| CTRI Number |
CTRI/2025/07/091117 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Other (Specify) [Cosmetic] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Development of Raktachandanadi skin serum for enhancement of skin brightness in healthy volunteers. |
|
Scientific Title of Study
|
Development of innovative raktachandanadi skin serum and its exploratory clinical evaluation for kantivardhan action’’ |
| 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 Bhujbal Mahesh Dattatray |
| Designation |
M.D. (Ayurveda) |
| Affiliation |
Bharati Vidyapeeth Deemed to be University, College of Ayurveda and Hospital, Pune |
| Address |
Raykarnagar, Dhayari
Dhanakawadi, Pune 411043
Pune
MAHARASHTRA
411041
India |
| Phone |
09766895511 |
| Fax |
|
| Email |
vdmahesh@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhujbal Mahesh Dattatray |
| Designation |
M.D. (Ayurveda) |
| Affiliation |
Bharati Vidyapeeth Deemed to be University, College of Ayurveda and Hospital, Pune |
| Address |
Raykarnagar, Dhayari
Dhanakawadi, Pune 411043
Pune
MAHARASHTRA
411041
India |
| Phone |
09766895511 |
| Fax |
|
| Email |
vdmahesh@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhujbal Mahesh Dattatray |
| Designation |
M.D. (Ayurveda) |
| Affiliation |
Bharati Vidyapeeth Deemed to be University, College of Ayurveda and Hospital, Pune |
| Address |
Raykarnagar, Dhayari
Dhanakawadi, Pune 411043
Pune
MAHARASHTRA
411041
India |
| Phone |
09766895511 |
| Fax |
|
| Email |
vdmahesh@ymail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed to be University College of Ayurved and Hospital Pune |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [NIL] |
|
|
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 Bhujbal Mahesh Dattatray |
Bharati Vidyapeeth deemed to be University, College of Ayurved and hospital Pune 43 |
OPD no. 4, Department of Kayachikitsa, Bharati Vidyapeeth deemed to be University, College of Ayurved and hospital, Dhanakavadi, Katraj, Pune 43
Pune
MAHARASHTRA |
09766895511
vdmahesh@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth deemed to be University college of ayurveda ethics comitee (BVDUCOA-EC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
1. Only Female participants
2. Age group - 18-40 years
3. Subjects exposing to heat, sunny environment |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: raktachandanadi skin serum, Reference: 2. Shashtri P. Sharangdhar Samhita with Deepika Commentry by Aadhmalla, Chaukhambha Orientalia, Varanasi.Sixth Edition 2005. Uttar Khand, Lepavidhi – 11/1, Page 357. , Route: Topical, Dosage Form: Taila, Dose: 4(drops), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Raktachandanadi lepa will be converted into serum by using natural substances and it will be used topically. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Only Female participants
2. Age group - 18-40 years
3. Subjects exposing to open to sky sunny environment in any season for not less than 30 min per day. |
|
| ExclusionCriteria |
| Details |
1. Participant using another external application or internal medication for skin complexion enhancement. e. g. marketed creams or serums for skin beautification.
2. Individual suffering from inflammatory pigmentation, melasma.
3. Patient suffering from malignant melanoma.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in Radiance / Glow and reduction in tanning of skin. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Protection from sunlight and harmful infrared rays. |
30 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/09/2025 |
| 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 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
|
Study of human skin represents an
important area of research and development in dermatology, toxicology,
pharmacology and cosmetology. In ayurveda
samhita, there are many external yoga (formulations) which are used for skin.
Most of them are in the form of Lepa kalpana (external application). For
enhancement of skin complexion, there are number of lepa described in
various samhita text. In past time, it was feasible for
people to take time and apply lepa. All the lepa vidhi. i. e. rules
of external application were followed by people in past. But nowadays, due to lack
of time, it’s very difficult for people to apply lepa chikitsa
(treatment). Now a days various kantivardhan yoga i.e. skin complexion
enhancement formulations are used in market in various dosage forms. The term ‘kanti’
stands for skin radiance, glow, brightness, luster. kantivardhan means
enhancement in radiance or de-tanning. In ayurvedic literature, different yogas
are advised to show kantivardhan action. Amongst those yogas, raktachandanadi
lepa is suggested as mukhakantikar lepa in sharangdhar samhita. in the present study, raktachandanadi
skin serum (RCSS) will
be studied for the clinical evaluation of kantivardhan action (increase in
radiance and de-tanning effect) in the emulsion serum form.
|