| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: - | | 2 | Intervention Arm | Drug | Classical | | (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. |