| CTRI Number |
CTRI/2022/11/047771 [Registered on: 29/11/2022] Trial Registered Prospectively |
| Last Modified On: |
28/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Trial To Study The Efficacy Of Madhusarpi In The Management Of Shastrakrut Vrana. |
|
Scientific Title of Study
|
A Randomised Standard Controlled Clinical Trial To Assess The Efficacy Of Madhusarpi In The Management Of Shastrakrut Vrana. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajit Hanmant Gaikwad |
| Designation |
PG scholar |
| Affiliation |
PDEAS College of Ayurved and Research Centre , Nigadi Pune |
| Address |
PDEAS College of Ayurved and Research Centre, Third floor,
Shalyatantra department Sector no. 25 Nigdi Pradhikaran, Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
8888990206 |
| Fax |
|
| Email |
gaikwadajit667@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhavi S Banarase |
| Designation |
HOD Shalyatantra Department |
| Affiliation |
PDEAS College of Ayurved and Research Centre , Nigadi Pune |
| Address |
PDEAS College of Ayurved and Research Centre, Third floor,
Shalyatantra department , Sector no. 25 Nigdi Pradhikaran, Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
9423207569 |
| Fax |
|
| Email |
dr.madhavibanarase209@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajit Hanmant Gaikwad |
| Designation |
PG Scholar |
| Affiliation |
PDEAS College of Ayurved and Research Centre |
| Address |
PDEAS College of Ayurved and Research Centre, Third floor,
Shalyatantra department , Sector no. 25 Nigdi Pradhikaran, Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
08888990206 |
| Fax |
|
| Email |
gaikwadajit667@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAS College of Ayurved and Research Centre, sec.no.25 pradhikaran Nigdi Pune 411044 |
|
|
Primary Sponsor
|
| Name |
PDEAS College of Ayurved and Research Centre Nigadi Pune |
| Address |
PDEAS College of Ayurved and Research Centre,Sec.no.25 Pradhikaran Nigdi Pune 411044 |
| 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 Ajit Hanmant Gaikwad |
Ayurved Rugnalay and Sterling Multispeciality Hospital, Nigdi Pradhikaran, Pune |
Vitthal Rukmini road sector no 27,Shalya OPD 123, Nigdi Pradhikaran Pune
Pune
MAHARASHTRA |
8888990206
gaikwadajit667@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L768||Other intraoperative and postprocedural complications of skin and subcutaneous tissue, (2) ICD-10 Condition:L768||Other intraoperative and postprocedural complications of skin and subcutaneous tissue. Ayurveda Condition: Shastrakrut vrana , (3) ICD-10 Condition:L768||Other intraoperative and postprocedural complications of skin and subcutaneous tissue. Ayurveda Condition: Shastrakrut vrana , |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Madhusarpi, Reference: Kavi.Dr.Ambikadatta Shastri, Sushruta Samhita Reprint 2014, varanasi, Choukhamba Bharati Academy, 2014.chikitsastan page no 16 shlok 130, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: On the first day before application of Madhusarpi on the wound,
wound was cleaned with normal saline , applied locally on the wound by soaking the sterile
cotton gauze into it. Dressing every alternate day done. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yashtimadhu siddha ghrita , Reference: Kavi.Dr.Ambikadatta Shastri, Sushruta Samhita Reprint 2014, varanasi, Choukhamba Bharati Academy, 2014.chikitsastan page no.27 shlok 42, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: -On the first day before application of Yashtimadhusidddha Ghrita
on the wound, wound was cleaned with normal saline.
Yashtimadhusiddha Ghrita applied locally on the wound by
soaking the sterile cotton gauze into it. . Dressing every alternate
day done. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients Who are having
1.CLW after suturing
2.Age between 20- 60 yr
3.Clean shastrakrut vrana after suturing |
|
| ExclusionCriteria |
| Details |
K/C/O
1.DM
2.Gangrene
3.malignancy
4.Abscess
5.Infected wound
6.Severely anemic patients
7.any severe systemic illness |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
- To identify the diffrence of treatments for the management of shastrakrut vrana.
- To observe and compare the effectiveness of treatments over the period of time .
- To compare the efficacy of trial group drug and controle group drug that is
Madhusarpi for trial grouo and Yashtimadhusiddha ghrita for conttole group in the management of shastrakrut vrana ( post operative sutired wound).
|
Total 10 days treatment.
Baseline(0 Day), 2nd Day, 4th Day,6th Day, 8th Day, 10th Day
To observe the wound healing process on 2nd, 4th, 6th, 8th, 10th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- To observe the effect on wound healing by Local apllication of madhusarpi on shastrakrut vrana (Trial Group ) and Local apllication of yashtimadhu siddha ghrita ( Control group ) on shastrakrut vrana , And compare them .
-To find the effect on wound healing .
- To assess the adverse effect of treatment, if any |
Total 10 days treatment.
Baseline(0 Day), 2nd Day, 4th Day,6th Day, 8th Day, 10th Day
To observe the wound healing process on 2nd, 4th, 6th, 8th, 10th Day |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2022 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomised controlled clinical trial to assess the efficacy of madhusarpi in the management of shastrakrut vrana . In this study we are going to see whether madhusarpi for Trial group and yashtimadhusiddha ghrita for control group which one is doing well in wound healing process.. Shastrakrut vrana is type of sadyaovrana Shastrakrut vrana is done using surgical knife, blade , postoperative wound . In this study we are selecting patient who is between age group of 20-60 years, both male and female . Those patient who have post operative sutured wound , that patient are selected for study . All ingredients of Madhusarpi are easily available and cost effective Multiple modern drugs are available but they are associated with some side effects. No previous work done on Comparison of Madhusarpi with Yashtimadhusiddha Ghrita till date, so this drug & disease combination has been selected for the research topic. The Role Of MADHUSARPI WITH YASHTIMADHUSIDDHA GHRITA IN MANAGEMENT OF SHASTRAKRUT-VRANA Local application treatment, very much effective in sadyo- vranaropan. Further, the post-surgical complications such as prevent infection of Post-operative wound, or of fresh sutured wound. However, Local application procedure is simple, easy, safe, feasible and equally effective in the management of Shastrakrut vrana as compared to other. To make it suitable madhusarpi local application will be used. Hence study to evaluate the effect of madhusarpi local application in the managment of Shastrakrut Vrana, Therefore this formulation has been choosen for present study |