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CTRI Number  CTRI/2024/12/078478 [Registered on: 23/12/2024] Trial Registered Prospectively
Last Modified On: 11/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of Jeerakadi lepa and manjistha lepa in vyangya with reference to melasma 
Scientific Title of Study   Randomized Comparative Clinical Study to evaluate the efficacy of Jeerakadi lepa and Manjistha lepa in the Management of Vyangya w.s.r to 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 Mahesh Kishan Warwade  
Designation  MD Kaychikista Scholar (Ayurveda) 
Affiliation  Dr VJD Gramin ayurved mahavidyalaya patur  
Address  OPD no 3 Kaychikista Department Dr VJD Gramin ayurved mahavidyalaya patur near Renuka mata Mandir patur tal patur dis akola

Akola
MAHARASHTRA
444501
India 
Phone  7385555004  
Fax    
Email  warwademahesh5@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vikram Singh chavan  
Designation  Professor Department of Kaychikista  
Affiliation  Dr VJD Gramin ayurved mahavidyalaya patur  
Address  OPD no 3 Department of Kaychikista, Dr VJD Gramin ayurved mahavidyalaya patur near Renuka mata Mandir patur tal patur dis akola

Akola
MAHARASHTRA
444501
India 
Phone  8275730257  
Fax    
Email  tinavikramsing2006@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vikram Singh chavan  
Designation  Professor Department of Kaychikista  
Affiliation  Dr VJD Gramin ayurved mahavidyalaya patur  
Address  OPD no 3 Department of Kaychikista, Dr VJD Gramin ayurved mahavidyalaya patur near Renuka mata Mandir patur tal patur dis akola

Akola
MAHARASHTRA
444501
India 
Phone  8275730257  
Fax    
Email  tinavikramsing2006@gmail.com  
 
Source of Monetary or Material Support  
Department of Kayachikista,Dr VJD Gramin Ayurved Mahavidyalaya, Patur, Dis-Akola, Maharashtra, India Pin-444501 
 
Primary Sponsor  
Name  Dr VJD Gramin Ayurved Mahavidyalaya  
Address  Department of Kayachikista Dr.VJD Gramin Ayurved Mahavidyalaya, Patur Dist-Akola Pin-444501 Maharashtra,India  
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 Mahesh Kishan Warwade   Dr. VJD Gramin Ayurved Mahavidyalaya, Patur patur  OPD No.3,Department of Kaychikista,Dr.VJD Gramin Ayurved Mahavidyalaya, Patur, near Renuka Mata Mandir,Patur Tal-Patur,Dis-Akola
Akola
MAHARASHTRA 
7385555004

warwademahesh5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Dr. VJD Gramin Ayurved Mahavidyalaya, Patur, Akola  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
1Comparator ArmProcedure-lepa, लेप (Procedure Reference: Sharangdhar Samhita Madhyam khand, Procedure details: Procedure details: द्रव्यमार्दशिलापिष्टंशुष्कंवासद्रवंतनु । देहेप्रलेपनार्थतल्लेपइत्युच्यतेबुधैः ॥ [ शा.सं.म. 5 / 2] All ingredients of Manjistha Lepa will be taken in equal quantity & mixed it with water (as per requirement) & prepared paste.))
(1) Medicine Name: Manjistha lepa, Reference: व्यङ्गेषु चार्जुनत्वग्वा मञ्जिष्ठा वा समाक्षिका । लेपः सनवनीता वा श्वेताश्वखुरजा मयी ।। १६ ।।... अ.हृ.उ.32/16], Route: Topical, Dosage Form: Lepa Churna, Dose: 50(g), Frequency: od, Duration: 28 Days
2Intervention ArmProcedure-lepa, लेप (Procedure Reference: Sharangdhar Samhita Madhyam Khand , Procedure details: Procedure details: द्रव्यमार्दशिलापिष्टंशुष्कंवासद्रवंतनु । देहेप्रलेपनार्थतल्लेपइत्युच्यतेबुधैः ॥ [ शा.सं.म. 5 / 2] All ingredients of Jeerakadi Lepa will be taken in equal quantity & mixed it with water (as per requirement) & prepared paste.)))
(1) Medicine Name: Jeerakadi lepa , Reference: द्वे जीरके कृष्णतिलाः सर्षपाः पयसा सहः । पिष्टाः कुर्वन्ति वक्तेन्दुमपास्तव्यङ्गलाञ्छनम् ।।... अ.हृ.उ.32/18], Route: Topical, Dosage Form: Lepa Churna, Dose: 50(g), Frequency: od, Duration: 28 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Patients having clinical features of Vyanga.

