| CTRI Number |
CTRI/2025/04/085649 [Registered on: 25/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the glowing effect of Chanak and Masoor paste coating in Tanned skin |
|
Scientific Title of Study
|
Comparative clinical trial to assess the Varnya effect of Chanak (Cicer arietinum)
Lepa and Masoor(Lens esculenta) Lepa in Mukhatwaka Karshnya |
| 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 Krutika Hnasraj Suryawanshi |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre Nigdi Pune |
| Address |
PDEAs College of Ayurved and Research Centre 1st floor
Swasthavritta and Yoga department Sector no 25 Pradhikaran
Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8830899352 |
| Fax |
|
| Email |
krutikasuryawanshi17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepali Manore |
| Designation |
Associate Professor |
| Affiliation |
PDEAs College of Ayurved and Research Centre Nigdi Pune |
| Address |
PDEAs College of Ayurved and Research Centre 1st floor
Swasthavritta and Yoga department Sector no 25 Pradhikaran
Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9881650526 |
| Fax |
|
| Email |
dr.manore@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krutika Hnasraj Suryawanshi |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre Nigdi Pune |
| Address |
PDEAs College of Ayurved and Research Centre 1st floor
Swasthavritta and Yoga department Sector no 25 Pradhikaran
Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8830899352 |
| Fax |
|
| Email |
krutikasuryawanshi17@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre Nigdi Pune
Pin code 411044
India |
|
|
Primary Sponsor
|
| Name |
Dr Krutika Hansraj Suryawanshi |
| Address |
PDEAs College of Ayurved and Research Centre 1st floor
Swasthavritta and Yoga department Sector no 25 Pradhikaran
Nigdi Pune
Pin code 411044
India |
| 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 Krutika Hansraj Suryawanshi |
PDEAs Ayurved Rugnalay and Sterling multispeciality Hospital, Nigdi pradhikaran Pune |
PDEAs College of Ayurved and Research Centre, 1st floor,
Swasthavritta and Yoga department, Sector no 25, Pradhikaran,
Nigdi, Pune
Pune
MAHARASHTRA
411044
India
Pune
MAHARASHTRA |
8830899352
krutikasuryawanshi17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of College of Ayurved and Research Centre Nigdi Pune 411044 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mukhatwakakarshnya
Tanned skin |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Bhaishajya Ratnawali, Procedure details: Sensitivity test will be done before application on face by applying lepa on forearm & washing it just after drying The area will be then observed for 24
hours for any hypersensitivity reaction Before application of lepa face will be washed with normal water Mixture of 20gm of Powder with Milk will be prepared to make a paste Lepa will be applied on the face in morning Lepa will be applied against the direction of the hair follicles for better absorption When it will be started drying then face will be washed with pure water Lepa will be applied once in a day in the morning daily for one month)
(1) Medicine Name: Chanak, Reference: Raj Nighantu, Route: Topical, Dosage Form: Lepa Churna, Dose: 20(g), Frequency: od, Duration: 30 Days | | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Bhaishajya Ratnawali, Procedure details: Sensitivity test will be done before application on face by applying lepa on forearm & washing it just after drying The area will be then observed for 24
hours for any hypersensitivity reaction Before application of lepa face will be washed with normal water Mixture of 20gm of Powder with Milk will be prepared to make a paste Lepa will be applied on the face in morning Lepa will be applied against the direction of the hair follicles for better absorption When it will be started drying then face will be washed with pure water Lepa will be applied once in a day in the morning daily for one month)
(1) Medicine Name: Masoor, Reference: Kaiyadev Nighantu, Route: Topical, Dosage Form: Lepa Churna, Dose: 20(g), Frequency: od, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1) Volunteers having tanned skin and skin type 4, type 5, type 6 base on Fitzpatrick`s Scale.
2) Volunteers who has negative sensitivity test for the Lepa. |
|
| ExclusionCriteria |
| Details |
1) Volunteers having any skin disease like Psoriasis, Dermatitis, Herpes, Chickenpox, Eczema, SLE, Acne, and history of skin disease
2) Volunteers who are using some other cosmetics for tanned skin |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Chanak Lepa in comparison with Masoor Lepa applied daily for one month in Mukhatwaka Karshnya in the age group of 18 to 40 years. |
One month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nill |
Nill |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
05/05/2025 |
| 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="0"
Months="3"
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
|
There is great demand of Ayurveda due to its unique concept about beauty and effectiveness, cheaper and long lasting beauty therapy without any side effect. In Ayurveda we find so many drugs which are said to have Varnya karma. Varnya karma is to have a modifying effect on skin texture, it may include a positive effect on color, moisture, Luster, elasticity and skin discoloration. According to Samhita and Nighantu Masoor and Chanak both are effective as varnya (improves skin complexion). Lepa chikitsa helps in removing the Doshas locally and gives rise to natural skin complexion. This lepan chikitsa is simple, effective and also convenient to patients economically. |