| CTRI Number |
CTRI/2024/12/078764 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| 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
|
Wound Healing Activity of a Traditional Vranaropak Formulation |
|
Scientific Title of Study
|
Preclinical and Clinical Study to Evaluate the Vranaropana Karma (Wound Healing Activity) of Sarala (Pinus roxburghii Sargent) Exudate |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amit Kumar Taraphdar |
| Designation |
Professor Department of Dravyaguna IPGAER at SVSP Hospital |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
| Address |
Dept. of Dravyaguna, Room no T2, IPGAER at SVSP Hospital, 294/3/1 A.P.C Road, Kolkata
294/3/1 A.P.C Road, Kolkata-700009
Kolkata
WEST BENGAL
700009
India |
| Phone |
9874849650 |
| Fax |
|
| Email |
atipgaer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Kumar Taraphdar |
| Designation |
Professor Department of Dravyaguna IPGAER at SVSP Hospital |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
| Address |
Dept. of Dravyaguna, Room no T2, IPGAER at SVSP Hospital, 294/3/1 A.P.C Road, Kolkata
294/3/1 A.P.C Road, Kolkata-700009
Kolkata
WEST BENGAL
700009
India |
| Phone |
9874849650 |
| Fax |
|
| Email |
atipgaer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Beauty Maity |
| Designation |
MD Scholar Dept of Dravyaguna IPGAER at SVSP Hospital |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
| Address |
Dept of Dravyaguna, Room no T2, IPGAER at SVSP Hospital, 294/3/1 A.P.C Road, Kolkata
294/3/1 A.P.C Road, Kolkata-700009
Kolkata
WEST BENGAL
700009
India |
| Phone |
7890184704 |
| Fax |
|
| Email |
beautymaity592@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apothecary Dept. of Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital, 294/3/1 A.P.C Road, Kolkata-700009, West Bengal, India |
|
|
Primary Sponsor
|
| Name |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
| Address |
294/3/1 A.P.C Road, Kolkata-700009, West Bengal, India |
| Type of Sponsor |
Government 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 Amit Kumar Taraphdar |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
Room No. T2, Dept. of Dravyaguna, 294/3/1 A.P.C Road, Kolkata- 700009
Kolkata
WEST BENGAL |
9874849650
atipgaer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee for Clinical Trial on Human Subjects, IPGAER, Kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T149||Unspecified injury. Ayurveda Condition: VRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sarala (Pinus roxburghii) exydate, Reference: Bhavaprakasa Nighantu, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 00(NA), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: Dose of test drug- Quantity sufficient for local application, twice daily for 28days | | 2 | Comparator Arm (Non Ayurveda) | | - | Drug | Mupirocin 2% w/w ointment, Topical Antibiotic, Dose- Quantity sufficient for local appliction twice daily for 28days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The clinical study will be single blind clinical study, with two groups of patients (male and female both) suffering from acute wound, partial fistulectomy wound in the OPD and IPD of the hospital at IPGAER, Kolkata |
|
| ExclusionCriteria |
| Details |
1. Age below 20years or above 60years
2. Pre-existing diabetes mallitus
3. History of severe trauma
4. Pregnancy and lactating mother
5. Excessive P/R bleeding
6. Sexually transmitted disease
7. Malignancy
8. Patient with H/O multiple surgical intervention |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The safety and clinical efficacy of the test drug by monitoring the wound area, wound appearance, TC, DC, ESR, Hb% |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safe, Effective, Economical wound healing ayurvedic drug for the suffering patients |
28 days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
20/01/2025 |
| 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="0"
Months="8"
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 clinical study, which will take place at the OPD of the IPGAER at SVSP Hospital, is a randomized, parallel-grouped control trial of a test drug comparing the safety and efficacy of Mupirocin for 28days in 20 patients suffering from different type of wounds. The primary outcome of this research is to evaluate the therapeutic efficacy of the test drug for its potential wound healing activity. The secondary outcome is to determine the safety of the test drug on quality of life among the patients suffering from different dermal injury. |