| CTRI Number |
CTRI/2023/08/056768 [Registered on: 22/08/2023] Trial Registered Prospectively |
| Last Modified On: |
12/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study on acne vulgaris (acne) |
|
Scientific Title of Study
|
An observational study of daihik prakriti wsr to yuvan pidika (Acne vulgaris) |
| 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 Jyoti Kumari |
| Designation |
MD Scholar |
| Affiliation |
State Ayurvedic College Hospital Lucknow Uttar Pradesh 226004 |
| Address |
Department Of Kriya Sharir State Ayurvedic College Hospital Lucknow Uttar Pradesh
226004
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
7060161537 |
| Fax |
|
| Email |
jyotishekhawat29477@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh Kumar |
| Designation |
MD Lecturer PG Department Of Kriya Sharir |
| Affiliation |
State Ayurvedic College Hospital Lucknow Uttar Pradesh 226004 |
| Address |
Department Of Kriya Sharir State Ayurvedic College Hospital Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9598999121 |
| Fax |
|
| Email |
sureshksagar77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suresh Kumar |
| Designation |
MD Lecturer PG Department Of Kriya Sharir |
| Affiliation |
State Ayurvedic College Hospital Lucknow Uttar Pradesh 226004 |
| Address |
Department Of Kriya Sharir State Ayurvedic College Hospital Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9598999121 |
| Fax |
|
| Email |
sureshksagar77@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Ayurvedic College and Hospital Tulsidas Marg Tudiyaganj Lucknow 226004 |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic College and Hospital Lucknow |
| Address |
State Ayurvedic College and Hospital Tuksidas Marg Lucknow Uttar Pradesh 226004 |
| 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 Suresh Kumar |
State Ayurvedic College and Hospital Lucknow |
OPD No 9 Department Of Kaya Chikitsa State Ayurvedic College and Hospital Tulsidas Marg Tudiyaganj Lucknow
Lucknow
UTTAR PRADESH |
9598999121
sureshksagar77@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE |
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 14 to 30 years of age
The diagnosis is made on the basis of sign and symptoms of Yuvanapidika as per Ayurvedic text |
|
| ExclusionCriteria |
| Details |
Patients suffering from any communicable infectious disease
Age below 14 years and above 30 years
Complicated acne associated with infection |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evolve the relation between Yuvanpidika with Daihik prakriti |
Three to six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the importance of role of daihik prakriti
Literature review of acne vulgaris & daihik prakrirti |
Three to six months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
08/09/2023 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study is entitled as - An observational study of Daihik Prakriti with special reference to Yuvanpidika (Acne Vulgaris) Objective of the study - The present will be undertaken with following objectives: For the purpose of aim, all available Ayurvedic, modern literature, published research papers, articles will be reviewed and the relevant contents will be collected, classified, observed, discussed concluded and result will be prepared accordingly. Type Of Study - Observational study Duration Of Period - 3-6 months Criteria for selection of patients - Patient having symptoms of Yuvanpidika like Pidika associated with Ruja, Ghana, Medogarbha, Yuvamukha will be selected. Inclusion Criteria - Patients between 14 years to 30 years The diagnosis is made on the basis of sign and symptoms of Yuvanpidika as per Ayurvedic text Exclusion Criteria - Patients suffering from any communicable infectious disease Age below 14 years and above 30 years Complicated acne associated with infection
|