CTRI Number |
CTRI/2020/08/027425 [Registered on: 27/08/2020] Trial Registered Prospectively |
Last Modified On: |
26/08/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Medical Device Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Ksharaplota treatment in Dushtavrana |
Scientific Title of Study
|
Study the Efficacy of Kshraplota in Dushta Vrana W.S.R.to infected wound |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Anantkumar Shekokar |
Designation |
Professor |
Affiliation |
Shri Vivekananda Nursing Home Trust Ayurveda college |
Address |
Depertment of Shalya Tantra Shri Vivekananda Nursing Home Trust Ayurveda college Rahuri NIL Nanded MAHARASHTRA 413706 India |
Phone |
986076534 |
Fax |
|
Email |
dranantkumarshekokar@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Anantkumar shekokar |
Designation |
Professor |
Affiliation |
Shri Vivekananda Nursing Home Trust Ayurveda college |
Address |
Department of Shalya Tantra Shri Vivekananda Nursing Home Trust Ayurveda college Rahuri NIL Ahmadnagar MAHARASHTRA 413706 India |
Phone |
986076534 |
Fax |
|
Email |
dranantkumarshekokar@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Anantkumar shekokar |
Designation |
Professor |
Affiliation |
Shri Vivekananda Nursing Home Trust Ayurveda college |
Address |
Shri Vivekananda Nursing Home Trust Ayurveda college Rahuri
Ahmadnagar MAHARASHTRA 413706 India |
Phone |
986076534 |
Fax |
|
Email |
dranantkumarshekokar@gmail.com |
|
Source of Monetary or Material Support
|
Government Ayurveda College Nanded 431601 |
|
Primary Sponsor
|
Name |
Dr Anantkumar V Shekokar |
Address |
Shri Vivekananda Nursing Home Trust Ayurveda college Rahuri |
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 Anantumar Shekokar |
Government Ayurved College |
Department of Shalya Tantra Nanded MAHARASHTRA |
986076534
dranantkumarshekokar@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Shri Vivekananda Nursing Home Trust Ayurveda college Rahuri |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
, (1) ICD-10 Condition: T07||Unspecified multiple injuries, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Application of Ksharaplota |
In this group patient of infected wound will be washed with Normal
Saline followed by local application of Ksharaplota once in a day and properly
bandaged with sterile dressing On the next day Ksharaplota will change and in this way it will continue upto appearance of ShudhdavranaLakshanas sign of healing wound or upto 14 days whichever will earlier
|
Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
Inclusion Criteria
|
Age From |
16.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
in the present study dushtavrana patients will be selected from the opd /Ipd of department of shalyatantra having sign of dushtavrana upto 6 cm length and breath 6 cm over extrimities. |
|
ExclusionCriteria |
Details |
Hb% lessthan 10 gm%.Malnourish patient (as per age ,height and weightproportion.Bleeding disorder.diabetes .AIDS,Tuberculosis,Hepatitis,Malaginancy, vericose ulcer.DVT. |
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Efficacy of Ksharaplota in Dushtavrana (infected wound) |
Efficacy of Ksharaplota in Dushtavrana (infected wound) in 4 years |
|
Secondary Outcome
|
Outcome |
TimePoints |
Chedana,Bhedana,Lekhana,shodhana,Ropana and wound healing properties of ksharaplota in Dushtavrana(Infected wound ) |
4 years |
|
Target Sample Size
|
Total Sample Size="435" Sample Size from India="435"
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)
|
30/08/2020 |
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="3" Months="11" Days="20" |
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)?
|
Brief Summary
|
Vrana
( wound and ulcer) & process of healing
is the soul of Shalyatantra Chikitsa (Surgical treatment ) . Dushta Vrana means getting vitiated by
Dosha & hence Dushta Vrana or infected wound is characterized by
bad smell, abnormal color with profuse discharge, severe pain and longer
healing time . The severity of infected wounds and their vast
range of etiologies, The treatment is cleaning & dressing the wound or it can
be more extensive. It may require surgical intervention to close
the wound and stabilize the patient. Acharya
Sushruta defines Kshara as the substance possessing Ksharana
and Kshanan properties.
Ksharaplota
formulation was selected and applied over the affected infected wound with the
help of gauze piece. During the preparation of Ksharaplota, it is coated
with Snuhi kshira, Apamarga kshara & Haridra. All these drugs are
Shodhana & Ropana .
It was observed that Ksharaplota
has the properties as sustained release of drug, absorbs discharges, less
painful & easily acceptable by the patient with excellent Sodhana &
Ropana Karma. The clinical study has been done on 438 patients,
selected randomly and divided in two groups. Group A 220 patients i.e. trial group ,were treated with local
application of Ksharaplota . The Group B 218 patients i.e. control group, were
treated with Gold standard . The clinical assessment was done on the basis of
clinical presentation of Dushta Vrana,(Infected
wound) before and after the treatment.
As
grading used for assessment of parameters which were ordinal in nature,
“Wilcoxon Signed Ranks test†was used for within the group assessment (i.e.
before and after treatment of a group). For between the group assessment of
parameters, Mann Whitney – U test was applied. We had tested hypothesis for each parameter and
result was interpreted accordingly. The level of significance was kept at 5%
(P=0.05). And
the result of the present study found
significant . |