| CTRI Number |
CTRI/2015/04/005698 [Registered on: 16/04/2015] Trial Registered Prospectively |
| Last Modified On: |
15/03/2023 |
| 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 Amritbindu Siddha Tailam for use as a rejuvenating oil on face in healthy human adults |
|
Scientific Title of Study
|
Efficacy and Safety Evaluation study of Amritbindu siddha tailum (Ayurvedic Oil Serum) for use a rejuvenating facial massage in healthy human adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KVM -SST-/012-14/001 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madhusudan KH |
| Designation |
Principal investigator |
| Affiliation |
Pranava Rejuvenation center |
| Address |
Pranava Rejuvenation Center
892/A, 3rd Cross, Ashok Nagar,
BSK 1st Stage, 2nd Block,
Bangalore 560050
Bangalore
KARNATAKA
560050
India |
| Phone |
9986010997 |
| Fax |
|
| Email |
pranavahealth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venkateshwarlu K |
| Designation |
co-investigator |
| Affiliation |
Anasuya Ayurvedic Center |
| Address |
Anasuya Ayurvedic Center,
50 feet Main Road, Hanumanth Nagar,
Bangalore- 560050
Bangalore
KARNATAKA
560050
India |
| Phone |
9945232107 |
| Fax |
|
| Email |
drvenkatesh64@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Venkateshwarlu K |
| Designation |
Co-investigator |
| Affiliation |
Anasuya Ayurvedic Center |
| Address |
Anasuya Ayurvedic Center,
50 feet Main Road, Hanumanth Nagar,
Bangalore- 560050
Bangalore
KARNATAKA
560050
India |
| Phone |
9945232107 |
| Fax |
|
| Email |
drvenkatesh64@gmail.com |
|
|
Source of Monetary or Material Support
|
| KVM Research Laboratories
No: 1, 6th Cross,
Elango Nagar,
Puducherry-605011
|
|
|
Primary Sponsor
|
| Name |
KVM Research Laboratories |
| Address |
No: 1, 6th Cross,
Elango Nagar,
Puducherry-605011
|
| Type of Sponsor |
Other [Manufacturers & Exporters of 100% Purely Natural Ayurvediya Products] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| KVM Research Laboratories |
No: 1, 6th Cross,
Elango Nagar,
Puducherry-605011 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Madhusudan KH |
Pranava Rejuvenation Center |
892/A, 3rd Cross, Ashok Nagar,
BSK 1st Stage,2nd Block,
Bangalore 560 050
Bangalore
KARNATAKA |
9986010997
pranavahealth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Prashanth Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy subjects whose skin types are representative of all VI Skin types as per the Fitzpatrik scale. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amritbindu Siddha Tailam |
A poly herbal tailam recommended to apply 4-6 drops over face once daily for 8 days |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 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 all 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 of facial skin |
On day 04 and 08 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To examine the influence of Amritbindu Ayurvediya Face Serum on sleeping pattern of the subject. |
On day 04 and 08 |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
20/04/2015 |
| 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="8" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
In an open label study, the efficacy and safety of Amritbindu siddha tailam as a rejuvenating facial massage will be investigating in healthy human voluteers. Twenty six participants whose skin types are representative of all VI skin types as per the Fitzpatrik scale will be receiving the treatment for 8 days (applying oil on face once daily). The efficacy of Amritbindu facial therapy will be assessing using efficacy and tolerability assessment tool on day 04 and 08. The influence of Amritbindu ayurvediya face serum on sleeping pattern will be assessing on day 04 and day 08. Subjects will be specifically asked about presence or absence of any side effects during the treatment. Amritbindu Siddha Tailam, a poly-herbal tailam containing the following ingredients: Vetiveria zizanioides (Vetiver), Aloevera, Ocimum tenuiflorum (Thulasi), Emblica officinalis (Amla), Psoralea corylifolia (Babchi), Asparagus racemosus (Shatavari), Glycyrrhiza glabra (Licorice), Rubia cordifolia (Manjishta), Curcuma amada (mango ginger) and base oil (coconut oil, sesame oil and clarified butter).
|