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CTRI Number  CTRI/2025/12/098490 [Registered on: 04/12/2025] Trial Registered Prospectively
Last Modified On: 01/06/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical trial of ayurvedic medicine in pimples 
Scientific Title of Study   Effect of mukhalepa visha chikitsa in mukhadushika w.s.r. to acne vulgaris- An open labelled clinical trial 
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 AKANKSHA AJIT KANEKAR 
Designation  PG SCHOLAR 
Affiliation  KAHER Shri BMK Ayurveda Mahavidyalaya Shahapur Belgaum 590003 Karnataka India 
Address  Department of Agada tantra KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belgaum 590003 Karnataka India

Belgaum
KARNATAKA
590003
India 
Phone  7767067032  
Fax    
Email  25akanksha25@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR AKANKSHA AJIT KANEKAR 
Designation  PG SCHOLAR 
Affiliation  KAHER Shri BMK Ayurveda Mahavidyalaya Shahapur Belgaum 590003 Karnataka India 
Address  Department of Agada tantra KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belgaum 590003 Karnataka India

Belgaum
KARNATAKA
590003
India 
Phone  7767067032  
Fax    
Email  25akanksha25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mahesh P Savalagimath 
Designation  Professor and HOD 
Affiliation  KAHER Shri BMK Ayurveda Mahavidyalaya Shahapur Belgaum 590003 Karnataka India 
Address  Department of Agada tantra KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belgaum 590003 Karnataka India

Belgaum
KARNATAKA
590003
India 
Phone  9845430626  
Fax    
Email  vaidyamaheshps@gmail.com  
 
Source of Monetary or Material Support  
KAHERs Shri BMK Ayurved Mahavidyalaya and hospital Shahapur Belgaum 590003 Karnataka India 
 
Primary Sponsor  
Name  DR AKANKSHA AJIT KANEKAR 
Address  Department of Agada tantra KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belgaum 590003 Karnataka India 
Type of Sponsor  Other [self] 
 
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 AKANKSHA AJIT KANEKAR  KLE Ayurveda Hospital And Medical Research Centre Shahapur Belgaum KARNATAKA  Department of Agada tantra KLE Ayurveda Hospital and Medical Research Centre Shahapur Belgaum Karnataka
Belgaum
KARNATAKA 
7767067032

25akanksha25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for research on Human Subjects KAHERs Shri BMK Ayurveda Mahavidyalaya & KLE Ayurveda Hospital Shahapur Belgaum  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: YUVANAPIDAKA (MUKHADUSHIKA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: bilwadi agada, Reference: asthanga hridaya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Madhukapayasyadi lepa, Reference: Ashtanga sangraha, Route: Topical, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: -local application with lukewarm water
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1 Subjects presenting with lakshnans like Pidika Shopha Daha Ruja Kandu
2 Participants diagnosed with Acne vulgaris with mild to moderate acne as per simple clinical assessment or GAGS score less than 31
3 Participants willing for informed consent and follow up 
 
ExclusionCriteria 
Details  1 Pregnancy lactation and known or suspected cases of Polycystic ovarian syndrome
2 Patients with clinically diagnosed hormonal imbalances like thyroid disorders
3 Complicated acne associated with infection or participants taKing medicines for acne treatment for more than 3 months
4 Subjects with other skin disorders like Rosaceae Acne fulminans Acneiform eruptions
5 Subjects with acne having inflammatory cysts and nodules
6 Participants suffering from major systemic disorders like Uncontrolled hypertension Diabetes mellitus Ashtma Tuberculosis HIV 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in Global Acne Grading System(GAGS) Score  Baseline,14th and 28th day 
 
Secondary Outcome  
Outcome  TimePoints 
Global acne grading system score  Baseline,14th and 28th day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/05/2026 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
Acne vulgaris is one of the most prevalent chronic inflammatory dermatoses worldwide, primarily affecting the pilosebaceous units of the face, chest, and back. Globally, it is estimated that 9.4 percent of the population is affected by acne, making it the eighth most prevalent disease. From an Ayurvedic perspective, Mukhadushika is described under Kshudra roga, characterized by Shalmali kantaka sadrisha pidakas predominanatly on the face.
 
In India, recent epidemiological studies suggest that acne affects up to 60 to 70 percent of adolescents and young adults, with increasing incidence in females aged 15 to 30 years. Current therapeutic approach includes topical and systemic retinoids, antibiotics, benzoyl peroxide and hormonal agents for symptomatic relief. Long term use poses challenges like antibiotic resistance, photosensitivity, teratogenicity, relapse post-therapy, and limited tolerability. Factors like poor diet, urban pollution and altered gut skin axis can lead to a state resembling Visha dushti, manifesting as twak vikara.Visha Chikitsa, traditionally used to neutralize and expel toxins, can be conceptually extended to manage skin conditions where toxic byproducts, immune hypersensitivity, or impaired dhatvagni may be involved.
 
In Mukhadushika clinically, the lesions are described as Shalmali Kantakopama Pidaka, eruptions resembling the thorns of Shalmali tree, indicating hard, painful, and inflamed lesions consistent with acne. Parallelly, Ashtanga Sangraha in the context of Visha Chikitsa describes a condition known as Mukhalepa Visha, presenting with symptoms such as Padmini Kantaka Pidaka, which are elevated eruptions resembling the thorns of a lotus plant. Although attributed to toxic external applications, the morphological similarity of these eruptions to those seen in Mukhadushika is notable. 

The present clinical trial proposes the application of madhukapayasyadi lepa, and administration of Bilwadi agada internally, having pharmacological activities, which are Vishghna ,Shothaghna, Janthughna and Krimighna. Studies have shown it to be anti-microbial, antiseptic and antifungal. This dual approach aims to not only treat acne but also to explore the therapeutic versatility of Agada Tantra in dermatology and support long term dermal health without the drawbacks of conventional drugs.
 
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