| CTRI Number |
CTRI/2025/02/081251 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy and safety evaluation study of Herb-o-ville Sneha Massage Oil for healthy human adults |
|
Scientific Title of Study
|
Efficacy and safety evaluation study of Herb-o-ville Sneha Massage Oil for use as a rejuvenating massage tailum in healthy human adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRoshany V MBBS MD |
| Designation |
Consultant Dermatologist |
| Affiliation |
DK Elite Health Care Center |
| Address |
First Floor 370, Cuddalore Road, Nainar Mandapam, Velrampet, Puducherry
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9943805988 |
| Fax |
|
| Email |
roshanysakthibalan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRoshany V MBBS MD |
| Designation |
Consultant Dermatologist |
| Affiliation |
DK Elite Health Care Center |
| Address |
First Floor 370, Cuddalore Road, Nainar Mandapam, Velrampet, Puducherry
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9943805988 |
| Fax |
|
| Email |
roshanysakthibalan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRoshany V MBBS MD |
| Designation |
Consultant Dermatologist |
| Affiliation |
DK Elite Health Care Center |
| Address |
First Floor 370, Cuddalore Road, Nainar Mandapam, Velrampet, Puducherry
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9943805988 |
| Fax |
|
| Email |
roshanysakthibalan@gmail.com |
|
|
Source of Monetary or Material Support
|
| KVM Research Labortories,Midam Ashram, RS No.144/5, Earaikarai road, Kothapurinatham, Puducherry -605102 |
|
|
Primary Sponsor
|
| Name |
KVM Research Laboratories |
| Address |
Midam Ashram, RS NO.144, 5 Earaikarai road Kothapurinatham Puducherry |
| 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 |
| DrRoshany V |
DK Elite Health Care Centre |
Room. No. 3. Dermatology OP, DK Elite Health care centre, First Floor, 370, Cuddalore Road, Nainar Mandapam, Velrampet, Puducherry, 605004
Pondicherry
PONDICHERRY |
9943805988
roshanysakthibalan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethique De La Nature |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
30 healthy adult volunteers will be selected for the study. The volunteers selected for this study will be healthy females and males, aged between 18 and 55 years old. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Herb-o-ville SNEHA massage Oil, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -Herb-o-ville body massage Oil is a poly herbal formulation composed of 14 roots, fruits, stem, leaves and seeds described in the First Schedule of the AYUSH ministry infused in a medium of sesame oil and milk
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Healthy individuals between the age group of 15-55 years old, whose skin types are representative of type III, IV, V, VI skin types as per the Fitzpatrik scale.
Being mentally competent and able to understand all study requirements and sign the informed consent form.
|
|
| ExclusionCriteria |
| Details |
Subjects with severe liver, renal, cardiac or brain diseases.
Pregnant or lactating women or women of childbearing potential whom are not
practicing a reliable form of birth control (either with IUD or with stable usage of oral contraceptives).
Unable to complete follow up.
Allergic to any medication.
With a history of alcohol and/or drug abuse.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To examine the effect of the test substance on the efficacy and tolerability on skin, To examine the effect of the test substance on the efficacy and tolerability on skin |
Day 0, Day 7 and Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome measures
To examine the influence of test substance on muscle stiffness, skin smoothness and joint movements
|
Day 0, Day 7 and Day 14 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="14" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Herb-o-ville body massage Oil is a poly herbal formulation composed of 14 roots, fruits, stem, leaves and seeds described in the First Schedule of the AYUSH ministry infused in a medium of sesame oil and milk. Pre-Clinical Tests performed at a Dept. of Ayush, Govt. Approved Laboratory testing facility and our GMP certified Ayurvedic Drug Manufacturing unit for the following analytical parameters 1) Descriptive studies: Color, Odor, Touch 2) Weight per ml 3) Microbiological Contamination: Total Bacterial count,
Total Fungal count.
4) Heavy metal test
2 Trial Objectives To evaluate the efficacy and safety of a rejuvenating Ayurvedic facial massage using an oil serum in healthy human adults. To study the irritation potential of a rejuvenating Ayurvedic facial massage using an oil serum in healthy human volunteers using dermatological evaluation by single occlusive patch test method. |