| CTRI Number |
CTRI/2025/04/084098 [Registered on: 04/04/2025] Trial Registered Prospectively |
| Last Modified On: |
04/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [nasyam (nasal errhines)] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to know the Benefits of Kumkumadi oil Nasya Therapy for Brighter and Healthy Skin in People Seeking Beauty Care. |
|
Scientific Title of Study
|
A Single Arm Clinical Trial To Assess Anti Melanogenic Effect and Serum Glutathione Level Changes
Of Kumkumadi Taila Nasya In Individuals Seeking Cosmetic Care
|
| 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 Nitya K R |
| Designation |
PG Scholar |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Panchakarma
Amrita School of Ayurveda
Amrita Vishwa Vidyapeetham, Clappana P.O. Kerala, India
Kollam
KERALA
690525
India |
| Phone |
9447448412 |
| Fax |
|
| Email |
nityaravindran1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kadambari P B |
| Designation |
Associate Professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Panchakarma
Amrita School of Ayurveda
Amrita Vishwa Vidyapeetham, Clappana P.O. Kerala, India
Kollam
KERALA
690525
India |
| Phone |
9746004107 |
| Fax |
|
| Email |
kadambaripb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Parameswaran Namboothiri |
| Designation |
Professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Panchakarma
Amrita School of Ayurveda
Amrita Vishwa Vidyapeetham, Clappana P.O. Kerala, India
Kollam
KERALA
690525
India |
| Phone |
9496096694 |
| Fax |
|
| Email |
nambu24@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Nitya K R |
| Address |
Department of Panchakarma
Amrita School of Ayurveda
Amrita Vishwa Vidyapeetham, Clappana P.O. Kerala, India - 690 525. |
| 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 Nitya K R |
Amrita School of Ayurveda |
Department of Panchakarma
Amrita School of Ayurveda
Amrita Vishwa Vidyapeetham, Amritapuri, Clappana P.O. Kerala, India - 690 525.
Kollam
KERALA |
9447448412
nityaravindran1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita Insitutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals Seeking Cosmetic Care |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Astanga hrdaya edited by dr Brhmanand Tripati hindi commentary published by choukamba Varanasi 2010 , sutrastana chapter 20 verse 4 , Procedure details: •After the initial screening of individuals and making them aware of the risks and benefits of the study, informed consent should be obtained from the participants
•Individuals are instructed to avoid using cosmetic products at time of treatment as well as 7 days prior to treatment and also for about 7 days after treatment.(Even normal cosmetic products are to be avoided during this period)
•Nasya karma is done by administering 2ml of Kumkumadi taila in each nostril after purvakarma
•The skin color probe of Derma Lab Combo is used for assessing the Melanin of the skin before the treatment (1st day) and after 7 days of treatment (7th day) as well as on the 14th day.
•Reduced Glutathione (GSH) Assay Kit is used for assessing the Glutathione level before the treatment (1st day) and after 14 days of treatment (14th day) as follow up
)
(1) Medicine Name: Kumkumadi Taila, Reference: ) Astanga hrdaya edited by dr brhmanand tripati hindi commentary published by choukamba Varanasi 2010 , uttarastana chapter 32 verse 27-30, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1) Individuals who are of age group 20-40,equal number of males and females
2) Individuals seeking cosmetic care
3) Those who are indicated for Nasya
4) Those who seek the treatment should avoid using cosmetic products (even daily use products such as sunscreen, moisturisers, powders etc) for advised period of time. |
|
| ExclusionCriteria |
| Details |
1) Pregnant indviduals
2) Individuals who have hyper pigmentation due to systemic diseases, hormonal imbalance such as melasma, thyroid disorders, PCOS.
3) Individuals who are undergoing/underwent skin care treatments like Skin Bleaching, Facial etc and who are using cosmetic products.
4) Individuals who had undergone skin brightening treatment like Chemical peels, Laser treatments, Topical Treatments like Vit. C, Hydroquinone, Glutathione IV
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the reduction in melanin level using skin color probe in Derma lab combo |
-1st day of treatment (before treatment)
-7th day of treatment(after treatment)
-14th day (as follow up) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the elevation in glutathione level using Reduced Glutathione (GSH) Assay Kit |
-1st day of treatment (before treatment)
-14th day |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The primary purpose of the study is to assess the changes in melanin level in the skin (mainly facial skin) after the usage of Kumkumadi taila in nasya form as there are studies that prove the Antimelanogenic property of Kumkumadi taila in external application. Recent years the usage of Glutathione in the form of IV,Oral pills,cream are widely used for skin brightening as some studies proved its antimelanogenic effect thus helps in skin brightening.But the usage of Glutathione comes with side effects. this study is proposed to explore the Antimelanogenic effect and any changes in serum Glutathione level using Kumkumadi taila as nasya. The Null Hypothesis states that there is no Antimelanogenic effect after administration of Kumkumadi taila and the Alternative hypothesis states that There is Antimelanogenic effect after administration of Kumkumadi taila . |