| CTRI Number |
CTRI/2022/08/044805 [Registered on: 22/08/2022] Trial Registered Prospectively |
| Last Modified On: |
03/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety evaluation of VIP Snore care Oil |
|
Scientific Title of Study
|
“Dermatological safety evaluation of VIP SNORE CARE OIL by Primary Irritation Patch test within 24
hours application on all types of healthy human skin |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TG/CLI/063b, Version 1.0 Dated 11-Jul-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep K Alva |
| 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 |
8867125414 |
| Fax |
|
| Email |
sandyalva78@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep K Alva |
| Designation |
Principal Investigator |
| Affiliation |
Trial Guna Pvt Ltd |
| Address |
467, 1st Main Rd, Royal County, 8th Phase, Gottigere, Bengaluru, Karnataka
KARNATAKA
560083
India |
| Phone |
8867125414 |
| Fax |
|
| Email |
sandyalva78@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 |
9972636265 |
| Fax |
|
| Email |
meena@trialguna.com |
|
|
Source of Monetary or Material Support
|
| Buy happy Marketing LLP
Prince info park, No. 81 B, 2nd floor, Tower B, 2nd Main, Sai
Nagar, Ambattur Industrial estate, Chennai, Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Buy happy Marketing LLP |
| Address |
Buy happy Marketing LLP
Prince info park, No. 81 B, 2nd floor, Tower B, 2nd Main, Sai Nagar, Ambattur Industrial estate, Chennai, Tamil Nadu |
| Type of Sponsor |
Other [Pvt Ltd] |
|
|
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 Sandeep K Alva |
TrialGuna Private Limited |
467, 1st Main Rd, Royal County, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA |
9695047152
sandyalva78@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Ocimum Sanctum extract, Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 4(drops), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 8 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy Men and women volunteers are chosen in ratio of 1:1 aged > 35 and < 60years.10% of
the sample size, are chosen such that who are having a snoring issue while sleeping.
2.Subjects who are willing to participate in the study and sign the informed consent document
and comply with the trial procedure.
3.Having healthy skin on test area as assessed by dermatological examination and don’t have history of allergy.
4.Subjects who are compliant with the study.
|
|
| 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 |
Number of subjects that showed no significant irritation.
Score of less than or equal to 2 on the Draize scale |
Day 0,1,2,3,4,5 |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
23/08/2022 |
| Date of Study Completion (India) |
29/08/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="8" |
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
|
clinical study was initiated for estimation of the overall safety of test products by PIPT within 24 hours of application on healthy skin types. 24 healthy female and male (1:1) subjects of age group 35 to 60 Years have to be recruited. There are test products and one Negative control and Positive control. There are 5 visits and
the total duration of the study is 8 days. Subject’s Self-Assessment on skin irritation (baseline assessment for burning, itching, and stinging).Dermatologist’s Visual assessment as per Draize scale scoring system (for Erythema and Oedema) will be done |