| CTRI Number |
CTRI/2021/08/035740 [Registered on: 17/08/2021] 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 Meela Hair care Herbal Oil |
|
Scientific Title of Study
|
Evaluation of irritation potential of
Meela Hair care Herbal Oil 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, Thirumalai Clinic, C/o. Raghavendra Diagnostic Centre, 153, Cuddalore main road, Mudaliarpet Pondicherry
Pondicherry
PONDICHERRY
605004
India
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, Thirumalai Clinic, C/o. Raghavendra Diagnostic Centre, 153, Cuddalore main road, Mudaliarpet Pondicherry
Pondicherry
PONDICHERRY
605004
India
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, Thirumalai Clinic, C/o. Raghavendra Diagnostic Centre, 153, Cuddalore main road, Mudaliarpet Pondicherry
Pondicherry
PONDICHERRY
605004
India
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
|
Source of Monetary or Material Support
|
| Herbland Cosmetics and Manufacturers.,
Puducherry. |
|
|
Primary Sponsor
|
| Name |
Herbland Cosmetics and Manufacturers |
| Address |
Pondicherry |
| 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 Centr |
Room no.1, Diabetology OPD, Thirumalai Clinic, C/o. Raghavendra Diagnostic Centre, 153, Cuddalore main road, Mudaliarpet, Pondicherry
Pondicherry
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) Coconut oil 2) Castor oil 3)Aloe Vera 4)Curry leaves 5)Henna 6) Neela Amari 7) Gooseberry 8) Brahmi 9) Chembarathi 10)Tulsi leaves, 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) Coconut oil 2) Castor oil 3)Aloe Vera 4)Curry leaves 5)Henna 6) Neela Amari 7) Gooseberry 8) Brahmi 9) Chembarathi 10)Tulsi leaves, 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 |
Exclusion criteria:
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
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)
|
22/08/2021 |
| 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 this study will be healthy females and males, aged between 18 and 55 years old. in which 12 will be female 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 protocol. The patch applied to contain Finn’s chamber within which 2 drops of the test product will be filled in separate’s chambers.The patch is applied on the back or shoulder area of the subjects and will be in contact with the skin for 24 hours. If the subject experiences any allergic reactions, the patch can be removed within 24 hours and reported to Investigator immediately. The mean scores of erythema/dryness, wrinkles, oedema mean irritation index will be calculated on day 1,2,3 and 8. |