| CTRI Number |
CTRI/2024/06/069115 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An Ayurvedic drug trial on chronic wounds |
|
Scientific Title of Study
|
An exploratory study to evaluate the wound healing activity of Priyangudhatakyadi Taila in Dushta Vrana with special reference to chronic 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 Nasrin Habeeb |
| Designation |
Junior Resident |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Shalyatantra
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
6282990435 |
| Fax |
|
| Email |
nasrinhabeeb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Rahul Sherkhane |
| Designation |
Professor and Head of Department |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Shalyatantra
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8233829723 |
| Fax |
|
| Email |
rahulsherkhane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nasrin Habeeb |
| Designation |
Junior Resident |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Shalyatantra
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
6282990435 |
| Fax |
|
| Email |
nasrinhabeeb@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Sunderlal Hospital
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi |
|
|
Primary Sponsor
|
| Name |
Department of Shalyatantra |
| Address |
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi
221005
India |
| 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 Nasrin Habeeb |
Sir Sunderlal Hospital Banaras Hindu University |
OPD No.12,14,16A, NRC
Indian Medicine Wing
Department of Shalyatantra
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi
UTTAR PRADESH |
6282990435
nasrinhabeeb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, IMS, BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L984||Non-pressure chronic ulcer of skin, not elsewhere classified. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Priyangudhatakyadi Taila, Reference: Cakradatta Vidradhi adhikara, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 28 Days, Reference: No, Route: -, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Povidone iodine | |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Mild and moderately infected wounds of all types
2. Patients with controlled diabetes
|
|
| ExclusionCriteria |
| Details |
1. Malignant ulcers
2. Tuberculous ulcers
3. Syphilitic ulcers
4. Leprotic ulcer and other specific ulcers
5. Actinomycosis
6. Wounds with associated Osteomyelitis
7. Anaemia
8. Jaundice
9. Malnutrition
10. Wounds in HIV patients and immuno-compromised patients |
|
|
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 |
1. Assessment of the wound healing activity of Priyangudhatakyadi Taila
2. Assessment of wound healing rate
|
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Comparison of wound healing activity of trial drug and control drug |
28 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 3 |
|
Date of First Enrollment (India)
|
25/06/2024 |
| 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
|
This randomized controlled clinical trial on chronic wound is with objectives of to assess the wound healing activity of Priyangudhatakyadi Taila, to assess the wound healing rate in 28 days and to compare wound healing activity of trial drug and control drug. Total 40 patients of chronic wounds will be registered irrespective of their gender and religion which are fulfilling the inclusion and exclusion criteria. Patients will be enrolled after thorough history taking, clinical examination, laboratory investigations on a specially prepared proforma. Registered patients will be randomly divided into two groups each contains 20 participants each. In trial group- After cleaning of wound with normal saline, gauze soaked with Priyangudhatakyadi Taila will be applied and in control group gauze soaked with Povidone iodine will be used followed by bandage once daily for 28 days or till the complete healing of wounds (whichever is earlier). It will be assessed by different parameters like wound characteristics (pain, wound bed, odor and granulation tissue), wound measurements (by linear measurement, serial photography and unit healing time), histopathological study and microbial load. At the end of the study, appropriate statistical test will be applied as per types of data. |