| CTRI Number |
CTRI/2025/01/079549 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparing the Skin Benefits of Yavadi Lepa and Krishna Mrittika Lepa |
|
Scientific Title of Study
|
A Comparative clinical study on the varnya effect of YAVADI LEPA and KRISHNA MRITTIKA LEPA |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANJALI VERMA |
| Designation |
MD Scholar,Department Of Swasthavritta Evum Yoga |
| Affiliation |
Shri NPA Govt. Ayurved College Raipur (C.G.) |
| Address |
Department Of Swasthavritta Evum Yoga, Shri
NPA Govt. Ayurved College Raipur (C.G.)
Raipur
CHHATTISGARH
492010
India |
| Phone |
9340656734 |
| Fax |
|
| Email |
anjali34g@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sasmita Tripathy |
| Designation |
Reader,Department Of Swasthavritta Evum Yoga |
| Affiliation |
Shri NPA Govt. Ayurved College Raipur (C.G.) |
| Address |
Department Of Swasthavritta Evum Yoga, Shri
NPA Govt. Ayurved College Raipur (C.G.)
Raipur
CHHATTISGARH
492010
India |
| Phone |
8763650383 |
| Fax |
|
| Email |
sasmita1980@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anita Sharma |
| Designation |
Proff HOD ,Department Of Swasthavritta Evum Yoga |
| Affiliation |
Shri NPA Govt. Ayurved College Raipur (C.G.) |
| Address |
Department Of Swasthavritta Evum Yoga, Shri
NPA Govt. Ayurved College Raipur (C.G.)
Raipur
CHHATTISGARH
492010
India |
| Phone |
9827115211 |
| Fax |
|
| Email |
ansharma260@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri
NPA Govt. Ayurved College Raipur (C.G.)
Pincode-492010
India |
|
|
Primary Sponsor
|
| Name |
Department Of Swasthavritta Evum Yoga |
| Address |
Department Of Swasthavritta Evum Yoga, Shri
NPA Govt. Ayurved College Raipur (C.G.)
Pincode-492010
India |
| Type of Sponsor |
Other [Govt. Ayyurvedic College ,Raipur (C.G.)] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department Of Swasthavritta Evum Yoga |
Department Of Swasthavritta Evum Yoga, Shri
NPA Govt. Ayurved College Raipur (C.G.) |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr ANJALI VERMA |
Shri NPA Govt. Ayurved College and Hospital Raipur (C.G.) |
OPD NO. 6 Swasthvritta and
Yoga OPD 1st floor
Raipur
CHHATTISGARH |
9340656734
anjali34g@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the Principal , Shri Narayan Prasad Awasthi Govt. Ayurved College, Raipur (C.G.) 492010 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Krishna Mrittika, Reference: NA, Route: Topical, Dosage Form: Lepa Churna, Dose: 15(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yavadi Lepa, Reference: Chakradatta 55/50, Route: Topical, Dosage Form: Lepa Churna, Dose: 15(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1 The age group between the 18-30 year.
2 Volunteers are selected irrespective of their gender, religion, occupation, marital status, socio- economic status etc.
3 The volunteers willing to participate and who give written consent.
• Volunteers showing negative sensitivity test for the Lepa.
|
|
| ExclusionCriteria |
| Details |
1 Volunteers not willing for the study.
2 The age group below 18yr and above 30yr.
3 Volunteers suffering from any bacterial or fungal infection or any skin infestation eg psoriasis ,dermatitis etc.
4 Volunteers who are under medication with antifungal and antibacterial.
• History of drug induced pigmentation like phenytoin etc.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Yavadi Lepa and Krishna Mritika effectively reduced pigmentation and improved skin tone by reducing melanin levels. |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
These treatments enhanced skin texture, elasticity, moisture, & overall radiance.
|
60 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 term "Cosmetics" originates from the Greek word Kosmetike, meaning "technique of dress and ornament." In Ayurveda, Varna refers to complexion, which signifies health and beauty. Skin complexion depends on proper skin care, a healthy lifestyle, and natural products. Ayurveda emphasizes both external and internal beauty through practices such as Dinacharya, Ratricharya, and the use of medicinal herbs.
Hyperpigmentation, caused by excessive melanin production, leads to skin discoloration like freckles, age spots, and dark patches. The skin, being the body’s largest organ, serves functions like temperature regulation, protection, and aesthetic appearance.
Ayurvedic therapies, including Varnya Mahakashaya and Mukhkantikar Lepas(Yavadi Lepa), focus on enhancing skin tone. Lepas, or topical medicinal preparations, improve complexion and have therapeutic benefits. Mud(Krishna Mrittika), an essential element of nature, has healing, anti-inflammatory, and detoxifying properties, contributing to overall health and beauty. Harita Samhita describes five types of Bhumi (land) along with their properties (Gunas). According to the Drugs and Cosmetics Act, 1940, a cosmetic is any substance applied to the human body to enhance beauty, promote attractiveness, or alter appearance, including components used in cosmetics. |