| CTRI Number |
CTRI/2023/02/049990 [Registered on: 22/02/2023] Trial Registered Prospectively |
| Last Modified On: |
22/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative study of effect of application of Thumari (Securinega Leucopyrus) Ointment and Betadine Ointment Management on Shastrakruta Vrana (Surgical Wounds) |
|
Scientific Title of Study
|
Comparative Evaluation of efficacy of application of Thumari (Securinega Leucopyrus) Ointment versus Betadine Ointment in the Management of Shastrakruta Vrana (Surgical Wounds) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devesh Hetram Nagpure |
| Designation |
PG Scholar |
| Affiliation |
Datta Meghe Institute of Higher Education And Research |
| Address |
Room Number 13 Shalya Tantra OPD Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9579207278 |
| Fax |
|
| Email |
deveshbmw@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sheetal Asutkar |
| Designation |
Head Of Department of Shalyatantra |
| Affiliation |
Datta Meghe Institute of Higher Education And Research |
| Address |
Room Number 13 Shalya Tantra OPD Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9766811974 |
| Fax |
|
| Email |
sheetalasutkar16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devesh Hetram Nagpure |
| Designation |
PG Scholar |
| Affiliation |
Datta Meghe Institute of Higher Education And Research |
| Address |
Room Number 13 Shalya Tantra OPD Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9579207278 |
| Fax |
|
| Email |
deveshbmw@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education And Research |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education And Research |
| Address |
Mahatma Gandhi Ayurved College Hospital And Research Centre Salod Hirapur Wardha |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Devesh Hetram Nagpure |
Mahatma Gandhi Ayurved College Hospital And Research Centre |
Room Number 13 OPD Shalyatantra Departmrnt Mahatma Gandhi
Ayurved College
Hospital And Research
Centre Salod Hirapur Wardha
Wardha
MAHARASHTRA |
9579207278
deveshbmw@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: VRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Thumari Ointment, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 2 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Povidone Ointment |
POVIDONE IODINE is used on the skin to decrease risk of infection. This medicine is also used as a surgical hand scrub and to wash the skin and surface of the eye before surgery to help prevent infections. |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Post-Operative patients aged between 18 years to 60 years.
2.Patients will be selected with Shashtrakruta Vrana (Surgical Wound) irrespective of sex, religion, & socio-economical class.
3.H.I.V. positive patients.
4.T.B. positive patients.
5.Controlled D.M. patients.
6.Patients who give written informed consent for the clinical trial.
|
|
| ExclusionCriteria |
| Details |
1. Surgical Malignancy cases.
2. Severely Infected cases.
3. Patients who are not willing to participate in the trial.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wound Healing And Analgesia Of Shastrakruta Vrana |
14 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No Scar Formation |
28 Days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2023 |
| 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)?
Response - NO
|
Brief Summary
Modification(s)
|
Sadyovrana mostly occurs due to accidental injuries &Shastrakruta (surgical wound). As we see in today’s world the number of major & minor injuries has increased. xThe prevalence of Surgical Site Infection in India varies from 23% to 38%, inspite of using antibiotics.Side effects of Betadine Ointment include skin irritation and sometimes swelling.[6]So a better alternative for wound healing and management of secondary infection is the need of the hour. Thumari gel, Thumari oil and Thumarikalka are already proven best for wound healing, anti-inflammatory, analgesic, antibacterial and antifungal activity by many researchers in DushtaVrana, Diabetic wound, Beurger’s disease, Bed sores, Stanagatvrana . Thumari has best wound healing activity and it has antibacterial and antifungal activities as well to avoid or decrease secondary infection rate, Thumari ointmnet can be an excellent. Thumari contains Tannins-Wound Healing and flavanoids-antioxidant.Thumari Ointment promotes early healing of wounds and it can be a substitute of Povidone Ointment.
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