| CTRI Number |
CTRI/2022/09/045569 [Registered on: 15/09/2022] Trial Registered Prospectively |
| Last Modified On: |
10/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To check efficacy of wundschutzgel in sunburn |
|
Scientific Title of Study
|
An Open Label, Single Arm Clinical Study to Evaluate the healing activity of Wundschutzgel in Sunburn as example of light burns |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NUTRIN011 version 1.0 dated 8 June 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mansoor Riyaz |
| Designation |
Principal Investigator |
| Affiliation |
Shree Ram Hospital |
| Address |
Dept of Dermatology, Room 10, Ground Floor, Shreeram Hospital, NH-58,Partapur,Bye-Pass,Meerut.
Meerut
UTTAR PRADESH
250103
India |
| Phone |
|
| Fax |
|
| Email |
dr.mansoor.naqvi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
Mittal Global Clinical Trial Services |
| Address |
Dept of Clinical Research, First Floor, MGCTS Building, Mansarovar Ind Estate,Panchli Khurd, Uttar Pradesh.
Meerut
UTTAR PRADESH
250005
India |
| Phone |
|
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
Mittal Global Clinical Trial Services |
| Address |
Dept of Clinical Research, First Floor, MGCTS Building, Mansarovar Ind Estate,Panchli Khurd, Uttar Pradesh.
Meerut
UTTAR PRADESH
250005
India |
| Phone |
|
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| Nutrin GmbH, Schnaid 36B, 91352 Hallerndorf, Germany |
|
|
Primary Sponsor
|
| Name |
NUTRIN GmbH |
| Address |
Schnaid 36B, 91352 Hallerndorf, Germany. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Mittal Global Clinical Trial Services |
C-10/3, Street 4, Jwala Nagar, T. P. Nagar, Meerut |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nidhi Dixit |
Shree Ram Hospital |
Dept of General Medicine, Room 8, Ground Floor, Shreeram Hospital, NH-58,Partapur,Bye-Pass,Meerut.
Meerut
UTTAR PRADESH |
7906672912
nidhi21dixit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRAMCH Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T231||Burn of first degree of wrist andhand, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Wundschutzgel gel |
Dose: approx 1ml twice a day route of administration: Topical
duration: 5 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age from 18 to 65 years
2.If female with childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study.
3.Subjects that are able to give written informed consent in a manner approved by the institutional ethics committee and comply with the requirements of the study.
4.Subjects willing to avoid participation in any other interventional clinical trial for the duration of the study.
|
|
| ExclusionCriteria |
| Details |
1.Females that are pregnant, breast feeding, or planning to get pregnant during the study.
2.Patients that have participated in any other interventional clinical trial in the previous 30 days.
3.Patients with known sensitivity to any of the constituents of the investigational product.
4.Any person suffering from heavily bleeding or weeping wound.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Sunburn measured as change in VAS Score |
Baseline (day 0) and Day 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in skin Erythema |
Baseline (day 0) and Day 5 |
| Change in skin Elasticity |
Baseline (day 0) and Day 5 |
| QOL changes to be measured as DLQI |
Baseline (day 0) and Day 5 |
|
|
Target Sample Size
|
Total Sample Size="59"
Sample Size from India="59"
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)
|
15/09/2022 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sunburn is a radiation burn to the skin caused by too much exposure to the sun’s ultraviolet (UV) rays or artificial sources such as tanning beds. The biggest risk factors for sunburn is the amount of time the skin is exposed to UV rays, plus the intensity. Many factors such as time of day, medications, ozone depletion, high altitude, clear skies, and skin phototypes influence sunburns. An increase in the number of sunburns someone obtains is directly related to an increase in the risk of skin cancer. Therefore, by fully understanding the cause, treatment, and prevention of sunburns, patients can drastically decrease their risk of skin cancers. This will improve their quality of life. Additionally, by preventing sunburn, patients can reduce the solar effects of aging, which can lead to better cosmetic results. The assessment will be done on day 0 and day 5 for the change in VAS score, Erythema, and elasticity, and DLQI assessment. |