| CTRI Number |
CTRI/2022/09/045339 [Registered on: 08/09/2022] Trial Registered Prospectively |
| Last Modified On: |
28/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To test the irritation potential of Amrutanjan Pain balm |
|
Scientific Title of Study
|
EVALUATION OF IRRITATION POTENTIAL OF PAIN BALMS (A & B) FROM AMRUTANJAN
R&D DEPT. 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 |
SAKTHIBALAN M |
| Designation |
Consultant Physician |
| Affiliation |
Ki3 |
| Address |
Room no.1, Medicine OPD, Thirumalai Medical Centre,
Cuddalore main road,
Pondicherry – 605004
Pondicherry
PONDICHERRY
605004
India |
| Phone |
09843591097 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SAKTHIBALAN M |
| Designation |
Consultant Physician |
| Affiliation |
Ki3 |
| Address |
Room no.1, Medicine OPD Thirumalai Medical Centre,
Cuddalore main road,
Pondicherry – 605004
Pondicherry
PONDICHERRY
605004
India |
| Phone |
09843591097 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SAKTHIBALAN M |
| Designation |
Consultant Physician |
| Affiliation |
Ki3 |
| Address |
Room no.1, Medicine OPD, Thirumalai Medical Centre,
Cuddalore main road,
Pondicherry – 605004
Pondicherry
PONDICHERRY
605004
India |
| Phone |
09843591097 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrutanjan Health Care Limited, Chennai |
|
|
Primary Sponsor
|
| Name |
Amrutanjan Health Care Limited |
| Address |
Plot No: 37, 38 & 39, SIDCO Pharmaceutical Complex, Alathur, Village, Thiruporur, Tamil Nadu |
| 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 |
| Sakthi Balan |
Thirumalai Medical centre |
Room no.1: Medicine OPD, Thirumalai Medical Centre and Ragavendra Diagnostic centre,
153, Cuddalore main road,
Pondicherry – 605004
Pondicherry
PONDICHERRY |
9843591097
saheerose@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ki3 Ethics committee for AYUSH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
For testing skin irritation potential |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amrutanjan pain balms |
Each gm contains, Karpura 10%
Yavani satva 1%
Pudinah 10%
Gandhapura patra taila 12%
Sarala 2%
Tailaparna taila 9%
Bhutrna 5%
Darusita taila 1%
Pudinah (Oil) 2%
Lavanaga taila 1%
Applied topically as single STAT dose of application. |
| Comparator Agent |
N/ap |
N/ap |
|
|
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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the severity mean scores for Erythema/dryness/wrinkles will be calculated and mean score of oedema will be calculated separately |
Day 1, 2 and 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Combined mean score calculation |
Day 8 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/09/2022 |
| Date of Study Completion (India) |
21/10/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="15" |
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
|
The subjects selected for this 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.
selection of the subjects were carried out as per the norms indicated in the protocol. 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. The patch is applied on the back or shoulder area of the subjects and will be in contact with the skin for 24 hours |