| CTRI Number |
CTRI/2015/02/005586 [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
|
A clinical study of Vranari Guggulu and Vrana lepa in the management of Diabetic Foot Ulcer |
|
Scientific Title of Study
|
A Clinical Study of the effect and validation of Vranari Guggulu and Karanjadi Vranalepa in the 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. NTR Health University, Andhra Pradesh |
| Address |
Dr. NRS Govt. Ayurvedic College
Vijayawada
Andhra Pradesh
Dr. NRS Govt. Ayurvedic College
Vijayawada
Andhra Pradesh
Krishna
ANDHRA PRADESH
522006
India |
| Phone |
9441072007 |
| Fax |
|
| Email |
ayurdoctor007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chadalawada Venkata Siva Koteswara Rao |
| Designation |
Lecturer |
| Affiliation |
Dr. NTR Health University, Andhra Pradesh |
| Address |
Dr. NRS Govt. Ayurvedic College
Vijayawada
Andhra Pradesh
Dr. NRS Govt. Ayurvedic College
Vijayawada
Andhra Pradesh
Krishna
ANDHRA PRADESH
522006
India |
| Phone |
9441072007 |
| Fax |
|
| Email |
ayurdoctor007@gmail.com |
|
Details of Contact Person
Public Query
|
| 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
MG Road,Vijayawada
Krishna
ANDHRA PRADESH
520002
India |
| Phone |
9441072007 |
| Fax |
|
| Email |
ayurdoctor007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr NRS Govt Ayurvedic College |
|
|
Primary Sponsor
|
| Name |
DrNRS GovtAyurvedic College |
| Address |
MG Road, Vijayawada |
| Type of Sponsor |
Government medical college |
|
|
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 Ch V S Koteswara Rao |
Division of Shalya |
Dr. NRS Govt. Ayurvedic College
Dr. NTR Health University
M.G. Raod
Vijayawada
Krishna
ANDHRA PRADESH |
9441072007
ayurdoctor007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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 |
Kanchanara Guggulu 500 mg bid with water internally and Vajraka thailam as external application for 45 days |
| Intervention |
Vranari Guggulu and
Karanjadi Vranalepa |
Vranari Guggulu 500 mg bid 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.Clinically Diagnosed as Diabetic Foot Ulcer
4.Target ulcer duration more than 30 days |
|
| ExclusionCriteria |
| Details |
1.H/o Infectious and systemic diseases
2.Ulcer on heel
3.Ulcer with exposed bone and tendon
4.Immune deficiency
5.Coagulation disorders
6.Cellulitis
7.Gangrene
8.Presence of underlying Osteomyelitis
9.Pregnant women
10.Malignancies |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean percentage change in wound area,pain
Recognized clinical prognostic factors like reduction in wound area and depth and wound healing
Proportion of patients with complete wound closure |
Treatment period : 45 days
Assessment in every week
Active follow up : 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
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/11/2014 |
| 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
|
A clinical trial is initiated to generate evidence for the scientific validation of the clinical efficacy and safety of classical Ayurvedic formulation Vranari Guggulu twp tablets(500mg) and Karanjadi Vranalepa(external application) in Madhumehajanya Vrana (Diabetic Foot Ulcer) at Dr.NRS Govt. Ayurvedic College, Vijayawada for the PhD study under Dr.NTR University of Health Sciences, Vijayawada. In the study Vranari Guggulu 500 mg b.i.d. internal administration and Karanjadi Vrana lepa as external application given for Group I patients (i.e. 50 patients), Kanchanara Guggulu 500 mg b.i.d. internal administration and Vajraka thailam as external application given for Group II patients (another 50 patients). This study will be conducted in India and completed in 4 years duration. 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. Any adverse drug reaction or event occurs during the trial also will be documented.
Kanchanara Guggulu consists of bauhinia varigata, terminalia chebula, terminalia bellerica, emblica officinalis, zingiber officinale, piper nigrum, piper longum, crataeva nurvala, elettaria cardamomum, cinnamomum zeylanicum, commiphora mukul.
Vajraka thailam consists of saptaparna, karanja, malathi, chitraka, sariva, vatsaka, langali and gomutra and thailam.
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.
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