| CTRI Number |
CTRI/2025/04/085986 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Nasya [nasal errhines]] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Improvement of Facial skin quality by nasal medication. |
|
Scientific Title of Study
|
Evaluation of Anu taila pratimarsha
nasya in facial skin quality - Pre and Post test study |
| Trial Acronym |
NIl |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anushka Malekar |
| Designation |
Pg scholar |
| Affiliation |
Amrita school of ayurveda |
| Address |
Department of kayachikitsa amrita school of ayurveda amrita vishwa vidyapeetham clappanna p.o kerala India 690525
Kollam
KERALA
690525
India |
| Phone |
8788426507 |
| Fax |
|
| Email |
anushkam163@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devipriya soman |
| Designation |
Associate Professor |
| Affiliation |
Amrita school of ayurveda |
| Address |
Department of kayachikitsa amrita school of ayurveda amrita vishwa vidyapeetham clappanna p.o kerala India 690525
Kollam
KERALA
690525
India |
| Phone |
9495638076 |
| Fax |
|
| Email |
priya3656@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devipriya soman |
| Designation |
Associate Professor |
| Affiliation |
Amrita school of ayurveda |
| Address |
Department of kayachikitsa amrita school of ayurveda amrita vishwa vidyapeetham clappanna p.o kerala India 690525
Kollam
KERALA
690525
India |
| Phone |
9495638076 |
| Fax |
|
| Email |
priya3656@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita school of ayurveda Amrita vishwa vidyapeetham clappanna p.o kerala india 690525 |
|
|
Primary Sponsor
|
| Name |
Dr Anushka Malekar |
| Address |
Department of Kayachikitsa Amrita school of Ayurveda Amrita vishwa vidyapeetham clappanna p.o kerala india 690525 |
| Type of Sponsor |
Other [[self]] |
|
|
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 Anushka |
Amrita school of ayurveda |
Department of Kayachikitsa Amrita school of ayurveda Amrita vishwa vidyapeetham clappanna p.o kerala India 690525
Kollam
KERALA |
8788426507
anushkam163@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
FACIAL SKIN QUALITY |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Astanga Samgraha of Vagbhata Volume 1 - Sutrasthana,Author-Prof K R Srikanta Murthy,publisher-chaukhambha Orientalia year 2009 ,Chapter 21 , Verse no. 11., Procedure details: Before performing Nasya, the person should wash their face with lukewarm water. Have them lie down comfortably, then ask another person to use a dropper to first add 10 drops of Anu Taila into one nostril. Tell the individual to close the other nostril & take a deep inhalation. Similarly, repeat the same procedure for the other nostril. If the individual feels like it, they can spit out any excess oil or secretions.)
(1) Medicine Name: Anu taila, Reference: Ashtanga hridaya of vagbhata Author K.R Srikantha Murthy Publisher : Chaukhambha Orientalia. year 2009 ; sutra sthana chapter no.20 shloka no.37-38, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 20(drops), Frequency: hs, Duration: 10 Weeks |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Healthy individuals who have given consent for clinical trial .
Both male and female between the ages of 20 – 40 years.
|
|
| ExclusionCriteria |
| Details |
With the history of any skin disease like psoriasis dermatitis herpes eczema ringworm .
History of hypersensitivity to drugs .
Female on OCP , pregnant women and lactating women .
Who are on any hormonal therapy .
Individuals who have not undergone any cosmetic procedures or topical treatments in the past 3- 6 months .
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in parameter skin color videoscope elasticity hydration and skin glow before and after treatment. |
1st day of treatment [ before treatment]
71st day of treatment [after treatment] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 3 |
|
Date of First Enrollment (India)
|
01/06/2025 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Facial skin quality plays a key role in human attractiveness, impacting perceptions of health, youthfulness, and emotional well-being. Poor skin quality can affect self-image and social interactions. While current treatments include rejuvenation procedures, cosmeceuticals, and supplements, many users experience side effects—most commonly on the face, such as acne and redness.Emergent perceptual categories (EPCs) for skin quality include: skin tone evenness, surface evenness, firmness, and glow.In Ayurveda, Anu Taila is traditionally used to nourish and improve skin health, balancing the Tridoshas. As per Ashtanga Hridaya and Charaka Samhita, daily Pratimarsha Nasya with Anu Taila enhances skin firmness, glow, and overall vitality without dietary restrictions or side effects. The typical dose is 1–2 Bindu per nostril.A pre-post clinical trial at the Kayachikitsa OPD of Amrita School of Ayurveda will evaluate this treatment. 24 eligible participants will administer 1 ml of Anu Taila (0.5 ml per nostril ,1 bindu = 0.5ml and 2 bindu = 1ml ) daily for 10 weeks. Skin parameters—color, elasticity, hydration, surface characteristics, and glow—will be assessed before and after treatment to evaluate efficacy. |