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CTRI Number  CTRI/2024/12/078047 [Registered on: 12/12/2024] Trial Registered Prospectively
Last Modified On: 11/12/2024
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   Using Aksheevadi Ghrita impregnated Tulle dressing for managing Sadhyo-Vrana in clean surgical wound  
Scientific Title of Study   Open Randomized Controlled Clinical Study To Evaluate The Efficacy Of Aksheevadi Ghrita Impregnated Tulle In the Management Of Sadyo Vrana W.S.R Surgical 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 Usman Gani Aves Dhange 
Designation  P G Scholar  
Affiliation  D.Y.Patil School of Ayurveda, Nerul, Navi Mumbai 
Address  401/4th floor Suryoday Building Dongri Umerkhadi Opposite ST Joseph High School

Mumbai
MAHARASHTRA
400009
India 
Phone  9158226137  
Fax    
Email  usmandhange@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amarprakash Dwivedi 
Designation  M.S shalyatantra PhD Ayu 
Affiliation  D.Y.Patil School of Ayurveda, Nerul, Navi Mumbai 
Address  School of Ayurveda D Y Patil Deemed to be University Sector 7 Navi Mumbai Maharashtra India

Thane
MAHARASHTRA
400706
India 
Phone  9022325666  
Fax    
Email  amar.dwivedi@dypatil.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Usman Gani Aves Dhange 
Designation  P G Scholar  
Affiliation  D.Y.Patil School of Ayurveda, Nerul, Navi Mumbai 
Address  401/4th floor Suryoday Building Dongri Umerkhadi Opposite ST Joseph High School


MAHARASHTRA
400009
India 
Phone  9158226137  
Fax    
Email  usmandhange@gmail.com  
 
Source of Monetary or Material Support  
D Y Patil Ayurvedic Hospital Sector 7 Nerul Navi Mumbai Maharashtra pin code 400706 India 
 
Primary Sponsor  
Name  Dr Usman Gani Aves Dhange 
Address  Dr D Y Patil Ayurvedic Hospital Sector 7 Nerul Navi Mumbai Maharashtra 400706 
Type of Sponsor  Other [self sponsored ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Usman Gani Aves Dhange  Dr D Y Patil Ayurvedic Hospital  Shalyatantra department Shalyatantra opd - 3 on first floor and the Shalyatantra male and female wards on first floor
Thane
MAHARASHTRA 
9158226137

usmandhange@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee D Y Patil Deemed to be University School of Ayurveda Nerul Navi Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:Z480||Encounter for attention to dressings, sutures and drains. Ayurveda Condition: SADYOVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Aksheevadi Ghrita, Reference: Vaidya Manorama (Chapter 16/117, page-177 in Akshikarnavranagranthi chikitsha Adhyaya), Route: Topical, Dosage Form: Ghrita, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: Impregnated tulle gras dressing with Aksheevadi Ghrita for surgical wound dressing
2Comparator Arm (Non Ayurveda)-Standard Sterile Gauze DressingWHO standard post-operative wound dressing - Basic Wound Contact Dressing used for use on primarily closed incisions.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Wound type Sadyovrana 1 Aghataj Shuddha Vrana Traumatic non infected wounds
(CLW size upto 6cm)

Shastrakruta Vrana -Surgical wounds (minor surgical cases

such as fissure lipoma cyst fistula dermoid cyst pedunculated growths etc)
Other specifications
Patient taken who will be operated under short GA local Saddle block Anesthesia 
 
ExclusionCriteria 
Details  Patients having systemic disorders such as Diabetes Tuberculosis Leprosy Malignancies.
Immunocompromised patients diagnosed with HIV HBsAg HCV and VDRL positive.
Infected non healing wounds and burn wounds
Patients with Venous Arterial ulcer (Vascular ulcer) pressure ulcers.
Wounds having deep tissue involvement like muscle bone tendon viscera.
Dropouts Patients discontinued follow up 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of Aksheevadi Ghrita impregnated tulle (AyuGras) in the management of Surgical wounds using REEDAs assessment scale which includes Pain Redness oedema ecchymosis discharge and approximation of surgical wound at day 1 day 3 day day 5 day 7 and day 10  assessment of surgical wound healing REEDAs assessment scale at day 1 day 3 day day 5 day 7 and day 10 
 
Secondary Outcome  
Outcome  TimePoints 
To provide sterile herbal dressing formulation in surgical wound management  by clinical prospective study assessing surgical wound healing using REEDAs assessment scale at day 1 day 3 day day 5 day 7 and day 10 and observing adverse effect of the formulation if any in the next 30 days 
 
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/ Phase 3 
Date of First Enrollment (India)   23/12/2024 
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 Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [usmandhange@gmail.com].

  6. For how long will this data be available start date provided 12-12-2024 and end date provided 12-12-2025?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Post-operative wound care is of prime importance after a successful operative procedure. In post-operative wound care the wound must be kept in a sterile environment as chance of infections are very high because of the exposed epithelium, as well as the granulation tissue needs to be kept under constant monitoring. Daily dressing and proper wound care is of prime importance in early stages as it helps in safer and faster healing. In modern practice we use dressing materials such as plain sterile gauzes, tulle gauzes impregnated with various anti-bacterial agents and ointments for local application.Each of the preparations and method of dressing
varies based on type, site and nature of pathogens, etc. involved in formation of wound.
Similarly in Ayurveda the concept of vikeshika has been mentioned for wound management but this does not have Krimighna property or anti-microbial property of its own. Merging the concept of vikeshika and Ghrita siddhi together we are making vikeshika impregnated with herbal medicated Ghrita that will be a ready formulation for dressing. Shigru and Yashtimadhu both plants have anti-bacterial, antifungal, anti-gastric, analgesic, anti-inflammatory, and wound healing properties and have been clinically proven in several research studies. Significant research on Shigru and Yashtimadhu has been conducted in the past but their role in wound care isn’t highlighted enough even after having all the successful qualities for wound care management, such as anti-bacterial, antifungal anti- inflammatory properties.
Hence, Method of preparation plays a crucial role in preparing a sterile dressing material especially in dressing of post operated wounds. We have hence tried to bridge the gap between modern and Ayurvedic system of medicine by preparing a herbal Ghrita impregnated sterile tulle for dressing of surgical wound which will be readily accepted due to its standardized method of preparation and sterility. The formulation will be sterile, disposable, cost effective & completely herbal preparation for surgical wound. The efficacy of this formulation (herbal impregnated tulle) will be assessed by using standard REEDs for surgical wound healing. It is an open randomized controlled clinical trial designed to evaluate the efficacy of the same.  
 
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