| CTRI Number |
CTRI/2021/09/036560 [Registered on: 16/09/2021] Trial Registered Prospectively |
| Last Modified On: |
24/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
effect of Kanak taila in reducing wrinkles and promoting skin brightening. |
|
Scientific Title of Study
|
A Clinical Study to assess the safety and efficacy of kanaka taila for its anti wrinkle and skin brightening effect in healthy volunteers |
| Trial Acronym |
KT2021 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sumit Nathani |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Dept of Dravyaguna , National Institute of Ayurveda,Amer Road
Jaipur
RAJASTHAN
302002
India |
| Phone |
7665809886 |
| Fax |
|
| Email |
sumitnathani2@rediff.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sumit Nathani |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Dept of Dravyaguna , National Institute of Ayurveda,Amer Road
RAJASTHAN
302002
India |
| Phone |
7665809886 |
| Fax |
|
| Email |
sumitnathani2@rediff.com |
|
Details of Contact Person
Public Query
|
| Name |
Sumit Nathani |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Dept of Dravyaguna , National Institute of Ayurveda,Amer Road
RAJASTHAN
302002
India |
| Phone |
7665809886 |
| Fax |
|
| Email |
sumitnathani2@rediff.com |
|
|
Source of Monetary or Material Support
|
| Ms Ozone Pharmaceuticals Ltd
|
|
|
Primary Sponsor
|
| Name |
Ms Ozone Pharmaceuticals Ltd |
| Address |
1, LSC, Block A-3, Janakpuri
New Delhi- 110058 |
| 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 |
| Sumit Nathani |
NIA Hospital |
OPD no 19,Dravyaguna Department, Amer Road, Jaipur
Jaipur
RAJASTHAN |
7665809886
sumitnathani2@rediff.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, NIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Wrinkles and skin darkening |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kanak Tail, Reference: Kshudra rog adhikar, Chakradutta, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: Nil |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Volunteers meeting the following criteria will be enrolled:
ï‚· Between the age of 18-65 years;
ï‚· Available for 3 study visits;
 Fine lines/wrinkles: Allergen fine lines (≥ grade 1)
ï‚· Individuals who are willing to provide written informed consent
ï‚· Individuals willing not to wear makeup or use skin care products other
than the study products the day of the study visits;
ï‚· Individuals willing to discontinue using current skincare products and
only use study products for the study duration.
ï‚· Individuals willing to refrain from sun tanning / sun bathing for the study
duration
|
|
| ExclusionCriteria |
| Details |
Volunteers will be excluded from the study if they meet any of the criteria listed
below:
ï‚· Any medically diagnosed chronic skin problems on their face (e.g.,
psoriasis, eczema, seborrheic dermatitis, or chronic cystic acne, etc.)
ï‚· Diagnosed with known allergies to facial skin care products
ï‚· Have undergone dermatological skin rejuvenation procedures such as
light-therapies (lasers, radiofrequency and other lights treatments ) or
such as collagen or other facial tissue augmentation, fillers, or retail
micro dermabrasion on the face within the last 1 year preceding the
baseline visit and intended to receive them during the study period
ï‚· Have planned surgeries or invasive procedures during the course of the
study.
ï‚· Excessively tanned face before the baseline visit and who intend to
excessively be exposed to sun.
ï‚· Have sunburned skin |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy Endpoints
ï‚· Reduction of fine lines according to Allergan Fine Lines Scale (Grade
0 to 4)
ï‚· Subjective Improvement in fine lines, skin whitening and skin
smoothening scoring
|
baseline, 4 weeks and 8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Safety/Tolerability Endpoints
ï‚· No visible Erythema, oedema, , scaling, dryness, burning, tingling
stinging & itching
ï‚· Monitoring of adverse events throughout the course of the study.
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
22/09/2021 |
| Date of Study Completion (India) |
20/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
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
|
Introduction
Healthy skin showcase not only the overall physical health of the
individual but also has the positive impact on the self esteem of the
individual.
