| CTRI Number |
CTRI/2019/01/017235 [Registered on: 24/01/2019] Trial Registered Prospectively |
| Last Modified On: |
20/11/2019 |
| 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 of Effect of Apamarga Ghrita in Wound Healing. |
|
Scientific Title of Study
|
Randomized controlled Study of Apamarga Ghrita on Utsadana Karma in Wound Healing with special reference to Collagen Synthesis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajkumar Tiwari |
| Designation |
M.S.(scholar) |
| Affiliation |
Government Ayurved college and hospital,Nagpur. |
| Address |
Room no.3,Shalyatantra Department,Government Ayurved college and hospital,Sakkardara chowk,Nagpur.
Nagpur
MAHARASHTRA
440024
India |
| Phone |
8369080295 |
| Fax |
|
| Email |
drtiwariraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raut SY |
| Designation |
Guide and HOD,Shalyatantra Department. |
| Affiliation |
Government Ayurved college and hospital,Nagpur. |
| Address |
Shalyatantra Department,Government Ayurved college and hospital,Sakkardara chowk,Nagpur.
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9422108928 |
| Fax |
|
| Email |
drsyraut@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raut SY |
| Designation |
Guide and HOD,Shalyatantra Department. |
| Affiliation |
Government Ayurved college and hospital,Nagpur. |
| Address |
Shalyatantra Department,Government Ayurved college and hospital,Sakkardara chowk,Nagpur.
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9422108928 |
| Fax |
|
| Email |
drsyraut@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Tiwari Rajkumar(Self),Dept of Shalyatantra,Govt Ayurved Hospital and Mahavidyalaya,Nagpur. |
|
|
Primary Sponsor
|
| Name |
Rajkumar Tiwari Self |
| Address |
Shalyatantra Department,Government Ayurved college and hospital,Nagpur. |
| 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 |
| Tiwari Rajkumar |
Government Ayurved college and hospital. |
Room no.3,Shalyatantra Opd,hospital division,Sakkardara chowk,Nagpur.
Nagpur
MAHARASHTRA |
8369080295
drtiwariraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee,Government Ayurved college and hospital,Nagpur. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T149||Unspecified injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Apamarga Ghrita |
Under all aseptic precautions wound will be cleaned by normal saline and Apamarga Ghrita will be applied,dressing will be done.Instructions to avoid infections will be given to patients. |
| Comparator Agent |
Povidone-Iodine Ointment |
Under all aseptic precautions wound will be cleaned by normal saline and povidone iodine ointment will be applied,dressing will be done.Instuctions to avoid infections will be given to patients. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having wound without any major illnesses.
2.wound of less than 24 hours duration are included.
3.Post operative wounds of Fistulectomy and Haemorrhoidectomy.
4.Traumatic wounds.
5.wound size of less than 49 square centimeter.
6.wounds without any major complications and cooperative patients will be taken for study. |
|
| ExclusionCriteria |
| Details |
1.Patient having any major illnesses.
2.patient having age less than 20 years and more than 60 years.
3.wound of more than 24 hours duration.
4.wound size more than 49 square centimeter.
5.Immunocompromised and non cooperative patients will be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessments of Utsadana karma done by Apamarga ghrita. |
0 day,5th day,10th day and 15th day.(For Total of 15 day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the effect of Apamarga Ghrita with Povidone iodine ointment on Utsadana karma. |
15 days |
| Review the literature through the Ayurvedic and modern classical text with recent research articles on Utsadana karma (Collagen Synthesis). |
1 month |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
25/01/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is A Randomized controlled clinical study of Apamarga Ghrita on Utsadana karma in wound healing with special refrence to Collagen Synthesis. wound healing is very complex process involving 4 phases including Haemostasis,Inflammation,Proliferation with collagen synthesis and Maturation.Acharya Sushruta described Shashti i.e. 60 Upkramas for vrana.In which Utsadana karma has its place inbetween Shodhana and Ropana. Apamarga ghrita,described by dalhana for Utsadana karma has been used traditionally in wound healing and in some vivo studies have showed increased number of fibrocytes, remarkable degree of neovascularization and epithelisation which is due to the increased collagen fiber and proteins. |