| CTRI Number |
CTRI/2023/01/048934 [Registered on: 11/01/2023] Trial Registered Prospectively |
| Last Modified On: |
08/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Wound management with Ayurvedic formulation |
|
Scientific Title of Study
|
Development and Evaluation of Palasha (Butea monosperma Lam) Twak Extracted Ointment in Shuddha Vrana A Randomized Controlled Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bolaj Sheetal Kumar |
| Designation |
PG scholar |
| Affiliation |
KLE Belagavi |
| Address |
OPD No 08 Dept of Shalya Tantra KLE Ayurveda Hospital Shahapur Belagavi Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
9284311439 |
| Fax |
|
| Email |
pg21sbolaj@kleayurworld.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laxmikant |
| Designation |
Professor |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya Belagavi KRNATAKA |
| Address |
c/o Shalya Tantra Department KAHERs Shri BMK Ayurveda Mahavidyalaya Belagavi KRNATAKA
Belgaum
KARNATAKA
590003
India |
| Phone |
9480007651 |
| Fax |
|
| Email |
shalyalsd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laxmikant |
| Designation |
Professor |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya Belagavi KRNATAKA |
| Address |
c/o Shalya Tantra Department KAHERs Shri BMK Ayurveda Mahavidyalaya Belagavi KRNATAKA
Bagalkot
KARNATAKA
590003
India |
| Phone |
9480007651 |
| Fax |
|
| Email |
shalyalsd@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs shri BMK ayurveda mahavidyalaya shahapur belagavi karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Bolaj Sheetal |
| Address |
PG Scholar department of shalya tantra KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka |
| 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 Bolaj Sheetal |
KLE Ayurveda Hospital |
KLE Ayurveda Hospital Shahapur Belagavi
Belgaum
KARNATAKA |
9284311439
pg21sbolaj@kleayurworld.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T149||Unspecified injury. 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: Palasha Twak extracted ointment, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | povidone iodine ointment | required quantity will be applied once daily for 14 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1) Either sex between 10-75 years of age.
2) Patients with the Lakshana of SHUDDHA VRANA.
|
|
| ExclusionCriteria |
| Details |
Patients with known case of Type II DM TB HbsAg HIV I & II varicose ulcer malignant wounds |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Palsaha Twak extracted ointment heals Shuddha Vrana |
baseline is 8th day and 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Palsaha Twak extracted ointment may heals Shuddha Vrana based on Bates Jensen criteria |
baseline on 15th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/07/2023 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is randomized controlled clinical trial to develop and evaluate the efficacy of palash twak extracted ointment in shuddha vrana and to compare with iodine pivodine ointment for period of 14 days. study will be conducted in kaher’s shri bmk ayurveda hospital in shalyatantra opd and ipd. |