| CTRI Number |
CTRI/2022/06/043157 [Registered on: 10/06/2022] Trial Registered Prospectively |
| Last Modified On: |
28/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [cosmaceutical] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Varnya karma of Padmaka ( Prunus cerasoides DON. in individuals with skin phototype 3 to 5 on Fitzpatrick scale |
|
Scientific Title of Study
|
Assessment of Varnya karma of Padmaka ( Prunus cerasoides DON.) in individuals with skin phototype 3 to 5 on Fitzpatrick scale- A randomized clinical study |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shavnam Chaudhary |
| Designation |
PG Scholar |
| Affiliation |
All India Institue of Ayurveda |
| Address |
Department of Dravyaguna, All India Institute of Ayurveda Mathura Road Gautampuri Sarita Vihar Delhi 110076
South
DELHI
110076
India |
| Phone |
8988856627 |
| Fax |
|
| Email |
shavnamchoudhary64@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Proff Meena Deogade |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Dravyaguna All India Institute of Ayurveda Mathura Road Gautampuri Sarita Vihar Delhi 110076
South
DELHI
110076
India |
| Phone |
9404049302 |
| Fax |
|
| Email |
drmmeena@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Proff Meena Deogade |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Dravyaguna All India Institute of Ayurveda Mathura Road Gautampuri Sarita Vihar Delhi 110076
South
DELHI
110076
India |
| Phone |
9404049302 |
| Fax |
|
| Email |
drmmeena@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda(AIIA) |
|
|
Primary Sponsor
|
| Name |
All india institute of ayurveda |
| Address |
All India Institute of Ayurveda(AIIA) Mathura Road, Gautampuri Sarita Vihar, Delhi-110076 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shavnam Chaudhary |
Deptt. of Dravyaguna, C-block, room no.-219, All India Institute of Ayurveda(AIIA) |
All India Institute of Ayurveda(AIIA) Mathura Road, Gautampuri Sarita Vihar,
South
DELHI |
8988856627
shavnamchoudhary64@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteers with skin phototype between 3 to 5 on Fitzpatrick scale |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Padmak, Reference: Charak samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 600(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Padmak, Reference: charak samhita, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
a) Willing to participate in the study
b) Healthy Volunteers without any comorbidities
c) Skin Phenotype 3 to 5 on Fitzpatrik scale |
|
| ExclusionCriteria |
| Details |
a) Volunteers having any present or past history of skin disease.
b) Not willing to participate in the study
c) Any fungal, bacterial or viral infections.
d) Pregnant or lactating woman and woman on contraceptive pills.
f) Auto immune skin diseases, chronic systemic diseases.
e) Individuals having permanent scars on face. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in the scores on Fitzpatrick scale in accordance with older Von
Luschan scale ( by 3 unit) |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in dryness, oiliness, tanning and dullness of skin. |
2 months |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
20/06/2022 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is the natural desire of the mankind to have a healthy and glowing skin, it boosts up their confidence also. Extreme environmental conditions and pollution deteriorates the natural complexion and health of the skin. Market available beauty products have many side effects so that there is need to introduce more ayurvedic drugs with less or no side effects to restore skin health and complexion. Varnya drugs are meant for restoring natural color and complexion of the body by improving overall health of the skin. Padmaka is one of the drugs of Varnya dashemani mentioned by Acharya Charaka and is very less explored by researchers, so the present study is to revalidate the Varnya karma of Padmaka. |