| CTRI Number |
CTRI/2023/07/055589 [Registered on: 24/07/2023] Trial Registered Prospectively |
| Last Modified On: |
20/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of avoiding nidan In Acne |
|
Scientific Title of Study
|
Evaluation Of The Effect Of Nidana Parivarjana In Yuvan Pidika |
| 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 Sanjay Kumar Singh |
| Designation |
Professor |
| Affiliation |
Rishikul Campus UAU |
| Address |
OPD no 21 and IPD of Rog Nidan evum vikriti vigyan department Rishikul campus Uttarakhand Ayurved University haridwar Uttaranchal India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
7060754892 |
| Fax |
|
| Email |
drsanjaysingh1970@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Kumar Singh |
| Designation |
Professor |
| Affiliation |
Rishikul Campus UAU |
| Address |
OPD no 21 and IPD of Rog Nidan evum vikriti vigyan department Rishikul campus Uttarakhand Ayurved University haridwar Uttaranchal India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
7060754892 |
| Fax |
|
| Email |
drsanjaysingh1970@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanya Chadha |
| Designation |
PG Scholar |
| Affiliation |
Rishikul Campus UAU |
| Address |
OPD no 21 and IPD of Rog Nidan evum vikriti vigyan department Rishikul campus Uttarakhand Ayurved University haridwar Uttaranchal India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8218512867 |
| Fax |
|
| Email |
tanyachadha14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul campus, UAU, Haridwar |
|
|
Primary Sponsor
|
| Name |
Rishikul Campus, UAU |
| Address |
Rishikul Campus, UAU, Hardwar |
| 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 |
| Dr Tanya Chadha |
Rishikul Campus UAU Haridwar |
OPD no 21 and IPD of Rog Nidan Evum Vikriti Vigyan department Rishikul Rishikul Campus UAU Haridwar
Hardwar
UTTARANCHAL |
8218512867
tanyachadha14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Uttarakhand Ayurved University Rishikul Campus Haridware |
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 | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: nimba vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -koushna jal), Additional Information: - | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:nidan privarjana, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patient with classical clinical symptoms of Yuvan Pidika
Patient of age group 16 to 30 years
|
|
| ExclusionCriteria |
| Details |
Patient having age below 16 and above 30
Pidika due to any other systemic disease like Prameha
Patient with other skin disorders like psoriasis leprosy atopic dermatitis etc
Patient with diabetes
Patient suffering from any chronic disorders/systemic disorders.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the aetiopathogenesis of Yuvan Pidika |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Nidana parivarjana & Nimba Vati in management of Yuvan Pidika |
6 weeks |
|
|
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 1 |
|
Date of First Enrollment (India)
|
07/08/2023 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study will be performed to evaluate the effect of nidana parivarjana in yuvan pidika. Patients fulfilling the diagnostic criteria of yuvan pidika will be taken in the study. The status of the patient will be recorded on the day of enrollment on the basis of parameters taken in the study and response of nidan parivarjana will be recorded after the completion of study. This study will assess the role of nidana parivarjana in the management of yuvan pidika. |