FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/080706 [Registered on: 17/02/2025] Trial Registered Prospectively
Last Modified On: 21/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Single Arm Study 
Public Title of Study   Management of vyanga (melasma) through raktachandanadi lepa 
Scientific Title of Study   An open labelled single arm prospective clinical trial to evaluate the efficacy of raktachandanadi lepa in vyanga 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 Naini Jain 
Designation  MD Scholar 
Affiliation  Govt. Ayurveda College Rewa 
Address  Dept. Of Samhita Siddhant Govt. Ayurveda College Nipaniya Rewa M.P.

Rewa
MADHYA PRADESH
486001
India 
Phone  9399415532  
Fax    
Email  jainnayan90.16@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pravanjan Acharya 
Designation  Professor and H.O.D 
Affiliation  Govt. Ayurveda College Rewa 
Address  Dept. Of Samhita Siddhant Govt. Ayurveda College Nipaniya Rewa M.P.

Rewa
MADHYA PRADESH
486001
India 
Phone  9827459956  
Fax    
Email  dr.pravanjan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vivek Shrivastava 
Designation  Associate Professor 
Affiliation  Govt. Ayurveda College Rewa 
Address  Dept. Of Samhita Siddhant Govt. Ayurveda College Nipaniya Rewa M.P.

Rewa
MADHYA PRADESH
486001
India 
Phone  9827737208  
Fax    
Email  dr.vivek.stv@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda College Nipaniya Rewa Madhya Pradesh 486001 India 
 
Primary Sponsor  
Name  Govt. Ayurveda College Rewa M.P. 
Address  Govt. Ayurveda College Nipaniya Rewa M.P. PIN CODE 486001 Madhya Pradesh 
Type of Sponsor  Government 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 
Naini Jain  Government Ayurveda College Nipaniya Rewa Madhya Pradesh 486001 India  Government Ayurveda College Nipaniya Rewa Pin code 486001 Madhya Pradesh India
Rewa
MADHYA PRADESH 		 9399415532

jainnayan90.16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L819||Disorder of pigmentation, unspecified. Ayurveda Condition: VYANGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-lepa, लेप (Procedure Reference: Ashtang Hridayam Sutrasthan 22/15, Procedure details: Lepa should be applied evenly on affected parts of face. Then it should be left for 15 minutes approximately. Then it should be removed before drying by gently massaging it on the face.)
(1) Medicine Name: Raktachandanadi lepa , Reference: Ashtang Hridayam Uttarsthan 32/17, Route: Topical, Dosage Form: Lepa Churna, Dose: 6(g), Frequency: bd, Duration: 21 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients presenting with the classical signs of melasma(vyanga) according to ayurveda and modern text.
2. Brown patches present only on face region.
3. Chronicity less than 3 years.
4. Patients fulfilling the diagnostic criteria. 
 
ExclusionCriteria 
Details  1. Inflammatory pigmentation, malignant melanoma, Acne Vulgaris.
2. Painful and hard lesions.
3. Patches on neck and upper chest.
4. Patients on certain medications(OCP, HTN)
5. Patients having vyanga since birth(Nevus of OTA) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in subjective parameters like shyava, niruja and tanu mandala on mukha.  from 0 to 21 days 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of trial drugs in improving the signs and symptoms as per assessment criteria and MASI score.  After 21 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 3 
Date of First Enrollment (India)   25/04/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Title - 

AN OPEN LABELLED SINGLE ARM PROSPECTIVE CLINICAL TRIAL TO EVALUATE THE EFFICACY OF RAKTACHANDANADI LEPA IN VYANGA W.S.R. TO MELASMA

Aim - 

·      To assess the efficacy of Raktachandanadi lepa in the management of Vyanga.

Objectives - 

·       To elaborate the Ayurvedic etiopathology and symptomatology of Vyanga and identify its correlation with melasma.

·       To discuss the treatment principles mentioned in various Samhita for the management of the disease vyanga.

Introduction - 

Vyanga has been described under kshudra roga by Acharya Sushruta and Acharya Vagabhatta. Kshudra roga, as the name suggests, are generally not very significant diseases in terms of causing suffering to patients yet, these are difficult to get rid of.

Vyanga is caused due to anger and physical exertion which vitiates vata and pitta doshas which in turn reflect the classical symptoms of vyanga such as aruja (painless), tanu (thin layered), shyava (dark colored /brown), mandal (circular patches) on face.

Clinical features of melasma are similar to those of vyanga. Melasma is most common pigmentary disorder with symmetrical brown patches and irregular edges. It is also known as chloasma or mask of pregnancy. Causes of melasma are unknown but probable factors include UV radiation, cosmetic procedures, oral contraceptive pills and hormonal disturbances.

Need of research - 

MELASMA is common pigmentary disorder in India with prevalence of 0.25-4%. There are many treatment principles in classical text to treat vyanga but lepana plays a vital role as it is applied directly on the affected part. Vyanga is such a condition which affects the beauty as well as personality so, person may suffer from inferiority complex, anxiety, isolation etc. This study therefore aims to testify the result of raktachandanadi lepa in the management of vyanga on the contrary of chemical peeling, laser, microneedling. Also, this study aims to improve care coordination and communication in order to advance the diagnosis of melasma and improve outcomes.

Study Design - 

Study Type : Interventional

Purpose : Treatment

Masking : Open Labelled, Clinical Trial

Direction : Prospective

End point : Efficacy

No. of Groups : single Group

Sample Size : 30 Patients

Probable Mode of Action of Drug - 

Raktachandanadi Lepa incorporates various ingredients traditionally believed to ameliorate skin health and appearance.The blend of dravya (herbal constituents) in this formulation works synergistically to enhance skin luster and reduce dryness. This lepa is applied locally on the face, promoting improved skin texture and minimizing discoloration through its various beneficial properties, including twakdoshahara which helps in skin ailments

Raktachandana which is known for its blood-purifying properties.

Manjishtha which supports even skin tone.

Lodhra which is Raktapittanut, Kaphapittanut

Kushtha having Raktashodhak, Kushthaghna, Varnya properties

Priyangu is also Raktashodhak,Twagdoshahar

Vatankur which is Varnya, kaphapittahar

Masur having Varnykar properties to improve skin texture.

Treatment regimen - 

Drug : Raktachandanadi lepa

Form : Lepa

Treatment Duration : 21 Days

Follow up : 6 months

Thickness of lepa : According to Maharshi Sharangadhara the thickness of the Varnya Lepa should be ½ (9.75mm) Angula 

 Dose : Quantity required as per the area of the affected part. 


 
Close