| CTRI Number |
CTRI/2020/09/027706 [Registered on: 10/09/2020] Trial Registered Prospectively |
| Last Modified On: |
08/09/2020 |
| 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
|
To see the effect of kakubhadi ointment in wound healing. |
|
Scientific Title of Study
|
Clinical Evaluation of Ropana Effect of Kakubhadi Ointment in Shuddha Vrana |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nilam kisan Bahiram |
| Designation |
P G scholar |
| Affiliation |
Ayurved seva sangh,Ayurved mahavidyalaya,nashik |
| Address |
OPD no 6 Shalyatantra OPD
Nashik
MAHARASHTRA
422003
India |
| Phone |
8623946284 |
| Fax |
02532517170 |
| Email |
neelambahiram13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinay Sonambekar |
| Designation |
Professor and Guide |
| Affiliation |
Ayurved seva sangh,Ayurved mahavidyalaya,nashik |
| Address |
Ayurved seva sangh ayurved mahavidyalaya panchavati nasik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9822624890 |
| Fax |
02532517170 |
| Email |
sonambekar.chinmay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nilam kisan Bahiram |
| Designation |
P G scholar |
| Affiliation |
Ayurved seva sangh,Ayurved mahavidyalaya,nashik |
| Address |
OPD no 6 Shalyatantra OPD
Nashik
MAHARASHTRA
422003
India |
| Phone |
8623946284 |
| Fax |
02532517170 |
| Email |
neelambahiram13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nilam kisan Bahiram
Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik |
|
|
Primary Sponsor
|
| Name |
Ayurved Mahavidyalaya Nashik |
| Address |
Ayurved Seva Sangh Ayurved Mahavidyalaya Ganeshwadi Panchvati Nasik |
| Type of Sponsor |
Other [ State Govt Grant in aid Institute] |
|
|
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 Nilam Kisan Bahiram |
Arogyashala Rugnalaya |
OPD no 6 Shalyatantra OPD
Nashik
MAHARASHTRA |
8623946284
02532517170
neelambahiram13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
shuddha vrana |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
betadine ointment |
ointment will be applied over wound site upto 50 cm2 once in day for 15 days |
| Intervention |
Kakubhadi Ointment |
Ointment applied over the wound site upto 50 cm2 once in day for 15 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
wound size less than 50 sqcm
Patients with shuddha vrana
Patient who will give consent for study
OPD and IPD patients from Shalyatantra department
Both Nija and Agantuj shuddha vrana
Osteomyelitis Tuberculosis Malignant wound diagnosed as shuddha vrana |
|
| ExclusionCriteria |
| Details |
wound size greater than 50 sqcm
Immunocompramised patients like HIV & HBSAG positive
Varicose ulcer
Diabetic wound
vericose ulcer & diabetic foot wound size greater than 50cm2
wound size greater than 50 cm2immunocompramised patients with HIV & HBSAG vericose ulcer & diabetic wounds |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Healing of shuddha wound
Reduction in pain inflammation discharge
by applying ointment swelling pain redness etc get reduced wound will heal fast |
15 days
by applying ointment swelling pain redness etc get reduced wound will heal fast |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| healing of wound occurs at wound site |
15 days |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
10/09/2020 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Kakubhadi ointment is the formulation which contains ashoka pimpal udumbar lodhra jambuphala n katphala churna which shows healing properties within short period of time at wound site.all these drugs are mentiond in vranaropaka gana as per their properties.by applying it on wound site symptomes lika vrana shoth,vrana srav,& vedaa reduces . |