| CTRI Number |
CTRI/2025/04/084018 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
01/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [External application of churna ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the efficacy of external application of Guggulu Churna in healing of Dushta Vrana |
|
Scientific Title of Study
|
A randomized open controlled clinical study to evaluate the efficacy of Guggulu Avachurnan in the management of Dushta vrana with special reference to infected 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 Ritesh Hari Pawar |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Center Kodoli |
| Address |
OPD No 4 Shalyatantra department 2nd floor Yashwant Ayurvedic College Post Graduate Training and Research Center Tal Panhala
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9657798497 |
| Fax |
|
| Email |
riteshpawar51@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laxmi Maroti Narhare |
| Designation |
PG Guide |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Center Kodoli |
| Address |
OPD No 4 Shalyatantra department 2nd floor Yashwant Ayurvedic
College Post Graduate Training and Research Center, Tal Panhala,
Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822189226 |
| Fax |
|
| Email |
drlaxminarhare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laxmi Maroti Narhare |
| Designation |
PG Guide |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Center Kodoli |
| Address |
OPD No 4 Shalyatantra department 2nd floor Yashwant Ayurvedic
College Post Graduate Training and Research Center, Tal Panhala,
Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822189226 |
| Fax |
|
| Email |
drlaxminarhare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Daily OPD, IPD And Casualty Patients Yashwant Ayurvedic Medical college kodoli kolhapur 416414Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Ritesh Hari Pawar |
| Address |
OPD No 4 Shalyatantra department 2nd floor Yashwant Ayurvedic College Post Graduate Training and Research Center, Tal Panhala , Dist Kolhapur Kolhapur MAHARASHTRA 416114 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 Ritesh Hari Pawar |
Yashwant Dharmartha Rugnalay Kodoli |
Opd no 4 Shalyatantra department 2nd floor Yashwant Ayurvedic College Post Graduate Training and Research Center, Kodoli
Kolhapur
MAHARASHTRA |
9657798497
riteshpawar51@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Yashwant Ayurvedic College PGT& RC Kodoli |
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: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Avachurnan | (Procedure Reference: Bhel samhita chikitsa sthan, Procedure details: Wash the wound properly by normal Saline.
Gugguluchurna will be dusted over the affected area uniformly Once daily)
(1) Medicine Name: Guggulu, Reference: Bhel samhita chikitsa sthan, Route: Topical, Dosage Form: Churna/ Powder, Dose: 00(NA), Frequency: od, Duration: 15 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Povidone iodine powder and H2O2 | Clean the wound by hydrogen peroxide.
Application of povidone-iodine powder over wound |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Dushta-vrana with dimensions measuring as Length upto 5cm, Breadth upto 5cm and depth upto 1cm.
Age-From 18 yrs to 65 yrs
Patients Irrespective of Gender, Economic Class, Caste, Religion,
Patients NOT suffering from any severe Systemic Diseases. |
|
| ExclusionCriteria |
| Details |
Patients having dushta vrana which measure more than 5 X 5 X 1 cms surface area
Patient suffering from
Systemic disease such as uncontrolled diabetes mellitus uncontrolled hypertension Hepatitis B
Malignancy leukemia Kochs Vericose ulcer Deep Vein Thrombosis Arterial ulcer Neurogenic Ulcer Leprosy
Pregnancy Acute and chronic renal failure liver cirrhosis
Burn ligament tear tendon tear fracture
Anaemia malnutrition
Known case of HIV HCV HbsAg positive paitent
Wounds having excessive loss of tissue |
|
|
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 |
| To assess the effect of Guggulu Avachurnan in Dushtavrana with special reference to infected wound. |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the probable mode of action of Guggul Avachurnan in dushtavrana.
To reduce discomfort and complaints of patients.
To assess improvement by signs, prognosis and gradation of assessment criteria.
To achieve the outcome of study in 15 days |
15 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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/04/2025 |
| 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 Applicable |
| 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-identiļ¬cation.
- What additional supporting information will be shared?
Response - Informed Consent Form
- 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 (Others) -
- For how long will this data be available start date provided 10-04-2025 and end date provided 09-04-2029?
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
|
A randomized open controlled clinical study to evaluate the efficacy of Guggulu Avachurnan in the management of Dushta Vrana with special reference to Infected Wound Assessment of sign and symptoms will be done on follow up days and outcome will be assessed after 15 days |