| CTRI Number |
CTRI/2021/04/032883 [Registered on: 16/04/2021] Trial Registered Prospectively |
| Last Modified On: |
21/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of Skin and Role of Ayurveda medication in Yuvanpidaka. |
|
Scientific Title of Study
|
A Physiological Study of Twak Sharir with special reference to Role of Kusthadi Lepa and Jalaukavacharana along with Manjishtha Churna in Yuvanpidaka. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nilkanth Upadhyaya |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
Room no.- 218, P.G. Department of Sharir Kriya, Madhav Vilas Palace, Jorawar Singh Gate, Amer Road
JAIPUR
Jaipur
RAJASTHAN
302002
India |
| Phone |
8619188370 |
| Fax |
|
| Email |
nupadhyaya19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chhaju Ram Yadav |
| Designation |
Asso. Prof. & HOD |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
P.G. Department of Sharir Kriya, Madhav Vilas Palace, Jorawar Singh Gate, Amer Road
JAIPUR
Madhav Vilas Palace, Jorawar Singh Gate, Amer Road
JAIPUR - 302002 (RAJASTHAN) INDIA
Jaipur
RAJASTHAN
302002
India |
| Phone |
9460866101 |
| Fax |
|
| Email |
dr.yadavcr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nilkanth Upadhyaya |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
Room no.- 218, P.G. Department of Sharir Kriya, Madhav Vilas Palace, Jorawar Singh Gate, Amer Road
JAIPUR
Jaipur
RAJASTHAN
302002
India |
| Phone |
8619188370 |
| Fax |
|
| Email |
nupadhyaya19@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Jaipur, India |
|
|
Primary Sponsor
|
| Name |
National institute of Ayurveda |
| Address |
Madhav Vilas Palace, Jorawar Singh Gate, Amer Road
JAIPUR - 302002 (RAJASTHAN) INDIA |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Nilkanth Upadhyaya |
NIA Hospital |
OPD no. 3, Sharir Kriya Department,
NIA Hospital
Madhav Vilas Palace, Jorawar Singh Gate-302002
Jaipur
RAJASTHAN |
8619188370
nupadhyaya19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee, National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L700||Acne vulgaris. Ayurveda Condition: YUVANAPIDAKAÂ (MUKHADUSHIKA), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Manjishtha Churna and Kusthadi Lepa |
Manjistha Churna: dose-3 gm with lukewarm water, orally, twice a day, for 30 days
Kusthadi Lepa: use in paste form, local application, externally use, once a day for 30 days |
| Comparator Agent |
Manjistha Churna and Jalaukavacharana |
Manjistha churna: dose- 3 gm with lukewarm water, orally, twice a day for 30 days
Jalaukavacharana: once in a week for 30 days |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient willing to undergo trial and ready to give informed
consent(In case of minor patients, i.e. age<18years, consent
will be given by Parents/Guardian/Attendant)
2. Patients are either sex.
3. Patient in the age group of 16-40 years.
4. Patient with sign and symptoms of Yuvanpidaka .
5. Patient fit for Jalukavacharana. |
|
| ExclusionCriteria |
| Details |
1. Known case of any Acute / chronic skin diseases like
Psoriasis, Vitiligo, Dermatitis etc.
2. Known case of any genetic skin disorder, chronic systemic
diseases, Sexually Transmitted Disease, Diabetes Mellitus,
Hypertension, any blood disorders or any organ failure. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Global Acne Grading System. |
At Baseline(0th day),15th, and 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relief in classical sign and symptoms(Kandu, Ruja, Daha,
Shrava, Snigdhata, Vaivarnya),
Increase in Varnyaprasadan, Prabha vriddhi.
|
will be done after 15 days of completion of treatment in all group. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/07/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The skin covers the external surface of the body and is the largest
organ in both surface area and weight. It is metabolically active
with vital function protection and maintaining homeostasis of the
body. Acne is one type of skin related problems. Acne is the major problems at the puberty age. According to the
Global Burden of Disease (GBD) study, acne vulgaris affects
~85% of young adults aged 12–25 years and represents the top
three most prevalent skin conditions in general populations.In Conventional Medical treatment there is no satisfactory results
and has different adverse effects on the body. There are many texts mentioning medication for Yuvanpidaka
which need to be tested and validated scientifically. So, it is the
need of the hour to study the physiology of Twak Sharir, to test and
validate scientifically, to role of Kusthadi Lepa and
Jalaukavacharana along with Manjishtha Churna in Yuvanpidaka and After reviewing the literature and keeping in mind the DoshaDushya of Yuvanpidaka, Manjishtha churna from Charak
Samhita, Kusthadi Lepa and Jalaukavacharana from Sushruta
Samhita has been chosen for the study as these drugs possess
above mentioned properties required for the management of
Yuvanpidaka.
|