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CTRI Number  CTRI/2025/02/081256 [Registered on: 25/02/2025] Trial Registered Prospectively
Last Modified On: 24/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing two ayurvedic formulations Lodradi lepa and Siddhartakadi lepa in the treatment of Acne vulgaris in 80 adults (16-45 years). 
Scientific Title of Study   A Randomised Clinical Study To Compare The Efficacy Of Lodhradi Lepa And Siddharthakadi Lepa In The Management Of Mukhdushika w.s.r. To 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 Swapnil Ganpat Godase  
Designation  MD Kayachikitsa Scholar (Ayurveda) 
Affiliation  Dr VJD Gramin Ayurved Mahavidyalaya Patur Akola 
Address  OPD NO 3 Department of Kayachikitsa,Dr.VJD Gramin Ayurved Mahavidyalaya,near Renuka mata mandir,Patur,Tal-Patur,Dist-Akola Pin-444501 MAHARASHTRA INDIA Akola MAHARASHTRA 444501 India

Akola
MAHARASHTRA
444501
India 
Phone  7378470990  
Fax    
Email  swapnilgodase28@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vikramsing Chavan 
Designation  Professor Department of Kaychikista 
Affiliation  Dr.VJD Gramin Ayurved Mahavidyalay 
Address  OPD NO 3 Department of Kayachikitsa,Dr.VJD Gramin Ayurved Mahavidyalaya,near Renuka mata mandir,Patur,Tal-Patur,Dist-Akola Pin-444501 MAHARASHTRA INDIA Akola MAHARASHTRA 444501 India

Akola
MAHARASHTRA
444501
India 
Phone  8275730257  
Fax    
Email  tinavikramsing2006@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vikramsing Chavan 
Designation  Professor Department of Kaychikista 
Affiliation  Dr.VJD Gramin Ayurved Mahavidyalay 
Address  OPD NO 3 Department of Kayachikitsa,Dr.VJD Gramin Ayurved Mahavidyalaya,near Renuka mata mandir,Patur,Tal-Patur,Dist-Akola Pin-444501 MAHARASHTRA INDIA Akola MAHARASHTRA 444501 India

Akola
MAHARASHTRA
444501
India 
Phone  8275730257  
Fax    
Email  tinavikramsing2006@gmail.com  
 
Source of Monetary or Material Support  
Department of Kayachikitsa Dr.VJD Gramin Ayurved Mahavidyalaya,near Renuka mata mandir,Patur,Tal-Patur,Dist-Akola,Maharashtra,India Pin code-444501 
 
Primary Sponsor  
Name  Dr VJD Gramin Ayurved Mahavidyalaya 
Address  Dr.VJD Gramin Ayurved Mahavidyalaya,near Renuka mata mandir,Patur,Tal-Patur,Dist-Akola,Maharashtra,India Pin code-444501 
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 
Dr Swapnil Ganpat Godase  Dr. VJD Gramin Ayurved Mahavidyalaya  OPD NO 3 Department of Kayachikitsa,Dr.VJD Gramin Ayurved Mahavidyalaya,near Renuka mata mandir,Patur,Tal-Patur,Dist-Akola MAHARASHTRA
Akola
MAHARASHTRA 		 7378470990

swapnilgodase28@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Dr VJD Gramin Ayurved Mahavidyalaya, Patur, Akola  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L700||Acne vulgaris. Ayurveda Condition: YUVANAPIDAKA (MUKHADUSHIKA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-lepa, लेप (Procedure Reference: Sushrut Chikitsa Adhyay 24, Procedure details: 1.Poorva karma of Lepa : - Patients was asked to wash the face with luke warm water . Lepa was prepared by mixing Churna with water as per required consistency. 2.Pradhan karma of Lepa: - 1.Lepa was applied freshly prepared in the morning (Prathkal), keep the Lepa on the face until it gets dried. 2. Required quantity of Lepa was taken and applied to the affected site in opposite direction of the hair roots. 3. Lepa was applied with the thickness of 4-5mm. 3.Paschat Karma of Lepa: - Before complete drying of Lepa; patients were advised to wipe the lepa with wet cotton swab)
(1) Medicine Name: Lodhradi Lepa, Reference: Yogaratnakar Kshudraroga Chikitsa Prakaran, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Duration: 28 Days
2Comparator ArmProcedure-lepa, लेप (Procedure Reference: Sushrut Chikitsa Adhyay 24, Procedure details: 1.Poorva karma of Lepa : - Patients was asked to wash the face with luke warm water . Lepa was prepared by mixing Churna with water as per required consistency. 2.Pradhan karma of Lepa: - 1.Lepa was applied freshly prepared in the morning (Prathkal), keep the Lepa on the face until it gets dried. 2. Required quantity of Lepa was taken and applied to the affected site in opposite direction of the hair roots. 3. Lepa was applied with the thickness of 4-5mm. 3.Paschat Karma of Lepa: - Before complete drying of Lepa; patients were advised to wipe the lepa with wet cotton swab)
(1) Medicine Name: Siddhartakadi Lepa, Reference: Bhavprakash Madhyam Khand 61/35, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Duration: 28 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1) Patients of either sex with age group between 16 to 45 years.
2) