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CTRI Number  CTRI/2024/11/077043 [Registered on: 19/11/2024] Trial Registered Prospectively
Last Modified On: 14/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical study of Arjuna, Manjishtha and Vasa (AMV) Cream in the treatment of Vyanga(Black discoloration of skin) 
Scientific Title of Study   Pharmaceutical Development, Standardization and Clinical Evaluation of the efficacy of Arjuna, Manjishtha and Vasa (AMV) Lepa and Cream in Vyang (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  Sabahat Anjum 
Designation  MD Scholar 
Affiliation  Ayurvedic and Unani Tibbia college and Hospital 
Address  PG Department of Dravyaguna Ayurvedic and Unani Tibbia College and Hospital Karol Bagh New Delhi

Central
DELHI
110005
India 
Phone  8376954818  
Fax    
Email  dranjum.sabahat@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shalini Varshney 
Designation  Associate Professor 
Affiliation  Ayurvedic and Unani Tibbia College and Hospital 
Address  PG Department of Dravyaguna Ayurvedic and Unani Tibbia College and Hospital Karol Bagh New Delhi.

Central
DELHI
110005
India 
Phone  9354925050  
Fax    
Email  shalinidr.v7@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shalini Varshney 
Designation  Associate Professor 
Affiliation  Ayurvedic and Unani Tibbia College and Hospital 
Address  PG Department of Dravyaguna Ayurvedic and Unani Tibbia College and Hospital Karol Bagh New Delhi.

Central
DELHI
110005
India 
Phone  9354925050  
Fax    
Email  shalinidr.v7@gmail.com  
 
Source of Monetary or Material Support  
Ayurvedic and Unani Tibbia College and Hospital Opd No 18 Karol Bagh New Delhi 110005 
 
Primary Sponsor  
Name  Ayurvedic and Unani Tibbia College and Hospital 
Address  Ayurvedic and Unani Tibbia College and Hospital Karol Bagh, New Delhi 110005 
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 
Dr Sabahat Anjum  Ayurvedic and Unani Tibbia college and Hospital  OPD No 18 PG Department of dravyaguna Karol Bagh
Central
DELHI 		 8376954818

dranjum.sabahat@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee A and U Tibbia College and Hospital Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L811||Chloasma. Ayurveda Condition: VYANGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: AMV (Arjuna, Manjishtha and Vasa) Cream, Reference: Yogratnakar, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -Quantity sufficient in thin layer as per surface area
2Comparator ArmDrugClassical(1) Medicine Name: Arjuna Manjishtha and Vasa( AMV) Lepa, Reference: Yogratnakar, Route: Topical, Dosage Form: Lepa Churna, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -Quantity sufficient as per surface area
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1.Patients belonging to the age group of 25 to 55 years
2. Patients with the classical signs and symptoms of disease Vyanga (Melasma) i.e Shyava (Varna), Tanu (alpa), Niruja mandalas
3.Patients having the chronicity of disease for less than 5 years
4.Patients not using any topical treatment for melasma for 2 weeks prior to
enrollment in the study
5.Patients willing to participate in study trial and give written informed consent 
 
ExclusionCriteria 
Details  1. Pregnant women and lactating mothers.
2. Vyanga (Melasma) caused since birth like Nevus of Ota etc.
3. Patients having Vyanga (Melasma) as a symptom of major systemic diseases like S.L.E, Addison’s disease etc., or as a result of adverse effect of any drug or caused by tumor like malignant melanoma.
4. Patients taking oral contraceptive pills & injected depot contraceptive preparations. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Prepared and standardized AMV Cream.
2. Improvement in Clinical signs and symptoms of Vyanga (Melasma)
4. Improvement in Melasma Area and Severity Index Score (MASI Score)
4. Improvement in Physician global assessment scale (PAGI) 		 2 months 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in the Melasma Quality of Life index (MELAS Qol)  2 months  
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   01/12/2024 
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="6"
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  
Among the numerous conditions that impact cosmetic appearance, Vyanga stands out as a prevalent skin ailment recognized from thousands of years. Though it is considered as Kshudra Rog (minor disease), it holds major importance as a cosmetic problem within the society.As per Ayurveda classics, Vyanga has been described by Acharya Sushruta with 
characteristics features of Niruja (painless), Tanu (thin) and Shayava varna Mandalas (bluish-black patches) on face. Acharya Charak has also described Vyanga as a “Bahirmargaj vyadhi”, the disease that occurs in the extremities. Acharya Vagbhat has mentioned Vyanga in Kshudra roga characterized by Shyama (Dark coloured/Black), Tanu (thin), Mandal (circular) patches on face.Only Ashtanga Sangraha and Ashtanga Hrudaya have mentioned types of Vyanga along with the symptoms on the basis of Doshik predominance.

On comparative analysis of Vyanga with the modern medical science Melasma show congruence with Vyanga Melasma is a skin condition characterized by the development of brown to gray-brown patches or spots on the skin, commonly on the face. The reported prevalence of melasma ranges from 0.25 - 4.0% in several southeast Asian population.
In Ayurvedic literature, Lepa (external application), Siravyadha (bloodletting) Abhyanga (oil massage) and Nasya (nasal drop instillation) are described as therapeutic options for the management of Vyanga. Among them Lepa is considered to be one of the simple & effective procedure. This study aims to evaluate the effiacy of Arjuna Manjishtha and Vasa (AMV) Lepa in Vyanga ( melasma)as mentioned in Yogratnakar Kshudrarog adhikar .Since the preparation and application of Lepa is inconvenient, time consuming and fairly cluttered for patients in comparison to cream. Keeping this in view, Cream is also developed for local application in present study and Evaluated for its clinical effficacy in Vyanga (melasma).
 
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