| CTRI Number |
CTRI/2018/08/015309 [Registered on: 13/08/2018] Trial Registered Prospectively |
| Last Modified On: |
11/08/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to identify the benefits of Tanusha- Ayurvedic Face Scrub as a facial exfoliating product |
|
Scientific Title of Study
|
A Prospective, Randomized, Self-Controlled 14 day Clinical Study to evaluate the anti-aging effect of topical application of Tanusha- Ayurvedic polyherbal Formulation for Rejuvenation of facial skin. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sajitha K |
| Designation |
PI |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital |
| Address |
Room No.7, Dept of Swashta Vritta, Yoga OPD, Survey No. 189, O.B. Chordahalli, Udayapura Post, Kanakapura Rd,
Bangalore South, Bengaluru
Bangalore
KARNATAKA
560082
India |
| Phone |
07760987722 |
| Fax |
|
| Email |
sajithak96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sushrut Badhe |
| Designation |
CEO |
| Affiliation |
KVM Research Laboratories |
| Address |
KVM Research Laboratories, RS No.144/5, Errikkarai Road
Kothapurinatham village
Pondicherry
PONDICHERRY
605102
India |
| Phone |
09790635964 |
| Fax |
|
| Email |
sushrutayurveda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sushrut Badhe |
| Designation |
CEO |
| Affiliation |
KVM Research Laboratories |
| Address |
KVM Research Laboratories,
RS No.144/5, Errikkarai Road
Kothapurinatham village
Pondicherry
PONDICHERRY
605102
India |
| Phone |
09790635964 |
| Fax |
|
| Email |
sushrutayurveda@gmail.com |
|
|
Source of Monetary or Material Support
|
| KVM Research Laboratories, RS No.144/5, Errikkarai Road
Kothapurinatham village, Puducherry-605102 |
|
|
Primary Sponsor
|
| Name |
KVM Research Laboratories |
| Address |
Midam Ashram, RS No.144/5, Erikkarai road, KP Natham, Puducherry |
| Type of Sponsor |
Research institution |
|
|
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 Sajitha K |
Sri Sri College of Ayurvedic Science and Research |
Room No.7, Dept of Swasthavritta, Yoga OPD, survey No. 189, O.B. Chordahalli, Udayapura Post, Kanakapura Rd,
Bangalore South, Bengaluru, Karnataka 560082
Bangalore
KARNATAKA |
07760987722
sajithak96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Any male or female adults between 18-65 years of all skin types, sensitive acne prone skin and irritated skin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Tanusha Exfoliating Face Scrub |
TOTAL duration of therapy: 14 Days
Dose: 1 g of Tanusha Face scrub is to be made into a paste with water and applied topically on face
Frequency route of administration : Twice daily
Tanusha Exfoliating face scrub is a 100% natural ayurvedic face wash powder made of the follwing herbs and soils,
curcuma amada, psoralea corylifolia, phlyannthus emblica, terminalia chebula, terminalai chebula young, cesalpinia bonduc, abie webiana, cyperus rotundus, hydichium spicatum, pistacia intergerrima, acorus calamus, cinnamomum ceciodaphne and Fullers eart and red soil
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Any male or female adults between 18-60 years
2.Subject who is willing to give informed consent and is able to comply with all trial requirements.
3.Subjects with all skin types
4.Subjects who have sensitive and acne prone skin.
5.Subjects who have hyper pigmentation problems with skin irritation.
|
|
| ExclusionCriteria |
| Details |
1.Subjects with chronic diseases like severe liver, renal, cardiac or brain diseases.
2.Pregnant or lactating women
3.Subjects that are Allergic to any medication
4.With a history of alcohol and/or drug abuse
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of 14 day application of Tanusha Ayurvedic formulation in facial skin repair and rejuvenation |
Day 0, Day 7 and Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess its efficacy in removing marks and acne. |
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
17/08/2018 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A clincial trial is to be conducted to assess the effect of 14 day Clinical Study to Evaluate the
Efficacy of Ayurvedic polyherbal formulation Tanusha as a paraben-free &
poly-ethylene bead-free exfoliating anti-aging strategy for improving the
appearance of facial skin is proposed. Total number of patients is 30 and as it is a single arm trial, all patients will be administered the same intervetion. 1 g of
Tanusha to be mixed with ordinary water and form paste for topical application
on facial skin. The data gathered from patient assessment on Day 0, Day 7 and Day 14 is to be assessed and analyzed and the results and discussions are to be recorded. This study will be
conducted in compliance with the protocol approved by the IEC. No deviation
from the protocol will be implemented without the prior review and approval of
the IEC except where it may be necessary to eliminate an immediate hazard to a
research subject. In such case, the deviation will be reported to the IEC as
soon as possible. |