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CTRI Number  CTRI/2024/02/062768 [Registered on: 16/02/2024] Trial Registered Prospectively
Last Modified On: 04/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Evaluation of External Application of Varnyakar Lepa and Leech therapy in Vyanga(Melasma) 
Scientific Title of Study   To evaluate the role of Jalukavacharan with Varnyakar lepa in management of Vyanga(Melasma) 
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 Pratiksha Dundappa Talawar  
Designation  Professor  
Affiliation  Dr.J.J.Magdum Ayurved Medical College Jaysingpur 
Address  Agar bhag Shirol wadi road Jaysingpur Tal Shirol District Kolhapur

Kolhapur
MAHARASHTRA
416101
India 
Phone  8975166148  
Fax    
Email  dr.pratiksha2009@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pratiksha Dundappa Talawar  
Designation  Professor  
Affiliation  Dr.J.J.Magdum Ayurved Medical College Jaysingpur 
Address  Agar bhag Shirol wadi road Jaysingpur Tal Shirol District Kolhapur

Kolhapur
MAHARASHTRA
416101
India 
Phone  8975166148  
Fax    
Email  dr.pratiksha2009@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pratiksha Dundappa Talawar  
Designation  Professor  
Affiliation  Dr.J.J.Magdum Ayurved Medical College Jaysingpur 
Address  Agar bhag Shirol wadi road Jaysingpur Tal Shirol District Kolhapur

Kolhapur
MAHARASHTRA
416101
India 
Phone  8975166148  
Fax    
Email  dr.pratiksha2009@gmail.com  
 
Source of Monetary or Material Support  
Dr.J.J.Magadum Ayurved Medical College Jaysingpur  
 
Primary Sponsor  
Name  DrPratiksha Dundappa Talawar 
Address  Dr.J.J.Magadum Ayurved Medical College Agar bhag Shirol wadi road Jaysingpur Tal Shirol District Kolhapur  
Type of Sponsor  Government funding agency 
 
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 
DrPratiksha Dundappa Talawar  Dr.J.J.Magdum Ayurved Medical college Jaysingpur  Kayachikitsa OPD &IPD of Hospital Dr.Dr.J.J.Magdum Ayurved Medical college Agar bhag Shirolwadi Road Jaysingpur 416101
Kolhapur
MAHARASHTRA 
8975166148

dr.pratiksha2009@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC of Dr.J J Magdum Ayurved Medical college Jaysingpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L814||Other melanin hyperpigmentation. Ayurveda Condition: VYANGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-jalaukAvacaraNam, जलौकावचरणम् (Procedure Reference: Asthang hridayam Uttar Tantra 32/15, Procedure details: Jalaukawacharan will be done two times at first day & fifteenth day.)
2Intervention ArmDrugClassical(1) Medicine Name: Varnyakara Lepa, Reference: Charak sutrasthan 4/8, Route: Topical, Dosage Form: Lepa Churna, Dose: 25(g), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 2 Months, Reference: No, Route: NA, Dosage Form: Lepa Churna, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patients with signs & symptoms of Vyanga.
2 Signs & symptoms of Melasma. 
 
ExclusionCriteria 
Details  1 Known case of any active skin malignancy
2 Pregnant woman
3 Patients suffering from all major systemic diseases IHD HIV Carcinoma
4 Patients having contagious infectious disease such as active tuberculosis Hepatitis B and C
5 Cases of burn & any skin allergy
6 Any lesion of other skin disease  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Evaluate effect of Jalaukawacharan & Varnykar lepa in Vyanga (melasma) on the basis if assessment criteria of colour of melasma size of lesion & MASI score.  Follow up- 1st,15th, 30th ,45 th ,60 th day  
 
Secondary Outcome  
Outcome  TimePoints 
To observe the recurrence of melasma  After leech application- 30th,45th, 60th day 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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)   26/02/2024 
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  
        In Ayurveda skin diseases are included under the headings of Kshudrarogas and Kushta. Sushrutacharya was the first Acharya who had given detailed
describtion of Vyang under the chapter of “Kshudraroga”.The clinical feature of Vyanga can be correlated with Melasma which is one of the common hyper pigmented disorders. The melasma is harmless condition, progression can be cosmetically and psychologically overwhelming.
         Treating Melasma in modern science has become a problem and safe drugs for long term therapy are not available in modern medicine.There are treatments available but they may not have impact on malasma or clear it up completely,so its important to know what you can do to help minimize the appearance of dark spots & prevent them from getting worse.Topical steroids have been described in the management of facial melanosis  and these steroids have adverse effect.
According to Acharya Sushrut, Krodh and Shok are causative factors for development of Vyanga as these psychological factors vitiate Pitta and Vata dosha leads to develop Shyava varna mandala on face. Bhrajak pitta is important in production of varna in Avabhasini twacha (one of layer of skin).Vitiation of Pitta dosha in Vyanga, leads to Rakta dusthi producing vikruti in skin colour. In the context of Vyanga both Shodhana and local application in the form of lepa are explained. For Local application ingredients of Varnya mahakashyaya will be taken. In Ashtang Hriday, Raktamokshan chikitsa is described in the treatment of Vynaga.Jaluakawacharan (Leech Therapy) is one of the type of raktamokshan. For this study total 35 patients will be taken & duration of study is two months.An attempt will be made to evaluate efficacy of Jalaukawachran with varnyakar lepa in vyanga w.s.r.Malesma. Results will be discussed according to data.
 
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