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Main
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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. |
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Register:
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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2015/02/005586 |
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Date of registration:
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26-02-2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A clinical study of Vranari Guggulu and Vrana lepa in the management of Diabetic Foot Ulcer
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Scientific title:
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A Clinical Study of the effect and validation of Vranari Guggulu and Karanjadi Vranalepa in the management of Madhumehajanya Vrana (Diabetic Foot Ulcer) |
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Date of first enrolment:
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25-11-2014 |
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Target sample size:
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100 |
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Recruitment status: |
Open to Recruitment |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=10191 |
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Study type:
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Interventional |
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Study design:
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Randomized, Parallel Group Trial
Method of generating randomization sequence:Random Number Table Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label
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Phase:
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Phase 2
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Countries of recruitment
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India
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Contacts
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Name:
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Dr Chadalawada Venkata Siva Koteswara Rao
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Address:
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Dept. of Sareera Rachana
Dr NRS Govt.Ayurvedic College
MG Road, Vijayawada MG Road,Vijayawada
522006
Krishna, ANDHRA PRADESH
India |
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Telephone:
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9441072007 |
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Email:
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ayurdoctor007@gmail.com |
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Affiliation:
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Dr. NTR Health University, Andhra Pradesh |
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Name:
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Dr Chadalawada Venkata Siva Koteswara Rao
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Address:
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Dr. NRS Govt. Ayurvedic College
Vijayawada
Andhra Pradesh Dr. NRS Govt. Ayurvedic College
Vijayawada
Andhra Pradesh
522006
Krishna, ANDHRA PRADESH
India |
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Telephone:
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9441072007 |
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Email:
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ayurdoctor007@gmail.com |
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Affiliation:
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Dr. NTR Health University, Andhra Pradesh |
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Key inclusion & exclusion criteria
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Inclusion criteria: 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
Exclusion criteria: 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
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- Diabetic Foot Ulcer
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Intervention(s)
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Intervention1: Vranari Guggulu and
Karanjadi Vranalepa: Vranari Guggulu 500 mg bid with water internally and Karanjadi Vranalepa as external application for 45 days
Control Intervention1: Kanchanara Guggulu and Vajraka thailam: Kanchanara Guggulu 500 mg bid with water internally and Vajraka thailam as external application for 45 days
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Primary Outcome(s)
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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 closureTimepoint: Treatment period : 45 days
Assessment in every week
Active follow up : 45 days
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Secondary Outcome(s)
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Improve general condition of the patient
wound healingTimepoint: Treatment period : 45 days
Assessment in every week
Active follow up : 45 days
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Source(s) of Monetary Support
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Dr NRS Govt Ayurvedic College
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Ethics review
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Status: Approved
Approval date: 11/09/2014
Contact:
Institutional Ethical Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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