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CTRI Number  CTRI/2021/09/036678 [Registered on: 21/09/2021] Trial Registered Prospectively
Last Modified On: 20/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of Nasal drop and lepa in muhaase (acne) 
Scientific Title of Study   Evaluation of Nasya karma and sthanik lepa with jatiphaladi yoga in yuvanpidika 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr krishna kumar sharma  
Designation  Professor  
Affiliation  Rishikul campus Uttarakhand Ayurved university  
Address  Department of Panchkarma, rishikul campus Haridwar Uttarakhand Ayurved University Kripayanam Gandhi road kankhal opposite telephone exchange Haridwar

Hardwar
UTTARANCHAL
249401
India 
Phone  9758264264  
Fax    
Email  Kripayanam@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr krishna kumar sharma  
Designation  Professor  
Affiliation  Rishikul campus Uttarakhand Ayurved university  
Address  Department of Panchkarma, rishikul campus Haridwar Uttarakhand Ayurved University Kripayanam Gandhi road kankhal opposite telephone exchange Haridwar


UTTARANCHAL
249401
India 
Phone  9758264264  
Fax    
Email  Kripayanam@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Himani Yadav 
Designation  MD scholar  
Affiliation  Rishikul campus Uttarakhand ayurved university  
Address  Department of Panchkarma, rishikul campus Haridwar Uttarakhand Ayurved university

Hardwar
UTTARANCHAL
249401
India 
Phone  8295877500  
Fax    
Email  Himaniyadav800@gmail.com  
 
Source of Monetary or Material Support  
Rishikul Campus UAU Haridwar 
 
Primary Sponsor  
Name  Uttarakhand Ayurved University  
Address  Uttarakhand Ayurved University Harrawala Dehradun 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Himani yadav  OPD and IPD of rishikul campus haridwar   Department of Panchkarama Room no. 20
Hardwar
UTTARANCHAL 		 8295877500

Himaniyadav800@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: YUVANAPIDAKA (MUKHADUSHIKA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Astangahridya uttartantra 32/3, Procedure details: sthanika abhayanga will be done with jatiphaladi ghrita followed by sthanika swedana. After that nasya will be given in 3 sittings of 7 days each with Jatiphaladi Ghrita at the interval of 3 days in between each sitting. dumpana will be given after nasya as paschyata karma)
(1) Medicine Name: Jatiphaladi ghrita, Reference: Yogaratanakar kshudra chikitsa pathbheda/2, Route: Nasal, Dosage Form: Ghrita, Dose: 8(drops), Frequency: od, Duration: 7 Days
2Intervention ArmProcedure-lepaH (viShopakramaH), लेपः (विषोपक्रमः) (Procedure Reference: Yogratanakra kshudrachikitsa pathbheda/1, Procedure details: face will be cleaned with fresh water after that jatiphaladi lepa (ointment) will be applied on affected area once in a day for 30 days)
(1) Medicine Name: jatiphaladi lepa (ointment), Reference: YogratanakaraKshudrachiktsa pathbheda/2, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 1(NA), Frequency: od, Duration: 30 Days
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1-Patient having sign and symptoms of Yuvanpidika(acne vulgaris)
2-patient of age between 15-30 yrs
3-patient of either sex will be taken
4-patient fit for nasya karma and sthanika lepa
5-patient is willing to take the treatment 
 
ExclusionCriteria 
Details  1-patient not fit for nasya karma
2-any other clinically diagnosed skin disease
3-patient with acne on regions other than face
4-uncontrolled diabetes mellitus
5-hypertension & other life threatening and complicated diseases
6-pregnant women 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Marked improvement: 76-100%
Moderate improvement: 51-75%
Mild improvement: 26-50%
no improvement: 0- 25%
 		 0, 10th, 20th and 30th
 
 
Secondary Outcome  
Outcome  TimePoints 
exacerbation in sign and symptoms  30 days 
 
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   N/A 
Date of First Enrollment (India)   01/10/2021 
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="0"
Months="10"
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 vulgaris is a common chronic inflammatory disease of pilosebaceous unit in adolescence characterized by comedones, papules, nodules, cyst and often scars on face .Mostly occur in teenagers and young adults due to overactivity of oily glands in the skin.In presesnt study two groups are taken. First group contains 20 patients and given Nasya of jatiphaladi yoga. second group contains 20 patients and given Lepa of Jatiphaladi yoga. 
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