CTRI Number |
CTRI/2020/11/028881 [Registered on: 04/11/2020] Trial Registered Prospectively |
Last Modified On: |
03/11/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Study of effect of siddharthakadi lepa and vamankarma in volunteers having pimples |
Scientific Title of Study
|
A comparative phase II clinical study to evaluate the efficacy of Siddharthakadi Lepa and Vaman followed by Siddharthakadi Lepa in Yuvanpidika with special reference to acne vulgaris |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Shraddha Dnyandev Patil |
Designation |
PG student |
Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik |
Address |
OPD no 24 Department of Panchakarma
Nashik MAHARASHTRA 422003 India |
Phone |
9970620994 |
Fax |
|
Email |
shraddhupatil32@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Savita Kulkarni |
Designation |
Asso Professor and Guide |
Affiliation |
Ayurved Mahavidyalaya Nashik |
Address |
OPD no 24 Department of Panchakarma
Nashik MAHARASHTRA 422003 India |
Phone |
9423081487 |
Fax |
|
Email |
drsavita.k07@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Savita Kulkarni |
Designation |
Asso Professor and Guide |
Affiliation |
Ayurved Mahavidyalaya Nashik |
Address |
OPD no 24 Department of Panchakarma
MAHARASHTRA 422003 India |
Phone |
9423081487 |
Fax |
|
Email |
drsavita.k07@gmail.com |
|
Source of Monetary or Material Support
|
Arogyashala Rugnalaya Ganeshwadi Panchavati Nashik |
|
Primary Sponsor
|
Name |
Dr Shraddha Dnyandev Patil |
Address |
Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik |
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 Shraddha Dnyandev Patil |
Arogyashala Rugnalaya Nashik |
OPD no 24 Panchakarma OPD Nashik MAHARASHTRA |
9970620994
shraddhupatil32@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ayurved Seva Sangh ayurveda Mahavidyalaya Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Having Acne Vulgaris |
Patients |
(1) ICD-10 Condition: L70||Acne, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Siddharthakadi lepa |
5 gms once a day topically for 21 days after Vamankarma |
Comparator Agent |
Siddharthakadi lepa |
5 gms once a days topically for 21 days |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
30.00 Year(s) |
Gender |
Both |
Details |
Diagnosed subjects of Yuvanpidika with classical signs and symptoms such as Kandu Daha Ruja Srava Vaivarnya
Subjects fit for Vamankarma |
|
ExclusionCriteria |
Details |
Avoid other Skin Disorder
Endocrine disorders
Genetic disorders
patient suffering from other skin diseases and systemic diseases female patients of hormonal
disorders like Hirsutism Hypogonadism |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Reduction in signs and symptoms of acne vulgaris |
30 Days |
|
Secondary Outcome
|
Outcome |
TimePoints |
Reduction of discoloration over the affected area |
30 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/ Phase 3 |
Date of First Enrollment (India)
|
23/11/2020 |
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 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
|
Acne appears on the skin as blackheads white heads pimples pustules and cysts Some factors that cause acne are some food habits diet stress hereditary drugs occupation cosmetics Acne vulgaris is a most common burning issue in the Adolscents age group The incidence of the acne vulgaris is rising tremendously now a days Face is the mirror of the individual personality and any least mark can result into a larger impact on the individuals Everyone wants to have beautiful and charming skin Change in the lifestyle and diet pattern environmental changes has increases The incidence of these diseases From the ancient time Ayurveda is known for serving the society by cure and prevention and this concept is exactly applicable on the cure and prevention of the Yuvanpidika There are number of preventives curative aspect lepa medicinal drugs and preparations described in the Ayurveda having wonderful effect on these diseases Though several Ayurveda texts such as Sushruta Samhita Ashtanga Hrudaya etc have elaborated the pathophysiology and treatment of acne the available references are scattered Thus there is need of in depth review and compilation of Ayurvedic texts and literatures So this study is useful in treating Yuvanpidika So i select the topic of yuvanpidika applying lepa externally on face 5 gm of Siddharthakadi Churna into sufficient quantity of water and vaman karma is internally |