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CTRI Number  CTRI/2023/11/060205 [Registered on: 23/11/2023] Trial Registered Prospectively
Last Modified On: 15/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Markavyuktakshir Nasya for vyanga(melasma) patients for 15 days  
Scientific Title of Study   An exploratory clinical study to evaluate the efficacy of Markavyukta ksheer Nasya in the management of vyanga 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shubhangi vishwanath maske 
Designation  PG scholer  
Affiliation  Pdeas College of ayurved and research centre nigadi pradhikaran pune  
Address  College of ayurved and research centre 3rd floor panchakarma department near stairs opposite to auditorium, sector 27 nigadi pradhikaran pune 411044

Pune
MAHARASHTRA
411044
India 
Phone  8390388566  
Fax    
Email  shubhmaske26@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr pournima M daware- rikibe 
Designation  Associate professor 
Affiliation  Pdeas College of ayurved and research centre nigadi pradhikaran pune  
Address  College of ayurved and research centre,3rd floor,panchakarma department ,sector 27 nigadi pradhikaran pune 411044


MAHARASHTRA
411044
India 
Phone  9762561699  
Fax    
Email  Rikibepournima@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shubhangi maske 
Designation  PG scholer  
Affiliation  Pdeas College of ayurved and research centre nigadi pradhikaran pune  
Address  College of ayurved and research centre,3rd floor, panchakarma department opposite to auditorium, sector 27 nigadi pradhikaran pune 411044

Pune
MAHARASHTRA
411044
India 
Phone  8390388566  
Fax    
Email  shubhmaske26@gmail.com  
 
Source of Monetary or Material Support  
PDEAS college of ayurved and research centre Nigadi pune 
 
Primary Sponsor  
Name  PDEAS college of ayurved and research centre Nigadi pune 
Address  PDEAS college of ayurved and research centre Nigadi pune,3rd floor panchakrma department,sector 25 nigadi,pradhikaran pune 
Type of Sponsor  Private 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 
Dr Shubhangi Vishwanath Maske  Ayurved Rugnalaya and Sterling Multi Speciality Hospital Nigadi Pune  ARSMH 1ST floor panchakarma department room number 216
Pune
MAHARASHTRA 		 8390388566

shubhmaske26@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PDEAS COLLEGE OF AYURVEDIC RESEARCH AKURDI PUNE -Institutional Ethics Committee-I for Human Reasearch  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L578||Other skin changes due to chronicexposure to nonionizing radiation. Ayurveda Condition: VYANGAH, (2) ICD-10 Condition:L55-L59||Radiation-related disorders of the skin and subcutaneous tissue. Ayurveda Condition: Patients having tanu niruj mandal on face chicks chin forehead ,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Ashtang hrudaya sutrasthan 20/4, Procedure details: After sthanik abhyang & swedan then 6 bindus Medicine will be poured in both the nostrils by closing another nostril as per the referance given)
(1) Medicine Name: Markav yukta kshir, Reference: Ashtang hrudaya uttartantra 32/32, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 6(drops), Frequency: od, Duration: 15 Days
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1.Patients showing classical signs and symptoms of vyanga like tanu, niruja, shyava mandal on face.
2. Patients of age between 25 to 55 years irrespective of gender, religion and economic status
 
 
ExclusionCriteria 
Details  1. Vyanga caused due to any known systemic disease like Addison’s disease, Cushing’s syndrome.
2. Vyanga caused since birth like Nevus of Ota
3. Vyanga along with kushta roga
4. Hyper pigmentation caused by known case of tumour like malignant melanoma
5. Pregnant and lactating women
6. Patient’s anarha for nasya karma
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To Evaluate efficacy of markavyuktakshir nasya in management of vyanga for 15 days  3 follow ups will be taken on 7th,15th and 21th day and the treatment will be given for 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
To observe the adverse effect if any for 15 days  15 days study with 3 folow ups 7th, 15th and 21th day 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   27/11/2023 
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="0"
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   Nowadays beauty has its own importance.Vyanga is nothing but the discolouration of skin somehow like patches of different colours on face  which is explained by vagbhata in kshudrarogas. Under its treatment vagbhat has mentioned markavyuktakshir nasya for managing vyanga disease. The above treatment will be given to patients for 15 days and results will be noted. mainly the color changes in complexion of skin will be noted. 
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