| CTRI Number |
CTRI/2015/02/005587 [Registered on: 26/02/2015] Trial Registered Retrospectively |
| Last Modified On: |
21/02/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of herbal medicine Vranari Guggulu and Vrana lepa for Diabetic Foot wound |
|
Scientific Title of Study
|
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) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chadalawada Venkata Siva Koteswara Rao |
| Designation |
Lecturer |
| Affiliation |
Dr NRS Govt.Ayurvedic College, Vijayawada |
| Address |
Dept. of Sareera Rachana
Dr NRS Govt.Ayurvedic College
MG Road, Vijayawada
Dept. of Sareera Rachana
Dr NRS Govt.Ayurvedic College
MG Road, Vijayawada
Krishna
ANDHRA PRADESH
520002
India |
| Phone |
9441072007 |
| Fax |
|
| Email |
ayurdoctor007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K M V D Prasad |
| Designation |
Principal and HOD |
| Affiliation |
Dr NRS Govt.Ayurvedic College, Vijayawada |
| Address |
Department of Salya, Dr NRS Govt.Ayurvedic College, Vijayawada
Krishna
ANDHRA PRADESH
520010
India |
| Phone |
9440457504 |
| Fax |
|
| Email |
pkundem@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chadalawada Venkata Siva Koteswara Rao |
| Designation |
Lecturer |
| Affiliation |
Dr NRS Govt.Ayurvedic College, Vijayawada |
| Address |
Department of Sareera Rachana, Dr NRS Govt.Ayurvedic College, Vijayawada
Dr NRS Govt.Ayurvedic College, Vijayawada
Guntur
ANDHRA PRADESH
522006
India |
| Phone |
|
| Fax |
|
| Email |
ayurdoctor007@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Chadalawada Venkata Siva Koteswara Rao |
| Address |
Sareera Rachana Department, Dr NRS Govt.Ayurvedic College, Vijayawada |
| Type of Sponsor |
Other [] |
|
|
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 Chadalawada Venkata Siva Koteswara Rao |
DEPARTMENT OF SALYA |
Dr NRS Govt.Ayurvedic College, Vijayawada
Krishna
ANDHRA PRADESH |
9441072007
ayurdoctor007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Diabetic Foot Ulcer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Kanchanara Guggulu and
Vajraka thailam
|
Commercially available herbal drug given twice daily with water internally and
Vajraka thailam as external
application for 45 days |
| Intervention |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
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. |
Treatment period 45 days, assessment for every week, active follow up visit on every week for 45 days.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improve general condition of the patient
wound healing
|
Treatment period : 45 days
Assessment in every week
Active follow up : 45 days
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/09/2014 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Will be published after completion of the study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study used to check scientific validation of the clinical efficacy and safety of classical Ayurvedic formulation Vranari Guggulu and Karanjadi Vranalepa in Madhumehajanya Vrana (Diabetic Foot Ulcer) aIn the study Vranari Guggulu 500 mg twice daily internal administration and Karanjadi Vrana lepa as external application given for Group I patients (i.e. 50 patients), Kanchanara Guggulu 500 mg twice daily internal administration and Vajraka thailam as external application given for Group II patients (another 50 patients). The primary outcome measures will be relief in signs and symptoms, Mean percentage change in wound area, Recognized clinical prognostic factors like reduction in wound area, depth and wound healing. Proportion of patients with complete wound closure (i.e. complete skin epithelialization) after initiation of study treatment.
Vranari Guggulu consists of pippali(piper logum) 1
part, guggulu(commiphora mukul)5parts, triphala each 3 parts, rasa
sindura 1 part.
Karanjadi vrana lepa consists of sasi(camphor) 1
part, Girivara 2 parts, Tutha(CuSo4) 3 parts, yashti(glycerrhiza) 4
parts, bakuchi(psoralia) 5 parts Karanja 6 parts.
|