| CTRI Number |
CTRI/2023/03/051035 [Registered on: 24/03/2023] Trial Registered Prospectively |
| Last Modified On: |
26/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To assess the Skin sensitivity of Amrutanjan pain balm |
|
Scientific Title of Study
|
A Cross over, Double blinded, Interventional study to evaluate the skin sensitivity, safety and tolerability of two types of Amrutanjan Pain Balm in healthy subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AMRUTPB/02/23 Version:1.1, dated 01.03.2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Sakthi Balan MD |
| Designation |
Consultant and PI |
| Affiliation |
knowledge centre for innovation, integrity and implementation |
| Address |
Sri Thirumalai Medical Centre No 408 Cuddalore Road Nainarmandapan Puducherry
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Sakthi Balan MD |
| Designation |
Consultant and PI |
| Affiliation |
knowledge centre for innovation, integrity and implementation |
| Address |
Sri Thirumalai Medical Centre No 408 Cuddalore Road Nainarmandapan Puducherry
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9443627700 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Sivakumar |
| Designation |
CEO |
| Affiliation |
knowledge centre for innovation, integrity and implementation |
| Address |
Regus Centre Level 2 Altius Block No 1 SIDCO Industrial Estate Chennai
Chennai
TAMIL NADU
600032
India |
| Phone |
9003109416 |
| Fax |
|
| Email |
venkat_ani2007@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Amrutanjan Health Care Limited, Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
Amrutanjan Health Care Limited, Tamil Nadu, India. |
| Address |
Mylapore Chennai 600004 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr M Sakthi Balan |
Thirumalai Medical Centre, Puducherry |
Room no.1: Medicine OPD, Thirumalai Medical Centre and Brindas Skin Clinic(bussy street), 153, Cuddalore main road, Pondicherry – 605004
Pondicherry
PONDICHERRY |
9443627722
saheerose@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ki3 Ethics Committee for AYUSH |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
For testing skin irritation potential |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Amrutanjan pain balm, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 0.25(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: (2) Medicine Name: Amrutanjan pain balm, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 0.25(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Amrutanjan pain balm, modified composition, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 0.25(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: (2) Medicine Name: Amrutanjan pain balm, modified composition, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 0.25(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex aged above 18 years.
2. Patients who are able to understand written and/or verbal instructions and are ready to comply with all study requirements with a willingness to participate and give written informed consent voluntarily.
|
|
| ExclusionCriteria |
| Details |
1. Past history of allergy, asthma and atopy.
2. Known allergy to compounds of investigational product.
3. Participation in an investigational drug trial in the 30 days prior to the screening visit.
4. Patients of vulnerable group (children, lactating mother, elderly >80 years, handicapped, seriously ill, mentally challenged).
5. Subjects with known history of Sinusitis, Migraine. |
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The following parameters will be assessed for each subject;
1. Erythema/dryness/wrinkles
2. Oedema
3. Mean Irritation Index
Clinical score for Erythema/ Dryness/Wrinkles/oedema : scale 0-4
Scale: Reaction
0 - No reaction
1 - Very slight erythema/dryness with shiny appearance/very slight oedema
2 - Slight erythema/dryness/wrinkles/slight oedema
3 - Moderate erythema/dryness/wrinkles/moderate oedema
4 - Severe erythema/wrinkles/scales/severe oedema
|
Time Frame: Baseline (0 minute), 5 min., 15 min., 30 min., 1 hr, 2 hr, 4 hr, 6 hr and 8 hrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to onset of skin irritation/burning sensation Time frame: 0-8 hrs post dose
Time taken for complete relief of skin irritation/burning sensation.
User perception will be assessed with a 5- point Likert Satisfaction scale on the following points:
1. Ease of application,
2. Stickiness 3. Greasiness and 4. Ease of spreading.
To monitor for any adverse events during the study period.
|
Time frame: 0-8 hrs post dose
|
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "12"
Final Enrollment numbers achieved (India)="12" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
31/03/2023 |
| Date of Study Completion (India) |
25/04/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="20" |
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 who fulfilled the inclusion and exclusion criteria will be enrolled in the study. 12 healthy adult subjects will be divided into 2 arms with 6 in each. Six Subjects will be topically applying the pain balm of product A and six subjects will be topically applying Product B over forehead region and they will be in house for a period of 8 hours and monitored at 5 min., 15 min., 30 min., 1 hr, 2 hr, 4 hr, 6 hr and 8 hrs for clinical scores of erythema/dryness/wrinkles/oedema. Then a wash out period of 5 days is given. Patients with any erythema/ oedema will not be included for the Subsequent study procedure. Then, the subjects will be crossed over and the same procedures will be repeated.
The following parameters will be assessed for each subject;
Erythema/dryness/wrinkles
Oedema
Mean Irritation Index
|