2.Patients willing to sign the informed consent form.

3.Patient of either gender, irrespective of socioeconomic status.

4.Patients not using any topical treatment for melasma prior to enrollement in study. 
 
ExclusionCriteria 
Details  1.Patients taking O.C.Pills.

2.Patients suffering from other skin disorder and other systemic disorder.

3.Patients associated with any serious systemic disorders.

4.History of Allergy to topical application.

5.Cancer of skin.
 
 
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 
Symptoms of Vyangya like
1. Black spot
2.Brown spot
3.itching



All the above symptoms Will be decreased and control over Vyangya with reference to 2.melasma  
7,14,21,28 Days Symptoms will be Observed  
 
Secondary Outcome  
Outcome  TimePoints 
Decreased in symptoms of Vyangya & hyperpigmmantion
Like darkness black spot  
18 month 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   25/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/12/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="6" 
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   Ayurveda is an eternal life science and the main aim of Ayurveda is promotion of health and eradication of the diseases. The Beauty and Attraction of individual is reflected in the skin’s health. Skin diseases though afflicts bodily but gives lot of psychological disturbances.

Vyanga is the one of the Kshudra Roga, which is characterized by Neeruja (painless), Shyava Varna Mandalas (bluish black patches) occurring especially on the face. While considering the pathogenesis of Vyanga, involvement of Pitta is more and it is Rakta Pradoshaja Vyadhi.

On the basis of clinical features it is correlated with melasma, or facial melanosis, one of the hyper pigmented disorders. Melasma is a common acquired hypermelanosis that affects sun- exposed areas of skin. This study is important since melasma is a disease causing mental side effects in patients, due to darkness and opacity of the skin; therefore, the treatment of melasma in terms of its psychological complication is of particular importance.

Hyperpigmentation (melanosis) is a group of disorders characterized by abnormally darker skin that results from increase in the concentration of pigment, which occurs either due to increased number of melanocytes or increase activity of melanocytes.

Now a day’s Vyanga becomes one of the biggest problems of the society. Many people are suffering from Vyanga today. Among them women are commonly found due to changes occurring during pregnancy and use of cosmetic supplements.
In the context of Vyanga both Shodana and Shamana Chikitsa are explained in the form of Raktamokshana, Lepa, Abhyanga and oral medication".

Need of the study -

Pigmentation are seen especially on cheeks, nose, forehead and chin. The Prevalence of melasma varies between 1.5% and 33.3% depending on the population. Its Prevalence in women is around 50%- 70% in Pregnancy stage. In men its 20.5-25.38% of the cases.

Acharya charaka has broadly classified chikitsa under three main headings, namely Antah Parimarjana, Bahir Parimarjana and Shastra Prranidhana. Lepa kalpana is the Upakalpana, which comes under Bahir Parimarjana Chikitsa . The Lepa which is applied on the face gives strength to the muscle of eyes, cheeks has to be thick which enhance face complexion which in turns cures Vyanga. Alepa normalizes Rakta and Pitta.

So, the Lepa which is one of the forms of external application for skin diseases is taken for this study. Jeerakadi Lepa & Manjishtha Lepa is mentioned in the Ashtanga Hrudaya Chikitsathana for the management of Vyanga Chikitsa.
 
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