CTRI/2017/09/009703 [Registered on: 11/09/2017] Trial Registered Retrospectively
Last Modified On:
09/06/2020
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Clinical study on Topical Herbal Sprays on Ulcers
Scientific Title of Study
A Randomized, Open Labeled, Multi-center, Prospective, Comparative Clinical Study to evaluate efficacy and safety of Topical Herbal Sprays on Non Healing Ulcers – Diabetic Foot Ulcers & Varicose Ulcers
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
DFU-VU/THS/MHCL/2017,Version 1.0,18 Feb 2017
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Kamalakar Gajre
Designation
Associate Professor
Affiliation
AMs SS Ayurveda Mahavidyalaya and Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Address
Department of Shalya Tantra
OPD No 3 Ground Floor MAMs SS Ayurveda Mahavidyalaya and Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune MAHARASHTRA 411028 India
Phone
9850123482
Fax
Email
drgajarekv@gmail.com
Details of Contact Person Scientific Query
Name
Dr Sanjay Tamoli
Designation
Director
Affiliation
Target Institute of Medical Education and Research
Address
Target Institute of Medical Education and Research, Ground Floor, Shop No 2. 205 B Wing Blue Diamond Society Nayagoan Dahisar West Mumbai
Mumbai (Suburban) MAHARASHTRA 400068 India
Phone
9322522252
Fax
09322522252
Email
targetinstitute@yahoo.com
Details of Contact Person Public Query
Name
Vandana Bade
Designation
Manager - Clinical Trial Operation
Affiliation
Target Institute of Medical Education and Research
Address
Target Institute of Medical Education and Research, Ground Floor, Shop No 2. 205 B Wing Blue Diamond Society Nayagoan Dahisar West Mumbai
Mumbai (Suburban) MAHARASHTRA 400068 India
Phone
8149507065
Fax
8149507065
Email
vandana@targetinstitute.in
Source of Monetary or Material Support
Millennium Herbal Care Ltd
12 B Nirmal, 241/242 ,
Backbay Reclamation,
Nariman Point,
Mumbai 400 021
Primary Sponsor
Name
Millennium Herbal Care Ltd
Address
12 B Nirmal, 241/242 ,
Backbay Reclamation,
Nariman Point,
Mumbai 400 021
Ayurved Seva Sangh, Ayurved Sanshodhan Vibhag, Ganeshwadi, Panchvati, Nasik
Department of shalytantra, opd no 6, Aarogyashala rugnalay, Ayurved Seva Sangh, Ganeshvadi, Panchavati, Nashik Nashik MAHARASHTRA
9405369727
drsantoshsp@gmail.com
Dr Quadri Mehfuzulla Jeelani
Government Ayurvedic College Solapur Road Madhuban Osmanabad
Department of Shalya Tantra
2nd Floor Room No 54 Government Ayurvedic College Solapur Road Madhuban Osmanabad 413501
Osmanabad MAHARASHTRA
9226959389
drquadrimj@gmail.com
Dr Vijay P Ukhalkar
Govt. Ayurved College Vazirabad, Nanded
Department of Shalya Tantra Ground Floor Room No. 4 Govt. Ayurved College Vazirabad Nanded 431601
Nanded MAHARASHTRA
9422171987
ukhalkarvp@gmail.com
Dr Kamalakar Gajre
MAMs SS Ayurveda Mahavidyalaya and Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Department of Shalya Tantra
OPD No 3 Ground Floor MAMs SS Ayurveda Mahavidyalaya and Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 411028 Pune MAHARASHTRA
9850123482 9850123482 drgajarekv@gmail.com
Dr Yunus G Solanki
R A Podar Medical College(Ayu) M.A.Podar Hospital Worli, Mumbai
Associate Professor Department of Shalya Tantra
OPD No.4 1st Floor R A Podar Medical College(Ayu)
M.A.Podar Hospital Worli,
Mumbai 400018
Mumbai MAHARASHTRA
9869073838
dryunussolanki@rediffmail.com
Dr G Shrinivasa Acharya
S.D.M. College of Ayurveda, Kuthpady,Udupi
P.G.Department of Kayachikitsa and Manasaroga, Ground Floor OPD No. 7 S.D.M. College of Ayurveda, Kuthpady Udupi Karnataka 574 118 Udupi KARNATAKA
Hydrogen peroxide for cleaning purpose and then application of Povidone iodine 10% followed by dressing of the ulcer daily for 3 months or till complete healing of ulcer whichever is earlier
Millennium Panchvalkal Kwath Spray (PKS) for cleaning purpose and then by application of Healz Spray (JTS) followed by dressing of the ulcer daily for 3 months or till complete healing of ulcer whichever is earlier
Inclusion Criteria
Age From
18.00 Year(s)
Age To
70.00 Year(s)
Gender
Both
Details
1. Patients having either Type I or Type II Diabetes with non-healing Diabetic Foot Ulcers or patients having non-healing Varicose Ulcers with or without Diabetes
