| CTRI Number |
CTRI/2024/09/073342 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| 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
|
To study the efficacy Of Darvyadi Ghrita in Sadyovrana with special reference to Traumatic Wound. |
|
Scientific Title of Study
|
Randomized Controlled Clinical Study To Evaluate The Efficacy Of Darvyadi Ghrita In The Management Of Sadyovrana With Special Reference To Traumatic Wound . |
| 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 Lancy Daniel Bardeskar |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur, Department of Shalyatantra, Division No 1, Room no 1, Tal-Walwa,Dist-Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9421076833 |
| Fax |
|
| Email |
lancydb11198@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Ramachandra Shedge |
| Designation |
HOD Professor in Shalyatantra Department |
| Affiliation |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur, Department of Shalyatantra, Division No 1, Room No 1, Tal-Walwa, Dist-Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
8888944733 |
| Fax |
|
| Email |
amit.shedage12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Ramachandra Shedge |
| Designation |
HOD Professor in Shalyatantra Department |
| Affiliation |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur, Department of Shalyatantra, Division No1 , Room No 1, Islampur, Tal-Walwa, Dist-Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
8888944733 |
| Fax |
|
| Email |
amit.shedage12@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College and Hospital and Research Centre, Islampur, Tal-Walwa, Dist-Sangli, State-Maharashtra, Country-India,Pincode-415409 |
|
|
Primary Sponsor
|
| Name |
Dr Lancy Daniel Bardeskar |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Reasearch Centre Islampur Sangli |
| 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 Lancy Daniel Bardeskar |
LRP Ayurvedic Medical College and Hospital |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre, Department of Shalyatantra, Division No 1, Room No 1, Islampur,Tal-Walwa, Dist -Sangli
MAHARASHTRA
415409
INDIA
Sangli
MAHARASHTRA |
9421076833
lancydb11198@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: SADYOVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Dressing | (Procedure Reference: Bhaishajya Ratnavali 47/79, Procedure details: Vrana prakshalan will be done with normal saline. Dust or any other foreign particles will be removed, then sufficient amount of Ghrita lepana will be done on wound with a help of sterile dressing pad having length & breadth which will cover the wound area. Proper dressing will be done with sterile bandage cloth. This procedure will be repeated daily for 7 days. )
(1) Medicine Name: Durvadi ghrita, Reference: Bhaishajya Ratnavali 47/79, Route: Topical, Dosage Form: Ghrita, Dose: 05(ml), Frequency: od, Duration: 07 Days | | 2 | Intervention Arm | Procedure | - | Dressing | (Procedure Reference: Gadnigraha adhyay 39/60, 61, Procedure details: Vrana prakshalan will be done with normal saline. Dust or any other foreign particles will be removed, then sufficient amount of Ghrita lepana will be done on wound with a help of sterile dressing pad having length & breadth which will cover the wound area. Proper dressing will be done with sterile bandage cloth. This procedure will be repeated daily for 7 days.
)
(1) Medicine Name: Darvyadi ghrita, Reference: Gadnigraha adhyay 39/60, 61, Route: Topical, Dosage Form: Ghrita, Dose: 05(ml), Frequency: od, Duration: 07 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having Sadyovrana of duration less than 6hrs
2.Patients having sadyovrana related to twaka and mansa only
3.Sadyovrana having size Max length - 6cm
Max width - 6cm
Max depth - 5mm
4.Patients irrespective of Caste, religion, sex, economical status, Occupation etc |
|
| ExclusionCriteria |
| Details |
1)Patient with sadyovrana of duration more than 6 hrs.
2)Known uncontrolled diabetic patients, HIV, HBsAg and other systemic diseases.
3)The patient having sadyovrana with other complications like fracture or any other venous or arterial disease.
4)Sadyovrana having medico legal problems.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Study to assess the efficacy of Darvyadi Ghrita in management of Sadyovrana with special reference to traumatic wound in age group of 16 to 70 years for 15 days |
15 days study includes follow up on 0th,1st,2nd,3rd,4th,5th,6th,10th and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of Darvyado ghrita in the management of Sadyovrana with special reference to traumatic wound
To reduce the symptoms of Sadyovrana |
15 days study with follow up on 10th & 14th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
14/09/2024 |
| 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="0"
Months="6"
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
|
A wound is a break in the integrity of the skin or tissues often which may be associated with disruption of the structure and function . In a medical practice healing of wound in short period of time is very important factor. In healthy way at wound site and it takes lots of time for skin to regain its natural state. Even though healing of wound is natural process of body Acharya Yogaratnakar has described Sadyovrana in Sadyovrana nidan adhyay. Healing is a natural restorative response to tissue injury .Healing is the intereaction of a complex cascades of cellular events that generates resurfacing, reconstruction and restoration of the tensile strength of injured skin. Healing is a systemic process ,traditionally explained in terms of three classic phases viz Infammation, Proliferation and Maturation . A clot forms an inflammatory cells, debride injured tissue during the inflammatory phase. Epithelialization, fibroplasia and angiogenesis occur during the proliferative phase .Meanwhile,granulation tissue forms and wound begin to contract . Finally during the maturation phase, collagen forms tight cross lines to other collagen and with protein molecules, increasing the tensile strength of the scar. Wound healing is a process in which the skin and the tissue under it repair themselves after injury. As the sciences advanced new therapies are described out for recovery of wound . Acharya Sushruta explained various kalpa for management of vrana also he explained 60 different regimes for the purpose of wound healing . They cover all the aspect of wound healing so in this study we are going to highlighting one of the kalpana fron Gadnigraha samhita . Among the samhita Gadnigraha has explaine Darvyadi Ghrita in Visarpa adhyay for ropan chikitsa . The major aspect of management of fresh wound is prevention of the infection and speedy healing. Reducing pain, discharge and less discolouration after healing are the other important factors. The proper initial care of the fresh wound will definitely prevent inadvertent use of the oral and systematic antibiotics. We have invented many antiseptic agents for local application to prevent the contamination of the wound along with many oral antibiotics. Oral and local antibiotics prevent infection but have no role to accelerate the natural healing process. In Sadyovrana Ropan chikitsa is important thats why vrana ropak ghrita is important and effective alternative formulation. Acharya Vaghbhata has described it to have great healing properties which are useful to mankind. Vaghbhata has described to have great healing and binding property and also he described the Sanskaranuvartana guna of Ghrita . The ingrediants of Darvyadi Ghrita are as folloiws - Daruharidra,Yasthimadhu, Lodhra, Nagkeshar, Patole patra and Triphala in which active principle of those drugs get useful in management of Ropan effect more in Sadyovrana. Taking all these consideration , I have selected Darvyadi Ghrita which has special reference of giving it in Sadyovrana . his ghrita is easily available and economically affordable . |