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CTRI Number  CTRI/2026/01/101781 [Registered on: 22/01/2026] Trial Registered Prospectively
Last Modified On: 26/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Open-labeled parallel study on vyanga (hyperpigmentation) and impact of vatankura lepa and manjishtha churna (oral) along with mantra chikitsa and assessment of manasika bhava in vyanga (Hyperpigmentation)  
Scientific Title of Study   Assessment of manasika bhava in vyanga (melasma) and upshayatmaka effect of vatankura lepa and manjistha churna (oral) along with mantra chikitsa: an open-labeled parallel study 
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 Devashish 
Designation  MD scholar 
Affiliation  ALL INDIA INSTITUTE OF AYURVEDA 
Address  Department of Roga Nidana Evum Vikriti Vigyan, 3rd floor, Academic block , Block C, All India Institute of Ayurveda, Gautampuri, Sarita vihar , Mathura road , New Delhi

South
DELHI
110076
India 
Phone  09625170584  
Fax    
Email  dev01delhi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shalini Rai 
Designation  Associate Professor 
Affiliation  ALL INDIA INSTITUTE OF AYURVEDA 
Address  Department of Roga Nidana Evum Vikriti Vigyan, 3rd floor, Academic block , Block C, All India Institute of Ayurveda, Gautampuri, Sarita vihar , Mathura road , New Delhi

South
DELHI
110076
India 
Phone  9389423843  
Fax    
Email  vd.raishalini@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Devashish 
Designation  MD scholar 
Affiliation  ALL INDIA INSTITUTE OF AYURVEDA 
Address  Department of Roga Nidana Evum Vikriti Vigyan, 3rd floor, Academic block , Block C, All India Institute of Ayurveda, Gautampuri, Sarita vihar , Mathura road , New Delhi

South
DELHI
110076
India 
Phone  09625170584  
Fax    
Email  dev01delhi@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda ,Gautampuri, Sarita vihar,Mathura road , New Delhi 110076 
 
Primary Sponsor  
Name  All India Institute of Ayurveda  
Address  All India Institute of Ayurveda ,Gautampuri, Sarita vihar,Mathura road , New Delhi 110076 
Type of Sponsor  Research institution and hospital 
 
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 Devashish  All India Institute of Ayurveda  Department of Roga Nidana Evum Vikriti Vigyana,OPD ground floor,Hospital Block,All India Institute of Ayurveda,Gautampuri,Sarita vihar,Mathura road,New Delhi 110076
South
DELHI 
09625170584

dev01delhi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee , All India Institute of Ayurveda,New Delhi  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-mantra-cikitsA, मन्त्र-चिकित्सा (Procedure Reference: 19. Saini M, Gurjar A, Muthukrishnan SP, Kaur S, Sharma R, Tayade PT. Global effect on cortical activity in young Indian males in response to “OM” chanting: a high-density quantitative electro-encephalography study. Ann Neurosci. 2023 Aug 17;31(3):176–85. doi:10.1177/09727531231183219. PMID: 39156622; PMCID: PMC11325691, Procedure details: Patients will be advised to practice Om Mantra once daily between 6:00–8:00 AM on an empty stomach, after attending to natural urges, as per the SOP. They should sit comfortably with a straight back and closed eyes in a quiet, dimly lit room (or any comfortable position if unable to sit). The session will include: 5 min listening to “Om” chanting with deep breathing, 5 min quiet deep breathing, 5 min active “Om” chanting (as per Saini M. et al., 2023). Patients will record their daily practice in the provided log and may contact the researcher for any queries during the study. )
(1) Medicine Name: Vatankura lepa, Reference: yogratnakar, Route: Topical, Dosage Form: Lepa Churna, Dose: 3(g), Frequency: od, Duration: 45 Days
(2) Medicine Name: manjishtha churna, Reference: chakradutt, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 45 Days
2Comparator ArmDrugClassical(1) Medicine Name: vatankura lepa, Reference: yogratnakar, Route: Topical, Dosage Form: Lepa Churna, Dose: 3(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: manjishtha churna, Reference: chakradutt, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: madhu), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  38.00 Year(s)
Gender  Both 
Details  1) patient diagnosed with vyanga (melasma) on the basis of clinical signs and symptoms.
2) patient willing to give written informed consent and follow up.
3) Patients of age group 18-38 years irrespective of sex, religion, or occupation.
4) Disease chronicity not more than 5 yr.
5) patients with controlled hypothyroidism and diabetes.
6) patient of vyanga showing the presence of Manasika bhava in any grade.

