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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:L814||Other melanin hyperpigmentation. Ayurveda Condition: VYANGAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | jalaukAvacaraNam, जलौकावचरणमॠ| (Procedure Reference: Asthang hridayam Uttar Tantra 32/15, Procedure details: Jalaukawacharan will be done two times at first day & fifteenth day.)
| 2 | Intervention Arm | Drug | Classical | | (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 “Kshudrarogaâ€.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. |