2. Diabetic patients having HbA1C < 8.
3. Patients having either Diabetic Foot Ulcer or Varicose Ulcers with the following Ulcer characteristics :
a. Neuropathic and mild Neuro-ischaemic
Diabetic Foot Ulcer (Single or multiple ulcers)
b. Diabetic Foot ulcers with Grade 1 to 2
(Wagener’s classification)(Appendix B)
c. Non-Healing Varicose Ulcers
d. Duration of ulcer more than 1 month
e. Surface area of the Non-Healing Ulcer
between 1 cm2 to 25 cm2
5. Patients willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
ExclusionCriteria
Details
1) Patients with ischemic Ulcers (Diagnosed Clinically and/or with Doppler)
2. Known cases of Severe/Chronic Hepatic or Renal disease.
3. Known cases of any active malignancy.
4. Patients giving history of significant cardiovascular event < 12 weeks prior to randomization.
5) Chronic alcoholics / Alcohol Abuse.
6) Patients ECG demonstrating any signs of uncontrolled arrhythmia / acute ischemia.
7) Patients X- ray chest showing any active lesion of tuberculosis.
8) Patients having known chronic, contagious infectious disease, such as active tuberculosis Hepatitis B or C, or HIV.
9)Patients using any other investigational drug within 1 month prior to recruitment.
10) Known hypersensitivity to any of the ingredients used in study drug.
11) Pregnant and Lactating females.
12) Patients currently participating in any other Clinical study or any education treatment program for Ulcers.
13) Patients having any other medical or surgical condition considered unsuitable for his/her participation in the study as per Investigator’s judgment.
14) Patients receiving drugs which may interact with the study therapeutic protocol such as glucocorticoids, immunosuppressive and cytotoxic drugs.
15) Patients who have undergone ulcer treatments with cell therapy, dermal substitutes, or other biological therapies within the last 30 days.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Assessment of change in ulcerated area (weekly till either complete ulcer healing or 3 months, whichever is ealrlier).
Day -5, Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Visit Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 84, Day 91
Secondary Outcome
Outcome
TimePoints
1)Assessment of changes in ulcer
2)Assessment of changes in ulcer by Digital Photographs 3) Assessment of time required for complete healing
4)Assessment of requirement of Antibiotics, anti-inflammatory drugs
5)Assessment of adverse event by clinical evaluation, AE/SAE recording, Vitals and Lab Parameters
6)Assessment of clinical global evaluation for overall efficacy by physician and by the patient
7)Assessment of overall acceptability/tolerability by Subject and physician
Day -5, Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Visit Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 84, Day 91.
Target Sample Size
Total Sample Size="72" Sample Size from India="72" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
It is A Randomized, Open Labeled, Multi-center, Prospective, Comparative
Clinical Study to evaluate efficacy and safety of Topical Herbal Sprays on Non
Healing Ulcers – Diabetic Foot Ulcers & Varicose Ulcers. The trial will be
completed in 72 patients in 4 centers across India. Subjects from group A will
be advised to clean their ulcer using Millennium Panchvalkal Kwath Spray (PKS) and
then by application of Healz Spray (JTS) followed by dressing of the ulcer for
3 months of complete healing of ulcer whichever is earlier. Subjects from group B will be advised to clean
their ulcer using Hydrogen peroxide and/or Hypochlorite Solution and then application
of Povidone iodine 10% (Betadine) followed by dressing of the ulcer for 3
months of complete healing of ulcer whichever is earlier. The primary objective of the study is
to evaluate change in ulcerated area on Day -5, Day 0, Day 7, Day 14, Day 21, Day
28, Day 35, Visit Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 84, Day
91. The secondary objectives are to evaluate changes in ulcer by Clinical
Examination, changes in ulcer by Digital Photographs, time required for
complete healing (if ulcer heals completely, requirement of Antibiotics,
anti-inflammatory drugs, adverse event by clinical evaluation, AE/SAE
recording, Vitals and Lab Parameters, clinical global evaluation for overall
efficacy by physician and by the patient and overall acceptability/tolerability
by Subject and physician on Day -5, Day 0, Day 7, Day 14, Day 21, Day 28, Day
35, Visit Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 84, Day 91.