) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaishnavi Hatwar |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital Pune |
| Address |
Bharati Vidyapeeth (Deemed to be university) College of Ayurved Department of Shalyatantra OPD No. 03 Dhankawadi Katraj
Pune
MAHARASHTRA
411043
India |
| Phone |
9175634508 |
| Fax |
|
| Email |
vaishnavi.hatwar-ayurved@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umesh A Vaidya |
| Designation |
Professor and HOD |
| Affiliation |
Bharati Vidyapeeth College of Ayurved and Hospital, Pune |
| Address |
Bharati Vidyapeeth (Deemed to be university) College of Ayurved Department of Shalyatantra OPD No. 03, Dhankawadi Katraj
Pune
MAHARASHTRA
411043
India |
| Phone |
9822376169 |
| Fax |
|
| Email |
umesh.vaidya@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Umesh A Vaidya |
| Designation |
Professor and HOD |
| Affiliation |
Bharati Vidyapeeth College of Ayurved and Hospital, Pune |
| Address |
Bharati Vidyapeeth (Deemed to be university) College of Ayurved Department of Shalyatantra OPD No. 03, Dhankawadi Katraj
Pune
MAHARASHTRA
411043
India |
| Phone |
9822376169 |
| Fax |
|
| Email |
umesh.vaidya@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Vaishnavi Hatwar |
| Address |
Bharati Vidyapeeth (Deemed to be University) College of Ayuved and Hospital Department of Shalyatantra |
| 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 Vaishnavi Hatwar |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital Department of Shalya Tantra OPD No 3 Dhankawadi Katraj Pune
Pune
MAHARASHTRA |
9175634508
vaishnavi.hatwar-ayurved@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T758||Other specified effects of external causes. Ayurveda Condition: VRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nimba twak ointment, Reference: Bhavprakash Nighantu - Guduchyadi varga, 94-96, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Povidine iodine | 5% w/w povidine iodine with water soluble ointment base will be applied once a day for 7 to 21 days till healing of wound |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex between 18 to 60 years of ageand having the sign and symptoms of Shuddha Vrana will be included in the study. |
|
| ExclusionCriteria |
| Details |
Patients suffering from Dushta Vrana (npn-healing wounds), wounds associated with systemic diseases like malignant wounds, arterial, varicose ulcer, pressure ulcer, HbsAg, HIV I and II positive will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in pain, size of wound and discharge |
baseline or 7th, 14th and 21st days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| cleaning of wound bed with reduction in slough |
baseline or 7th, 14th & 21st 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)
|
12/01/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study will be conducted after obtaining permission from IEC and will be registered in CTRI. This study is randomized, parallel group, active controlled trial comparing the safety and efficacy of Nimbatwak ointment for topical application on clean wounds. Patient will be selected as per Inclusion / Exclusion criteria. Patient will be observed and if patient is not following the treatment protocol or not willing to continue treatment can be considered as a drop out.Ayurveda is acknowledged as a complementary and alternative medical system that needs to be modernized and incorporate scientific methods for drug production, administration, and care of patients. Research into the phenomena of Vranaropana can make a substantial contribution to the problem of clean wound healing. Promising results have been observed in previous studies. |