| CTRI Number |
CTRI/2020/11/029257 [Registered on: 20/11/2020] Trial Registered Prospectively |
| Last Modified On: |
19/11/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Testing of a herbal antiseptic for wound infections |
|
Scientific Title of Study
|
Evaluation of a novel herbal antiseptic formulation – SEPIL for the treatment of chronic limb ulcers and pressure ulcers: A randomized, Double-blind, Placebo-Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijay Sharma |
| Designation |
Consultant |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) |
| Address |
Professor
Department of Orthopedics
JPNA Trauma Centre
AIIMS Raj nagar, New Delhi-29
Department of Orthopedics
JPNA Trauma Centre
AIIMS Raj nagar, New Delhi-29
New Delhi
DELHI
110029
India |
| Phone |
9868397122 |
| Fax |
|
| Email |
drvijaysharmatrauma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Sharma |
| Designation |
Consultant |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) |
| Address |
Professor
Department of Orthopedics
JPNA Trauma Centre
AIIMS Raj nagar, New Delhi-29
Department of Orthopedics
JPNA Trauma Centre
AIIMS Raj nagar, New Delhi-29
New Delhi
DELHI
110029
India |
| Phone |
9868397122 |
| Fax |
|
| Email |
drvijaysharmatrauma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Sharma |
| Designation |
Consultant |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) |
| Address |
Professor
Department of Orthopedics
JPNA Trauma Centre
AIIMS Raj nagar, New Delhi-29
Department of Orthopedics
JPNA Trauma Centre
AIIMS Raj nagar, New Delhi-29
DELHI
110029
India |
| Phone |
9868397122 |
| Fax |
|
| Email |
drvijaysharmatrauma@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Vikas Gautam |
| Address |
Department of Medical Microbiology PGIMER, Sector-12 Chandigarh |
| Type of Sponsor |
Other [Self] |
|
|
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 Vijay Sharma |
All India Institute of Medical Sciences (AIIMS), New Delhi |
Room No. 407, 4th Floor, Main Block
Department of Orthopedics
JPNA Trauma Centre
AIIMS Raj nagar, New Delhi-29
New Delhi
DELHI |
9868397122
drvijaysharmatrauma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Povidone Iodine |
Povidone iodine is the topical antiseptic that is being used and new intervention (Sepil - polyherbal formulation) will be compared to this.
Dose: 1-2 ml
Frequency: once a day
Route of administration: Topical application
Duration: up to 28 days |
| Intervention |
Sepil - A herbal antiseptic (Topical Application) |
Sepil (polyherbal formulation) is a synergistic composition of a herbal oil (OHA) and a plant extract (OHB) that has drastically enhanced efficacy as compared to the ingredients alone.
Dose: 1-2 ml
Frequency: once/twice a day Route of administration: Topical application
Duration: up to 28 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult men and women aged 18 years or older
2. A diagnosis of diabetic ulcer or limb ulcer (arterial or venous ulcer) or decubitus (pressure) ulcer; and
3. Wound size <10 cm in diameter (preferably).
|
|
| ExclusionCriteria |
| Details |
1. Infection to be cured with antibiotics
2. Deep ulcer reaching bone tissue
3. Severe edema around skin ulcer,
4. Patients with severe heart failure, severe liver, kidney, and blood dysfunction,
5. Poor general condition due to severe systemic infection,
6. Poor control of hyperglycemia (HbA1c ≧9.0%)
7. Pregnant women, and men or women who disagree to avoid pregnancy during clinical trial period
8. Surgical procedure for skin ulcer from 2 weeks before SEPIL or placebo treatment,
9. Participation in other clinical trial from 12 weeks before entry,
10. Judgment as an inappropriate patient by principle investigator. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome measure will be the rate of wound size reduction at 4 weeks after the first treatment compared with pre-treatment wound size. |
The safety of SEPIL topical treatment will be evaluated during the treatment period (28 days) every 7 days and post-treatment (30 days) according to the Common Terminology Criteria for Adverse Events (version 5.0). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Additionally, the following secondary endpoints will be measured at 4 weeks after the first treatment and compared with pre-treatment status: time to wound closure; 50% wound size reduction ratio; quantification of Gram-negatives - Pseudomonas aeruginosa, Acinetobacter, Klebsiella, Escherichia coli and others; Gram-positives - Staphylococcus aureus (including methicillin resistant S. aureus, MRSA), Streptococcus pyogenes; and overall evaluated ulcer improvement. |
Secondary endpoints will be measured at 4 weeks after the first treatment and compared with pre-treatment status |
|
|
Target Sample Size
|
Total Sample Size="168"
Sample Size from India="168"
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
|
N/A |
|
Date of First Enrollment (India)
|
23/11/2020 |
| 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="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Purpose of Trial: To examine the safety and efficacy of polyherbal formulation (Sepil). The antibiotic pipeline has been dry for several years with no new compound to combat menace caused by multi-drug resistant bacteria in particular colistin-resistant bacteria. We have developed a highly potent synergistic composition of a herbal oil (OHA) and a plant extract (OHB) that has drastically enhanced efficacy as compared to the ingredients alone. It’s available in oil form and has been shown to be effective in vitro as well as in experiment models of wound infections in mice. This herbal combination has been developed, patent in is in the Order of Grant, and recognized as Novel with industrial applicability by the International Search Report under PCT. Patients developing non-healing wounds form a heterogeneous group, and non-healing wounds are commonly divided into pressure ulcers, venous leg ulcers, arterial ulcers, and diabetic foot ulcers (DFUs). Non-healing wounds do not only cause discomfort, pain, and increased risk for amputation, but are also associated with substantial health-care costs. The current lack of efficient treatments for non-healing wounds is dependent on several factors. Our indigenously prepared formulation can prove to be effective therapy for such patients and improve their outcomes. Given the promising results obtained in preclinical studies, we propose to test its efficacy and safety in healthy volunteers as well as patients. (1) STUDY OBJECTIVES PRIMARY OBJECTIVES 1. To examine the safety of topically applied novel herbal antiseptic, SEPIL as a first in human study for cutaneous ulcers. 2. To evaluate the efficacy and safety of SEPIL as compared to placebo for 4 weeks in patients diagnosed with chronic limb ulcers. SECONDARY OBJECTIVES 1. To assess the impact of topical treatment with SEPIL on patients’ quality of life using Cardiff Wound Impact Schedule (CWIS) tool and Hyland questionnaire. 2. To assess impact on ulcer related pain using short form McGill pain questionnaire. 3. To evaluate the efficacy of SEPIL to prevent the formation or disrupting existing biofilms. Findings: Recruitment not yet started Publications: Nil IPR values: Patent is in Order of Grant for this herbal formulation u/s 43 of the of The Patents Act, 1970 in Feb 2020for its anti-bacterial activity. Applicant: Dr Vikas Gautam, Professor, Dept of Medical Microbiology, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh. |