| CTRI Number |
CTRI/2024/07/069772 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/06/2024 |
| 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
|
A comparitive clinical study of povidine ointment and Vranaropani malahara on fresh wound |
|
Scientific Title of Study
|
A controlled clinical study to evaluate the efficacy of Vranaropani (Hemigraphis alternata (Burm.f)) Malahara in the management of sadyovrana. |
| 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 Surender Redhu |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College And Hospital, Moodbidri |
| Address |
OPD Department of Shalyatantra Alvas Ayurveda Medical
College And Hospital, Moodbidri
Dakshina Kannada
KARNATAKA
574227
India
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9466317930 |
| Fax |
|
| Email |
surenderredhu2014@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sajith M |
| Designation |
Professor |
| Affiliation |
Alvas Ayurveda Medical College And Hospital, Moodbidri |
| Address |
Department of Shalyatantra, Room no. 3 Alvas Ayurveda Medical College And Hospital, Moodbidri
Dakshina Kannada
KARNATAKA
574227
India
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7907569399 |
| Fax |
|
| Email |
drsajithayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surender Redhu |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College And Hospital, Moodbidri |
| Address |
OPD Department of Shalyatantra Alvas Ayurveda Medical
College And Hospital, Moodbidri
Dakshina Kannada
KARNATAKA
574227
India
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9466317930 |
| Fax |
|
| Email |
surenderredhu2014@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical College And Hospital, Moodbidri
Dakshina kannada
574227
India |
|
|
Primary Sponsor
|
| Name |
Dr Surender Redhu |
| Address |
Alvas Ayurveda Medical College And Hospital, Moodbidri
Dakshin kannada
574227
India |
| 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 Surender Redhu |
Alvas Ayurveda Medical College And Hospital, Moodbidri |
OPD Department of
Shalyatantra, room no. 2
Alvas
Ayurveda Medical
College And Hospital,
Moodbidri 574227
Dakshina Kannada
Karnataka
India
Dakshina Kannada
KARNATAKA |
9466317930
surenderredhu2014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Clinical Ethics Committee, Alvas Ayurveda Medical College And Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T148||Other injury of unspecified body region. Ayurveda Condition: SADYOVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Povidine ointment | povidine ointment application once per day for 15 days | | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: folklore medicine, Procedure details: application of ointment once per day)
(1) Medicine Name: vranaropani malahara, Reference: folklore medicine, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age group between 16 to 70 yrs.
Kshataja vrana, Chinna vrana.
Sadyovrana of following dimensions:
Maximum length 5 cm.
Maximum width: 5 cm
Maximum Depth: 0.5 cm.
Patients of either gender.
Wounds within 7 days. |
|
| ExclusionCriteria |
| Details |
Patients with systemic disorders like DM, HTN, Bleeding disorders and dermatological manifestations.
Wounds that require suturing.
Dushta Vrana (Infected).
The patients having Sadyovrana with other complications like fractures Marmaghata etc.
Medico-legal cases |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Check & Assess the Following Parameters
Size of wound.
Edema of the surrounding skin.
Time taken for wound healing.
Local raise of temperature.
|
15days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Check & Assess the Following Parameters
pain
burning sensation
|
15days |
|
|
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 3 |
|
Date of First Enrollment (India)
|
22/07/2024 |
| 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="3"
Days="7" |
|
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 - NO
|
|
Brief Summary
|
This study is randomized, parallel group, actively controlled clinical study with comparative standard study- Povidine Iodine and interventional drug- Vranaropani Malahara for lepa daily. The study is conducting on patients of sadyovrana belongs to age of 16years to 70years who gives written and verbal consent for undergoing clinical Study. Study will be conducting in Alvas Ayurveda Medical College And Hospital, Vidyagiri, Moodabidri. Interventional period of this study is 15 days assessment will be done on before treatment, 3rd,5th, 7th, 9th, 11th, 13th and 15th day. |