|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
CTRI |
|
Last refreshed on:
|
24 November 2021 |
|
Main ID: |
CTRI/2015/02/005587 |
|
Date of registration:
|
26-02-2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Effect of herbal medicine Vranari Guggulu and Vrana lepa for Diabetic Foot wound
|
|
Scientific title:
|
A Clinical Study of the effect and validation of Vranari Guggulu and Karanjadi Vranalepa in the management of Madhumeha janya vrana (Diabetic Foot Ulcer)
management of Madhumehajanya Vrana (Diabetic Foot Ulcer) |
|
Date of first enrolment:
|
15-09-2014 |
|
Target sample size:
|
100 |
|
Recruitment status: |
Open to Recruitment |
|
URL:
|
http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=10376 |
|
Study type:
|
Interventional |
|
Study design:
|
Randomized, Parallel Group Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Centralized Blinding and masking:Open Label
|
|
Phase:
|
Post Marketing Surveillance
|
|
|
Countries of recruitment
|
|
India
| | | | | | | |
|
Contacts
|
|
Name:
|
Dr K M V D Prasad
|
|
Address:
|
Department of Salya, Dr NRS Govt.Ayurvedic College, Vijayawada
520010
Krishna, ANDHRA PRADESH
India |
|
Telephone:
|
9440457504 |
|
Email:
|
pkundem@yahoo.com |
|
Affiliation:
|
Dr NRS Govt.Ayurvedic College, Vijayawada |
|
|
Name:
|
Dr Chadalawada Venkata Siva Koteswara Rao
|
|
Address:
|
Department of Sareera Rachana, Dr NRS Govt.Ayurvedic College, Vijayawada Dr NRS Govt.Ayurvedic College, Vijayawada
520010
Guntur, ANDHRA PRADESH
India |
|
Telephone:
|
9440457504 |
|
Email:
|
pkundem@yahoo.com |
|
Affiliation:
|
Dr NRS Govt.Ayurvedic College, Vijayawada |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1.Patients of both sexes between the age group of 18-60 yrs.
2.Type I and II DM
3.After hematological examination Clinically Diagnosed confirmed as Diabetic Foot Ulcer
4.Chronic ulcer secondary to Diabetes of 30 days duration
Exclusion criteria: 1.H/o Infectious and systemic diseases
2.Ulcer on heel
3.Ulcer with exposed bone and tendon
4.Patients suffering with Immune deficiency
5.Coagulation disorders
6.Cellulitis
7.Gangrene
8.Presence of underlying Osteomyelitis
9.Pregnant women
10.Malignancies
11. Blood profiling done to exclude other diseases
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
|
Health Condition 1: null- Diabetic Foot Ulcer
|
|
Intervention(s)
|
Intervention1: Vranari Guggulu and Karanjadi
Vranalepa
: Commercially available herbal drug Vranari Guggulu 500 mg twice daily with water internally and
Karanjadi Vranalepa as external
application for 45 days
Control Intervention1: Kanchanara Guggulu and
Vajraka thailam
: Commercially available herbal drug given twice daily with water internally and
Vajraka thailam as external
application for 45 days
|
|
Primary Outcome(s)
|
Relief in signs and symptoms, mean percentage change in wound area and pain.
complete wound closure is defined as skin re-epitheliazation without drainage or dressing requirment.Timepoint: Treatment period 45 days, assessment for every week, active follow up visit on every week for 45 days.
|
|
Secondary Outcome(s)
|
Improve general condition of the patient
wound healing
Timepoint: Treatment period : 45 days
Assessment in every week
Active follow up : 45 days
|
|
Source(s) of Monetary Support
|
|
SELF
|
|
Ethics review
|
Status: Approved
Approval date: 11/09/2014
Contact:
Institutional ethical committe
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|