Skin aging is a complex biological phenomenon consisting of two
independent clinically and biologically distinct processes, namely “intrinsic
aging†and “extrinsic aging.†Extrinsic aging (including “photoagingâ€) is the
result of exposure to outdoor elements, primarily ultraviolet (UV)
irradiation. Photoaged skin shows a variety of age-associated clinical
alterations, including deep wrinkles, sallow discoloration, and irregular
pigmentation. Recently, it has been revealed that reactive oxygen species
(ROS) produced excessively in the cells are involved in the process of skin
aging caused by UV exposure.
Ayurveda provides various solutions to these conditions in form of certain
topical formulations.
Kanak taila is a classical preparation mentioned in kshudra rogadhikar of
Chakradatta.
i
This tail is indicated in conditions of vali (wrinkles) and for improvement of
overall skin tone .
Present study aims to Evaluate and Document the Efficacy and Safety of
local application of kanak taila in treatment of wrinkles and for skin
whitening .
Test Drug
Kanaka Taila- Oil will be prepared and provided by Ozone Pharmaceutical
Ltd.
This oil will be analyzed in a NABL accredited laboratory for various
physiochemical parameters relating to its identity, Purity and Strength .
Test Drug
Ingredients
Composition
S.No Ingredients Botanical Name Part to be
Used
1. Madhuk Madhuka indica heartwood
2. priyangu Callicarpa macrophylla flowers
3. manjishtha Rubia cordifolia roots
4. chandan Santanalum album heartwood
5. Utpal Nelumbo nucifera flowers
Page 3 of 14
6. kesar Crocus sativus stigma
7. Til Sesamum indicum Seed oil Study Design
ï‚· Single arm , prospective, open label, clinical trial
ï‚· Home use: two times per day; 7 days per week
ï‚· Duration of Treatment : 8 weeks
ï‚· Study visits: Baseline, 4 and 8 weeks
ï‚· Clinical assessments: Baseline, 4 and 8 weeks
ï‚· Tolerability : Baseline, 4 and 8 week Methodology
For the proposed work Ethical clearance will be taken from Institutional
Ethical Committee NIA, Jaipur. And trial will be registered in CTRI, New
Delhi
o After registration in CTRI, 50 apparently healthy individuals fulfilling
the inclusion criteria will be recruited for the study at O.P.D. basis in
NIA Arogyashala. 50 subjects will be selected on screening visit and a
written informed consent will be taken from subjects for their
participation in the study. Subjects will be instructed not to wear any
facial makeup or apply any skin care products or sunscreen on the face
and neck on the day of the baselinevisit. On the Baseline visit after
acclimatization of 15 min, sides and front photograph will be taken.
Page 5 of 14
Baseline Grading of fine lines will be done according to the Allergan
Fine Lines Scale (grade 0 to 4). Skin whitening and smoothening at the
test site and improvement in fine lines will be evaluated subjectively by
the investigator and by the subjects on 0 to 3 scale. Baseline scoring for
Tolerance and Safety will be done on 0 – 3 point assessment scale
(Erythema, edema, scaling,dryness by investigator & , burning, stinging
& itching by Subject himself).
o For the day of the 4 and 8 week visits subject will also be instructed to
apply the study facial cream at least 2 hours prior to the study visits. They
will also be instructed to discontinue using all of their current skin care
products such as serums and moisturizers except the study product for the
duration of the treatment with test drug. The study drug will be used at
home twice per day for the 8 week duration of the study.
o At each Follow up, subject will be given 15 minute acclimation periods,
product use will be discussed. Documentation of adverse events and
protocol deviation will be done.
Assessment
Parameters
ï‚· Photographs at baseline, 4, & 8 weeks:
ï‚· Expert clinical grading (face):
o Face (cheeks): Allergan Fine Lines Scale (grade 0 to 4)
o Skin whitening and smoothening at the test site and improvement in fine
lines will be evaluated subjectively by the investigator and by the subjects
on 0 to 3 scale. ii
 Tolerance (0 – 3 point assessment scale)iii
:
Erythema, edema, scaling,dryness, burning, stinging & itching |