 
 
ExclusionCriteria 
Details  1. Pregnant women and lactating mothers.
2. Patients below 18 years and above 38 yr of age.
3. Severe dermatological disorders (e.g., eczema, psoriasis).
4. Patient with uncontrolled hypothyroidism (TSH Greater than 5mIU/L) and diabetes
(HbA1c More than 6.5%).
5. Patient on hormonal therapy.
6. Patient not willing to participate in clinical trial.
7. Patient with any hearing impairment. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• A higher prevalence of Mansika Bhava is present in vyanga (melasma).
• Change in MASI (Melasma Area and Severity Index) SCALE after the treatment.
• Improvement/resolution in signs and symptoms of Vyanga (Melasma). 
for an interventional study
Percentage change of the clinical sign and symptoms of vyanga in both the groups after 45 days i.e. follow up 2 months and observing the effect of drugs on manasika bhava
 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the therapeutic effect along with Mantra chikitsa on serum cortisol level,
and fMRI, EEG (electroencephalogram) (if the facility is available in AIIA). 
change in Manasika bhava score in both the group i.e.0th , 15th,30th,45th day.
If facility available in AIIA assessment of EEG and fMRI,in mantra chanting group on 0th and 45th day on as first cum first service (only 10 patient)  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   27/01/2026 
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  
One of the Kshudraroga  Vyanga is distinguished by the presence of Shyavavarna bluish black
patches  Niruja painless Mandalas on the face. It is among the most prevalent
conditions affecting the face. It is comparable to face melanosis  one of the hyperpigmented
illnesses  based on clinical characteristics. In addition to helping with Raktashodhana blood
cleansing  drugs having Rakta Prasadaka  Twak Prasadaka  and Varnyakara qualities are
useful in the treatment of Vyanga. 
Melasma is a common skin problem caused by brown to gray brown patches on the face. Most
people get it on their cheeks  chin  nose bridge  forehead  and above the upper lip. It is more
common in women than men. Pregnancy is a common cause of melasma. It also affects women
taking oral contraceptives and hormones. The prevalence of melasma is from 1 percent in the
general population to 9 to 50 percent in high risk population. 
Melasma is an acquired hyper melanosis characterized by asymmetric  brown coloured 
irregular  reticulated macules on sun exposed areas of the skin  especially the face. While  skin
pigmentation from sun tanning and post  hyperpigmentation fades spontaneously
after the stimulus cessation in melasma  this reduction usually does not occur. Melasma
evolves from alterations in several skin layers and cell types to hyper functional melanocytes 
which produce and transfer mature melanosomes to the whole epidermis
Need of the study
Vyanga Melasma is a common skin disorder that often leads to significant psychological
distress among affected individuals. Conventional treatments for melasma have limited success
and may be associated with undesirable side effects. Ayurveda provides holistic approaches
for managing Vyanga focusing on both internal and external therapies.
There is currently no concrete evidence regarding the role of Manasika bhava psychological
factor in the development or management of Vyanga. However  Ayurveda classics have
described regarding the etiological role of krodha and shoka in the development of vyanga.
Therefore  assessing the impact of Manasika bhava and exploring integrative therapies that
combine Ayurvedic and psychological interventions may offer safer  more effective  and
evidence based solutions for patients.

AIM AND OBJECTIVE
AIM
To assess the role of Manasika bhava Hetu in the manifestation of vyanga  Melasma and to
evaluate the clinical efficacy of Vatankura Lepa and Manjishtha churna along with Mantra
chikitsa in its management.
 OBJECTIVES
PRIMARY OBJECTIVE
To assess the prevalence of Manasika bhavas in the manifestation of Vyanga
Melasma.
 To evaluate the therapeutic Upshayatmaka effect of Vatankura Lepa in combination
with Manjishtha churna and add on effect of Mantra Chikitsa on Vyanga Melasma.
SECONDARY OBJECTIVES
 To evaluate the therapeutic effect along with Mantra chikitsa on serum cortisol level 
and fMRI  EEG electroencephalogram if facility available in AIIA.
 Expected outcome
PRIMARY OUTCOME
A higher prevalence of Mansika Bhava is present in vyanga Melasma.
 Change in MASI Melasma Area and Severity Index SCALE after the treatment
Improvement and resolution in sign and symptoms of Vyanga Melasma.
SECONDARY OUTCOME
Change in serum cortisol level alpha MSH  IgE level  EEG  fMRI.
 Change in Perceived stress scale.
 
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