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CTRI Number  CTRI/2020/04/024755 [Registered on: 21/04/2020] Trial Registered Prospectively
Last Modified On: 10/04/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To find out and compare the effectiveness of Kanaka Taila and Kumkumadi Taila nasya in the treatment of Vyanga (a skin disorder ) 
Scientific Title of Study   A randomised comparative clinical trail to evaluate the efficacy of Kanaka Tail nasya with Kumkumadi Tail nasya in Vyanga 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sireesha Satyanarayana Popuri 
Designation  PG Final Year 
Affiliation  PDEAs College of Ayurveda And Research Centre Akurdi 
Address  PDEAs College of Ayurveda and Research Centre Nigdi Ayurved Rugnalaya and Sterling Multispeciality Hospital Sector no 27 Pradhikaran Nigdi Pune Department of Panchkarma OPD no 215 First floor

Pune
MAHARASHTRA
411044
India 
Phone  9640124214  
Fax    
Email  sirivaidya1405@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Varsha Sane 
Designation  HOD Panchkarma Department 
Affiliation  PDEAs College of Ayurveda And Research Centre Akurdi 
Address  PDEAs College of Ayurveda and Research Centre Nigdi Ayurved Rugnalaya and Sterling Multispeciality Hospital Sector no 27 Pradhikaran Nigdi Pune Department of Panchkarma OPD no 215 First floor

Pune
MAHARASHTRA
411044
India 
Phone  9923800634  
Fax    
Email  varsha.kale80@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sireesha Satyanarayana Popuri 
Designation  PG Final Year 
Affiliation  PDEAs College of Ayurveda And Research Centre Akurdi 
Address  PDEAs College of Ayurveda and Research Centre Nigdi Ayurved Rugnalaya and Sterling Multispeciality Hospital Sector no 27 Pradhikaran Nigdi Pune Department of Panchkarma OPD no 215 First floor

Pune
MAHARASHTRA
411044
India 
Phone  9640124214  
Fax    
Email  sirivaidya1405@gmail.com  
 
Source of Monetary or Material Support  
PDEAs College of Ayurveda and Research Centre Sector no 25 Pradhikaran Nigdi Pune 411044 
 
Primary Sponsor  
Name  PDEAs College of Ayurveda and Research Centre Akurdi 
Address  PDEAs College of Ayurveda and Research Center Sector no 25 Pradhikaran Nigdi Pune 411044 
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 
Sireesha Satyanarayana Popuri  Ayurved Rugnalaya and Sterling Multispeciality Hospital   Vithal Rakhumai Road Sector 27 Nigdi Pradhikaran Pune Name of OPD Panchakarma OPD Number 215 First Floor
Pune
MAHARASHTRA 		 9640124214

sirivaidya1405@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L988||Other specified disorders of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kanaka Tail Nasya  Group A of 34 Patients having Vyanga will be administered with Kanaka Tail Nasya 6 Drops in Each Nostril for 7 Days 
Comparator Agent  Kumkumadi Tail Nasya  Group B of 34 Patients Having Vyanga will be Administered with Kumkumadi tail nasya 6 drops in each nostril for 7 days and final result will be compared with group A results 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having classical symptoms of vyanga like tanu niruja shyava mandal on face of patient arha for nasya 
 
ExclusionCriteria 
Details  Known case of systemic diseases vyanga either congenital or along with kushta known case of inflammatory disease of nose 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of kanaka tail nasya and kumkumadi tail nasya in the management of vyanga on the basis of subjective and objective parameters within 15 days  Daily assessment will be done for 7 days in the duration of nasya treatment and final assessment follow up will be done on 15th day with the window period of 5 days 
 
Secondary Outcome  
Outcome  TimePoints 
To study the adverse effects if any  For 7 days of nasya administration 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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)   24/04/2020 
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   NONE YET 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Skin plays a major role in the physical beauty and personality of an individual and its importance is increasing nowadays as skin reflects healthy state of psychology and physique. The complexion reflects the beauty of a person which includes colour, texture and appearance of the skin. All the aspects of the complexion are affected in Vyanga disease

औषधमौषधसिद्धोवास्नेहोनासिकाभ्यांदीयतेइतिनस्यम् | सु .चि .40/21

Panchakarma is a natural, specific, unique and holistic health improving series of therapeutic treatments which cleanses body deep tissue toxins and opens subtle channels and brings life enhancing energy. Administration of the drug or medicated liquid like sneha, swarasa through the nostrils is known as nasya. Nasya is one among panchakarma indicated in kshudra roga as it eliminates dosha to treat the disease.

शमनंनीलिकाव्यङ्गकेशदोषाक्षिराजिषु ||5

Shaman nasya is indicated to treat vyanga . Nasya relieves excessive pitta and there by helps in improving complexion.

In India many cosmetic products are available in the market for improvement of the complexion. These products are expensive and the results are not up to the mark. On the contrary, Ayurveda provides safe, effective and economically cheaper methods of treatment for skin disorders like vyanga.

“Beautiful women and intellectual men are always praised”.

Vyanga is a kshudra rog having simple aetiology and symptoms; still there is a definite need for treatment as a disease and of cosmetic value too. The disease vyanga can be correlated with hyper pigmentation with special reference to melasma. In melasma patches of hyperpigmentation are seen on cheeks, nose, forehead and chin.

It is very common chronic disorder usually seen in women of child bearing age. It was estimated that 12.3% to 19.4% of the world population is suffering with this problem.

Currently available cosmetics in the market harm the skin and also cause irreparable damage to the skin. There is enough description regarding maintenance of the natural beauty and treatment of the skin disorders in classical texts of ayurveda. There was no need to separate cosmetology as a special branch in that period of time. Now it is time to highlight Ayurveda in the world of cosmetics with its unique aspects. Hence the present study intended to know effect of kanaka tail nasya compared with kumkumadi tail nasya in vyanga.

 
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