| CTRI Number |
CTRI/2023/03/050796 [Registered on: 17/03/2023] Trial Registered Prospectively |
| Last Modified On: |
28/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Safety evaluation of test products on healthy skin type |
|
Scientific Title of Study
|
“Dermatological safety evaluation of test products by Primary Irritation Patch Test within 24 hours of apply
on healthy human all skin types |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TG/CLI/069a, Version 1.0Dated 04 Mar 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr B Sohandas Shetty |
| Designation |
Principal Investigator |
| Affiliation |
Trial Guna Pvt Ltd |
| Address |
467, 1st Main Rd, Royal County, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA
560083
India |
| Phone |
|
| Fax |
|
| Email |
drsohanshetty@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Sohandas Shetty |
| Designation |
Principal Investigator |
| Affiliation |
Trial Guna Pvt Ltd |
| Address |
467, 1st Main Rd, Royal County, 8th Phase, Gottigere, Bengaluru, Karnataka
KARNATAKA
560083
India |
| Phone |
|
| Fax |
|
| Email |
drsohanshetty@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Meena Dalal |
| Designation |
CRO Representative |
| Affiliation |
Trial Guna Pvt Ltd |
| Address |
467, 1st Main Rd, Royal County, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA
560083
India |
| Phone |
|
| Fax |
|
| Email |
meena@trialguna.com |
|
|
Source of Monetary or Material Support
|
| Dabur India Limited
Dabur Research & Development Centre
Plot No.22, Site-IV, Shahibabad-201010
Ghaziabad (U.P.), India |
|
|
Primary Sponsor
|
| Name |
Dabur India Limited |
| Address |
Dabur Research & Development Centre
Plot No.22, Site-IV, Shahibabad-201010
Ghaziabad (U.P.), India |
| Type of Sponsor |
Other [consumer goods company] |
|
|
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 Sohandas Shetty |
TrialGuna Private Limited |
467, 2nd floor,1st Main Rd, Royal County, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA |
09972335018
drsohanshetty@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Haelthy Human |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Pain Balm, Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(drops), Frequency: od, Bhaishajya Kal: Muhurmuhu, Duration: 9 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Voluntary men and women ratio of 1:1 between 18 and 65 years.
2.Having healthy skin on test area as assessed by dermatological examination.
3.For whom the investigator considers that the compliance will be correct.
4.Subjects with normal, dry, oily and combination skin
5.Subjects cooperating informed of the need and duration of the examination and ready to comply
with protocol procedures.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant/nursing mothers.
2.Scars, excessive terminal hair, or tattoo on the studied area.
3.Dermatological infection/pathology on level of studied area.
4.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material)
5.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or
procedures |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Number of subjects that showed
2.No significant irritation.
Score of less than or equal to 2 on the Draize scale. |
Day 1, Day 2, Day 3, Day 8 |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
21/03/2023 |
| Date of Study Completion (India) |
06/04/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="9" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Irritants are substances that provoke immediate response in the skin perceived as a superficial skin reaction in terms of erythema, oedema and/or papules. The severity of irritation depends upon the nature, concentration, and duration of exposure. Irritation is manifested as inflammatory responses such as erythema (redness), oedema (swelling), and vesiculation and finally, to an intense supportive reaction without the involvement of the immune system. In this patch test the irritation potential of a substance is assessed by a single application of patch under complete occlusion for 24 hrs |