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CTRI Number  CTRI/2025/12/099632 [Registered on: 22/12/2025] Trial Registered Prospectively
Last Modified On: 20/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Assessment of Amlapitta in the patients of Mukhadushika (Acne Vulgaris) 
Scientific Title of Study   A CROSS-SECTIONAL OBSERVATIONAL STUDY TO ASSESS THE PREVALENCE OF AMLAPITTA AMONG DIAGNOSED CASES OF MUKHADUSHIKA. 
Trial Acronym  na 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rohit Kumar 
Designation  PG scholar 
Affiliation  All india Institue of Ayurveda 
Address  Room No.311 3rd floor Academic Block Block C Department of Roga Nidana Evam Vikriti Vigyana All India Institute of Ayurveda Gautampuri Sarita Vihar Mathura Road
Room No.311 3rd floor Academic Block Block C Department of Roga Nidana Evam Vikriti Vigyana All India Institute of Ayurveda Gautampuri Sarita Vihar Mathura Road
South
DELHI
110076
India 
Phone  9997864698  
Fax    
Email  rohitbaghel1199@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shalini Rai 
Designation  Associate Professor 
Affiliation  All india Institue of Ayurveda 
Address  Room No.311 3rd floor Academic Block Block C Department of Roga Nidana Evam Vikriti Vigyana All India Institute of Ayurveda Gautampuri Sarita Vihar Mathura Road
Room No.311 3rd floor Academic Block Block C Department of Roga Nidana Evam Vikriti Vigyana All India Institute of Ayurveda Gautampuri Sarita Vihar Mathura Road
South
DELHI
110076
India 
Phone  9389423843  
Fax    
Email  vd.raishalini@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rohit Kumar 
Designation  PG scholar 
Affiliation  All india Institue of Ayurveda 
Address  Room No.311 3rd floor Academic Block Block C Department of Roga Nidana Evam Vikriti Vigyana All India Institute Of Ayurveda Gautampuri Sarita Vihar Mathura Road
Room No.311 3rd floor Academic Block Block C Department of Roga Nidana Evam Vikriti Vigyana All India Institute Of Ayurveda Gautampuri Sarita Vihar Mathura Road
South
DELHI
110076
India 
Phone  9997864698  
Fax    
Email  rohitbaghel1199@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, Gautampuri, Sarita Vihar, Mathura road New Delhi 110076 
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 
DrRohit Kumar  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
South
DELHI 
09997864698

rohitbaghel1199@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L709||Acne, unspecified. Ayurveda Condition: KUSHTHAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1 Patients presenting with classical signs and symptoms of Mukhadushika
2 Patients in the age group of 18 to 45 years
3 Patients who provide written informed consent for participation in the study
 
 
ExclusionCriteria 
Details  1 Patients with a history of immunosuppressive therapy
2 Pregnant and lactating women
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The percentage of Mukhadushika patients reporting Amlapitta symptoms  12 months to 18 months 
 
Secondary Outcome  
Outcome  TimePoints 
Spearman’s correlation coefficient of r = 0.40 (p = 0.01) between Amlapitta symptom severity and Mukhadushika severity.  12 months to 18 months 
 
Target Sample Size   Total Sample Size="260"
Sample Size from India="260" 
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)   14/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  14/01/2026 
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  

Modern treatment approaches primarily target external symptoms but often neglect underlying systemic factors such as digestion and metabolism, which Ayurveda identifies as pivotal in disease manifestation. Recent research emphasises the role of gastrointestinal dysfunction, unhealthy dietary habits (such as consuming spicy, oily, and fast food), and psychological stress in the form of the gut-skin axis as a direct link between digestive health and skin conditions. [22]  In Ayurveda also, Amlapitta (acid dyspepsia), characterized by increased Pitta and impaired digestion, is implicated in exacerbating skin conditions through systemic toxicity (Ama) and Pitta imbalance, resulting in several skin presentations like Kandu (itching), Mandala and Kotha (elevated circular lesions similar to urticaria), Pidika (papule and pustules, which can occur over any part of the body). Despite the recognition of these internal factors in Ayurvedic texts, there is limited clinical research exploring the association between Amlapitta and Mukhadushika. This study is necessary to scientifically evaluate the association between Amlapitta and Mukhadushika. Such evidence may drive the need for integrative management protocols for acne, offering a holistic approach addressing both systemic and local factors for improved patient outcomes.

 
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