| CTRI Number |
CTRI/2023/12/060485 [Registered on: 04/12/2023] Trial Registered Prospectively |
| Last Modified On: |
01/12/2023 |
| 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
|
Study the effect of ayurvedic ointment on wound healing ativity |
|
Scientific Title of Study
|
Randomized Controlled Clinical Study to Evaluate the Efficacy of Palash Panchang Extract Ointment in Dushta Vrana with special reference to Post Fistulectomy Wounds |
| 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 Kshitij Manohar Bhamre |
| Designation |
PG SCHOLAR |
| Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyalaya Ganeshwadi, Panchavati Nashik |
| Address |
OPD no 6 Shalyatantra OPD
Nashik Maharashtra
Nashik
MAHARASHTRA
422003
India |
| Phone |
9145548205 |
| Fax |
|
| Email |
Chinnudada2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Dixit |
| Designation |
Associate Proffesor Shalyatantra Department |
| Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyalaya Ganeshwadi, Panchavati Nashik |
| Address |
Ayurved Seva Sangh Ayurved Mahavidyalaya Ganeshwadi, Panchavati Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9011045371 |
| Fax |
|
| Email |
pankajdixitofficial@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Dixit |
| Designation |
Associate Proffesor Shalyatantra Department |
| Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyalaya Ganeshwadi, Panchavati Nashik |
| Address |
Ayurved Seva Sangh Ayurved Mahavidyalaya Ganeshwadi, Panchavati Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9011045371 |
| Fax |
|
| Email |
pankajdixitofficial@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik Ganeshwadi Panchavati Nashik |
|
|
Primary Sponsor
|
| Name |
Dr.Kshitij Manoharr Bhamre |
| Address |
Ayurved Seva Sangh Ayurved Mahavidyalay Nashik |
| 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 Kshitij Manohar Bhamre |
Arogyashala Rugnalaya |
OPD NO. 06, Shalyatantra opd
Nashik
MAHARASHTRA |
9145548205
Chinnudada2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committe ayurveda mahavidyalaya nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L762||Postprocedural hemorrhage of skinand subcutaneous tissue following a procedure. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Palash Panchang extract ointment, Reference: Bhavprakash purva khanda, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -Local application of palash panchang extract ointment over post fistulectomy wounds for 21 days once in a day for clinical study | | 2 | Comparator Arm (Non Ayurveda) | | - | Betadine ointment | Local application of betadine ointment over post fistulectomy wounds for 21 days once in a day for clinical study |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients who will give consent for study
2)Both Male and female
3)Patient with post fistulectomy wound
4)Patient having foul smell, pus discharge ,pain, burning sensation and edema were selected for study
5)Wound upto 20cm2
6)Bates Janesen ulcer assessment score above 30
|
|
| ExclusionCriteria |
| Details |
1) Patients suffering from systemic disease like Tuberculosis , CKD, Severe Anemia , Malnutrition were excluded from the study
2) Patient having immunosuppressive disorder
3) Patient on immunosuppressive drugs
4) Wound Size greater than 20cm2
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in signs and symptoms with early healing of dushta vrana |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in pain,foul smell,pus discharge To promote early healing |
21 days |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
12/12/2023 |
| 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="0"
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
|
Ayurveda the indigenous system of medicine is an integral part of Indian culture. The ancient acharyas from centuries had used many formulations for prevention and treatment of various entities.In a medical practice, healing of wound (vrana) in a short period of time is very important factor.In modern lifestyle we come across many such patients with varieties of wound .Even though healing of wound is a natural process of body, the vrana should be protected from doshadushti and from various infections which may hamper the natural rate of healing of wound. In modern era fistula is amongst most common disorder and fistulectomy is a surgical procedure which often occurs in modern surgical practices. Not only by excising fistulous fibrous tract you can conquer this enitity but also by its post surgical wound management you can resolve it by stopping its chances of recurrence.. Acharya Sushruta explained vrana ,bhagandara and shastrakrut vrana in detail in his classical book Sushruta Samhita.Palash (Butea Monosperma) is a one which have key role in management of vrana. According to bhavprakash it is â€vranagulmajit†means one posseses quality to cure vrana and gulma.Also dhanvantari nighantu tells about its quality to cure vrana Therefore a randomized controlled clinical study to evaluate efficacy of palash panchang extract ointment in dushta vrana is selected for clinical study. In this study total 66 patients will be randomly selected showing signs and symptoms of post fistulectomy wounds are randomized into 2 groups. The trial group will be treated with palash panchang extract ointment while control group will be treated with betadine ointment. In clinical study patients will be examined according to subjective criteria which includes BATES-JENSEN ulcer assessment tool ,and objective criteria includes 1.pain scale 2.itching scale for wound for 21 days.The observations will be drawn after completion of clinical study and conclusion will be drawn accordingly. The study will be published after completion of trial. |