| CTRI Number |
CTRI/2025/06/088791 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
12/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative clinical study on the effectiveness of Bala Taila pichu (oil soaked bandage) and Povidone Ointment in the management of healthy wound. |
|
Scientific Title of Study
|
Randomized controlled clinical study to evaluate the efficacy of Bala Taila Pichu and Povidone 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 |
DrShivanjali Yashvantrao Karande |
| Designation |
MS Scholar Shalyatantra |
| Affiliation |
Tilak Ayurveda Mahavidyalaya, 583/2 Rasta Peth, pune 411011Pune |
| Address |
Department of Shalyatantra, 2nd Floor, Tilak Ayurveda Mahavidyalaya, 583/2, Rasta peth, Pune, Maharashtra
Pune
MAHARASHTRA
411011
India |
| Phone |
9011362614 |
| Fax |
|
| Email |
shivanjalikarande15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitin D Nalawade |
| Designation |
Associate Professor Department of Shalakyatantra |
| Affiliation |
Tilak Ayurveda Mahavidyalaya, 583/2, Rasta Peth, Pune |
| Address |
Department of Shalyatantra, 2nd Floor, Tilak Ayurveda Mahavidyalaya, 583/2, Rasta peth, Pune, Maharashtra
Pune
MAHARASHTRA
411011
India |
| Phone |
9822522905 |
| Fax |
|
| Email |
nalawadenitin54@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitin D Nalawade |
| Designation |
Associate Professor Department of Shalakyatantra |
| Affiliation |
Tilak Ayurveda Mahavidyalaya, 583/2, Rasta Peth, Pune |
| Address |
Department of Shalyatantra, 2nd Floor, Tilak Ayurveda Mahavidyalaya, 583/2, Rasta peth, Pune, Maharashtra
MAHARASHTRA
411011
India |
| Phone |
9822522905 |
| Fax |
|
| Email |
nalawadenitin54@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Seth Tarachand Ramnath Charitable Ayurvedic Hospital, 583/2, Rasta Peth, Pune 411011 |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurveda Mahavidyalaya |
| Address |
Tilak Ayurveda Mahavidyalaya Rasta Peth Pune - 411011, Maharashtra, india |
| Type of Sponsor |
Private medical college |
|
|
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 Shivanjali Yashvantrao Karande |
Seth Tarachand Ramnath Charitable Ayurvedic Hospital Pune |
Department of Shalyatantra Opd 07, Ground floor, Rasta Peth, Pune 411011 Pune, Maharashtra
Pune
MAHARASHTRA |
9011362614
shivanjalikarande15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Tilak Ayurveda MahavidyalayaPune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L989||Disorder of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: VRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | picu, पिचु | (Procedure Reference: Chikitsarnav Sharirvrana Chikitsa Adhyaya Shloka No.3, Procedure details: Bala Taila Pichu will be placed over shuddha vrana once a day for 7 days.)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Povidone Ointment | Povidone ointment will be locally applied over healthy wound once a day for 7 days. |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants having Shuddha Vrana Irrespective of Sex, age, occupation.
2.Fresh Incised wounds, lacerated wounds, superficial wounds within 24 hours will be selected.
3.Surgical wound e.g. post operative circumcision wound.
4.Uninfected wounds in process of healing will be selected.
5.Non infected diabetic wound with healthy granulation (BSL-R less than 200mg/dl) |
|
| ExclusionCriteria |
| Details |
1.Known case of venous, tubercular, ischemic, tropical, neurogenic, malignant ulcers.
2.Infected wounds
3.Diabetic wounds having discharge or slough (BSL-R more than 200mg/DL)
4.Participant known case of HIV, HbsAG. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in Pain and swelling at wound site |
3 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complete relief in Pain & swelling & healthy healing |
7 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/ 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 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
|
The study will be intervened by the treatment of Bala Taila Pichu and Povidone ointment to group A and group B respectively. The efficacy of the therapy will be assessed on the basis of subjective and objective criteria for statistical analysis. Scoring will be designed according to the severity of symptoms. The subjective and objective gradation of symptoms will be done as follows and the intensity of each symptom will be calculated before treatment, after treatment and after follow up. The effect of treatment result will be assessed in regards to clinical signs and symptoms on the basis of grading and scoring system. The signs and symptoms will be assessed by adopting the suitable scoring method. |