| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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 | | 2 | Comparator Arm (Non Ayurveda) | | - | Standard Sterile Gauze Dressing | WHO 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 |
|
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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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [usmandhange@gmail.com].
- 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.
- 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. |