effect of Kanak taila in reducing wrinkles and promoting skin brightening.
- Conditions
- Wrinkles and skin darkening
- Registration Number
- CTRI/2021/09/036560
- Lead Sponsor
- Ms Ozone Pharmaceuticals Ltd
- Brief Summary
IntroductionHealthy skin showcase not only the overall physical health of theindividual but also has the positive impact on the self esteem of theindividual.Skin aging is a complex biological phenomenon consisting of twoindependent clinically and biologically distinct processes, namely “intrinsicaging†and “extrinsic aging.†Extrinsic aging (including “photoagingâ€) is theresult of exposure to outdoor elements, primarily ultraviolet (UV)irradiation. Photoaged skin shows a variety of age-associated clinicalalterations, including deep wrinkles, sallow discoloration, and irregularpigmentation. Recently, it has been revealed that reactive oxygen species(ROS) produced excessively in the cells are involved in the process of skinaging caused by UV exposure.Ayurveda provides various solutions to these conditions in form of certaintopical formulations.Kanak taila is a classical preparation mentioned in kshudra rogadhikar ofChakradatta.iThis tail is indicated in conditions of vali (wrinkles) and for improvement ofoverall skin tone .Present study aims to Evaluate and Document the Efficacy and Safety oflocal application of kanak taila in treatment of wrinkles and for skinwhitening .Test DrugKanaka Taila- Oil will be prepared and provided by Ozone PharmaceuticalLtd.This oil will be analyzed in a NABL accredited laboratory for variousphysiochemical parameters relating to its identity, Purity and Strength .Test DrugIngredientsCompositionS.No Ingredients Botanical Name Part to beUsed1. Madhuk Madhuka indica heartwood2. priyangu Callicarpa macrophylla flowers3. manjishtha Rubia cordifolia roots4. chandan Santanalum album heartwood5. Utpal Nelumbo nucifera flowersPage 3 of 146. kesar Crocus sativus stigma7. Til Sesamum indicum Seed oil
Study Designï‚· Single arm , prospective, open label, clinical trialï‚· Home use: two times per day; 7 days per weekï‚· Duration of Treatment : 8 weeksï‚· Study visits: Baseline, 4 and 8 weeksï‚· Clinical assessments: Baseline, 4 and 8 weeksï‚· Tolerability : Baseline, 4 and 8 week
MethodologyFor the proposed work Ethical clearance will be taken from InstitutionalEthical Committee NIA, Jaipur. And trial will be registered in CTRI, NewDelhio After registration in CTRI, 50 apparently healthy individuals fulfillingthe inclusion criteria will be recruited for the study at O.P.D. basis inNIA Arogyashala. 50 subjects will be selected on screening visit and awritten informed consent will be taken from subjects for theirparticipation in the study. Subjects will be instructed not to wear anyfacial makeup or apply any skin care products or sunscreen on the faceand neck on the day of the baselinevisit. On the Baseline visit afteracclimatization of 15 min, sides and front photograph will be taken. Page 5 of 14Baseline Grading of fine lines will be done according to the AllerganFine Lines Scale (grade 0 to 4). Skin whitening and smoothening at thetest site and improvement in fine lines will be evaluated subjectively bythe investigator and by the subjects on 0 to 3 scale. Baseline scoring forTolerance 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 toapply the study facial cream at least 2 hours prior to the study visits. Theywill also be instructed to discontinue using all of their current skin careproducts such as serums and moisturizers except the study product for theduration of the treatment with test drug. The study drug will be used athome 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 andprotocol deviation will be done.AssessmentParameters Photographs at baseline, 4, & 8 weeks: 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 finelines will be evaluated subjectively by the investigator and by the subjectson 0 to 3 scale. ii Tolerance (0 – 3 point assessment scale)iii:Erythema, edema, scaling,dryness, burning, stinging & itching
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
- Volunteers meeting the following criteria will be enrolled:  Between the age of 18-65 years;  Available for 3 study visits;  Fine lines/wrinkles: Allergen fine lines (≥ grade 1)  Individuals who are willing to provide written informed consent  Individuals willing not to wear makeup or use skin care products other than the study products the day of the study visits;  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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy Endpoints baseline, 4 weeks and 8 weeks smoothening scoring baseline, 4 weeks and 8 weeks ï‚· Reduction of fine lines according to Allergan Fine Lines Scale (Grade baseline, 4 weeks and 8 weeks 0 to 4) baseline, 4 weeks and 8 weeks ï‚· Subjective Improvement in fine lines, skin whitening and skin baseline, 4 weeks and 8 weeks
- Secondary Outcome Measures
Name Time Method Safety/Tolerability Endpoints ï‚· No visible Erythema, oedema, , scaling, dryness, burning, tingling
Trial Locations
- Locations (1)
NIA Hospital
🇮🇳Jaipur, RAJASTHAN, India
NIA Hospital🇮🇳Jaipur, RAJASTHAN, IndiaSumit NathaniPrincipal investigator7665809886sumitnathani2@rediff.com