| CTRI Number |
CTRI/2025/10/096635 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Natural herbal powder with dhataki and lodhra for healing and cleaning infected wounds |
|
Scientific Title of Study
|
Healing and antimicrobial effect of avachoornana with dhataki and lodhra in dushtavrana |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Fathima suhana ck |
| Designation |
P G scholar |
| Affiliation |
Govt. Ayurveda college Pariyaram Kannur |
| Address |
Department of salyatantra Govt. Ayurveda college Pariyaram Kannur
Kannur
KERALA
670503
India |
| Phone |
9496082177 |
| Fax |
|
| Email |
dr.suhanafathima@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sreelekha M P |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Govt. Ayurveda college Pariyaram Kannur |
| Address |
ASSOCIATE PROFESSOR DEPARTMENT OF SHALYATANTRA GOVT AYURVEDA COLLEGE PARIYARAM KANNUR
Kannur
KERALA
670503
India |
| Phone |
7025458190 |
| Fax |
|
| Email |
sreelekaprasanth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Fathima suhana ck |
| Designation |
P G scholar |
| Affiliation |
Govt. Ayurveda college Pariyaram Kannur |
| Address |
Department of salyatantra Govt. Ayurveda college Pariyaram Kannur
Kannur
KERALA
670503
India |
| Phone |
9496082177 |
| Fax |
|
| Email |
dr.suhanafathima@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR Fathima suhana c k |
| Address |
P G Scholar department of salyatantra Govt Ayurveda college Pariyaram Kannur PIN 670503
|
| 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 Fathima suhana ck |
Govt Ayurveda college Pariyaram Kannur |
OPD of Department of salyatantra Govt Ayurveda college Pariyaram Kannur PIN 670503
Kannur
KERALA |
09496082177
dr.suhanafathima@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT AYURVEDA COLLEGE PARIYARAM KANNUR PIN 670503 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I00-I99||Diseases of the circulatory system. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | avacUrNan , अवचूर्णन | (Procedure Reference: Susruta samhita, Procedure details: With all aseptic measures, the ulcer will be cleaned with distilled water Using the swab mop the area of the ulcer & a dusting with dhataki & lodhra choorna of sufficient quantity will be carried out Then cover the ulcer with gauze & bandaging was done & retained for the entire one day till next bandaging )
|
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with signs and symptoms of non healing ulcer
Wound size less than 10 cm length and 10 cm width
|
|
| ExclusionCriteria |
| Details |
Known case of tuberculosis malignancy burn and uncontrolled diabetes mellitus
Known case of HIV hepatitis B or other sexually transmitted infection
Gangrenous ulcer malignant ulcer and trophic ulcer |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Size of the wound
Microbial load assessment
Amount of discharge
Granulation tissue formation
Pain |
Assessed on 1st 7th 14th 21st and 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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
|
N/A |
|
Date of First Enrollment (India)
|
09/11/2025 |
| 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="0"
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 - NO
|
|
Brief Summary
|
This clinical study aim to evaluate the effect of avachoornana with dhataki and lodhra in dushtavrana.On the basis of clinical features non healing ulcers can be considered as dushtavrana. This is single group pre and post interventional study and the sample size is 26 are taken from the outpatient department of Shalyatantra Government Ayurveda College Kannur. Assessment will be done based on objective and subjective parameters such as pain wound size discharge microbial load and improving granulation tissue formation. |