| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L709||Acne, unspecified. Ayurveda Condition: KUSHTHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| 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. |