| CTRI Number |
CTRI/2025/06/089456 [Registered on: 24/06/2025] Trial Registered Prospectively |
| Last Modified On: |
20/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study Of Ayurvedic Preparations For The Management Of Mukhadushika (Acne Vulgaris). |
|
Scientific Title of Study
|
A Randomised Comparative study of Arjun twaka churna lepam and Jatiphaladi lepam in the management of Mukhadushika (Acne vulgaris). |
| 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 Snehal Vishwambhar Awad |
| Designation |
Post Graduate scholer |
| Affiliation |
Ashvin Rural Ayurved College Manchi Hill Sangamner |
| Address |
Left Wing Room No 3 Kayachikitsa Department Ashvin Rural Ayurved College and Hospital Sadvi Preeti Sudhaji Maharaj Nagar Manchi Hill Ashvi Bk Tal-Sangamner Dist Ahamadnagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
8975930610 |
| Fax |
|
| Email |
awadsnehal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Lokhande |
| Designation |
Head of Department |
| Affiliation |
Ashvin Rural Ayurved College Manchi Hill Sangamner |
| Address |
Left Wing Room No 3 Kayachikitsa Department Ashvin Rural Ayurved College and Hospital Sadvi Preeti Sudhaji Maharaj Nagar Manchi Hill Ashvi Bk Tal-Sangamner Dist Ahamadnagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
9373788599 |
| Fax |
|
| Email |
lokhandesanjeev13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjeev Lokhande |
| Designation |
Head of Department |
| Affiliation |
Ashvin Rural Ayurved College Manchi Hill Sangamner |
| Address |
Left Wing Room No 3 Kayachikitsa Department Ashvin Rural Ayurved College and Hospital Sadvi Preeti Sudhaji Maharaj Nagar Manchi Hill Ashvi Bk Tal-Sangamner Dist Ahamadnagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
9373788599 |
| Fax |
|
| Email |
lokhandesanjeev13@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Snehal Vishwambhar Awad |
| Address |
Left Wing Room No 3 Kayachikitsa Department Ashvin Rural Ayurved College and Hospital Sadvi Preeti Sudhaji Maharaj Nagar Manchi Hill Ashvi Bk Tal-Sangamner Dist Ahamadnagar
Maharashtra India
413714 |
| 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 Snehal Vishwambhar Awad |
Ashvin Rural Ayurved College Manchi Hill Sangamner |
Kayachikitsa Department Opd and Opd , Ashvin Rural Ayurved College and Hospital Sadvi Preeti Sudhaji Maharaj Nagar Manchi Hill Ashvi Bk Tal-Sangamner Dist Ahamadnagar
Ahmadnagar
MAHARASHTRA |
8975930610
awadsnehal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ashvin Rural Ayurved College Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: KSHUDRAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jatiphaladi Lepam, Reference: Yogratnakar Samhita, Adhyaya no 37, Shloka no 2, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 21 Days, Reference: No, Route: -, Dosage Form: Lepa Churna, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Arjun Twaka Churna Lepam, Reference: Yogratnakar Samhita, Adhyaya No- 37, Shloka no 4-5, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 21 Days, Reference: No, Route: -, Dosage Form: Lepa Churna, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients having symptoms of Mukhadushika as Pidika with strava, Daha, Ruja, Kandu, Shotha, Vaivarnya ( Minimum 2-3 symptoms).
2) Patients of age group 16-30 years irrespective of their gender.
3) Patients having symptoms of Mukhadushika since 2 months. |
|
| ExclusionCriteria |
| Details |
1) Associated with other local skin diseases as Vyanga, Nilika, Nyacha, Masurika.
2) Patients who use regular cosmetic products.
3) Patient suffering from any co-morbidities like Diabetes Mellitus, hypertension, Pregnant womens (ANC) etc.
4) Patients having symptoms related to hormonal imbalance. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess and compare efficacy of Arjun Twaka churna Lepam and Jatiphaladi Lepam in the management of Mukhadushika (Acne Vulgaris) by using Subjective and Objective Criteria. |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 |
|
Date of First Enrollment (India)
|
10/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/07/2026 |
| 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 Yet Recruiting |
| 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
|
Acne vulgaris is a chronic condition affecting more than 85% of adolescents & young adults.According to modern science, Acne is chronic inflammation of pilosebaceous unit due to Propilobacterium acne. And characterized by areas of the skin with seborrhoea (scaly red skin), Comedones (open & close), papules (pinheads), pustules (pimples),nodules (large papules) & Possibly scarring. In Modern medicine current treatment of Acne is done by using antibiotics, vit A. Corticosteroids, Ultraviolet radiation and lotion for the external application. But these products produces a large number of symptoms such as skin colour changes, redness, swelling, dryness and irritation of skin, crusting or blistering commonly in sensitive skin So, patients need an authentic and organic way of treatment for this issues of sensitivity. That is why there is need of such treatment that not only cures Mukhadushika (Acne vulgaris) but also free from side effects.
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