| CTRI Number |
CTRI/2021/08/035340 [Registered on: 02/08/2021] Trial Registered Prospectively |
| Last Modified On: |
24/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Irritation potential of Silever
Shampoo |
|
Scientific Title of Study
|
Evaluation of irritation potential of Silever
Shampoo through dermatological Evaluation
by single occlusive patch test on Healthy
adult human volunteers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Sakthi Balan |
| Designation |
Principal Investigator/Medical Consultant |
| Affiliation |
KI3, CRO |
| Address |
Room no.1, Diabetology OPD Dept., Thirumalai Clinic, C/o. Raghavendra
Diagnostic Centre, 153, Cuddalore main road, Mudaliarpet
Pondicherry
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Sakthi Balan |
| Designation |
Principal Investigator/Medical Consultant |
| Affiliation |
KI3, CRO |
| Address |
Room no.1, Diabetology OPD Dept., Thirumalai Clinic, C/o. Raghavendra
Diagnostic Centre, 153, Cuddalore main road, Mudaliarpet
Pondicherry
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Sakthi Balan |
| Designation |
Principal Investigator/Medical Consultant |
| Affiliation |
KI3, CRO |
| Address |
Room no.1, Diabetology OPD Dept., Thirumalai Clinic, C/o. Raghavendra
Diagnostic Centre, 153, Cuddalore main road, Mudaliarpet
Pondicherry
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
|
Source of Monetary or Material Support
|
| MS Everclean Technologies Pvt. Ltd, A-70, PIPDIC Industrial Estate, Sedarapet, Puducherry 605111 |
|
|
Primary Sponsor
|
| Name |
MS EVERCLEAN TECHNOLOGIES PVT LTD |
| Address |
Plot No:- A-70, PIPDIC INDUSTRIAL ESTATE, SEDARAPET ,
PONDICHERRY- 605 111. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Sakthi Balan |
Thirumalai Clinic and Raghavendra Diagnostic Centre |
Room no.1,
Diabetology OPD,
Thirumalai Clinic, C/o.
Raghavendra
Diagnostic Centre, 153,
Cuddalore main road,
Mudaliarpet,
Pondicherry
Pondicherry
PONDICHERRY |
9443627722
saheerose@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ki3 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Skin Sensitivity Testing |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: 1) Rajata Bhasma (in liquid) 2)Sodium Carboxy Methyl Cellulose 3) Virgin Coconut oil 4) Sodium Lauryl Sarcosinate , Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 1) Rajata Bhasma (in liquid) 2)Sodium Carboxy Methyl Cellulose 3) Virgin Coconut oil 4) Sodium Lauryl Sarcosinate , Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (3) Medicine Name: , Reference: NA, Route: , Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy subjects with healthy skin on the studied anatomic unit (free of eczema, wounds & any other
inflammatory scar)
2. Age group of 18 to 55 years, 12 male and 12 female subjects.
3. Compliance with the study procedures involved. |
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating women
2. Subjects with any other skin disorders.
3. Use of any other topical agents for any skin related conditions (at the site of application of patch)
during the past 30 days. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluation of mean scores of
Erythema/dryness/wrinkles, Oedema and Mean
irritation index
|
Day 1,2,3 and 8
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| occurrence of any adverse effects |
Day 1,2,3 and 8 |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
06/08/2021 |
| Date of Study Completion (India) |
24/08/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
24 adult healthy subjects will be selected for the study. The subjects selected for the study will be healthy females and males, aged between 18 and 55 years old, in which 12 will be females and 12 will be male subjects. The entire study procedure, patch application, patch reading and grading is detailed in the protocol and followed as per the protocol. The patch applied contain Finn’s Chamber within which 2 drops of the test product will be filled in a separate chamber. The patch is applied on the back or shoulder area of the subjects and will be in contact with skin for 24 hours. If the subject experiences any allergic reaction, the patch can be removed within 24 hours and reported to the investigator immediately. The mean score of Erythema/ dryness/ wrinkles. Oedema and Mean Irritation Index will be calculated on day 1,2,3 and 8 |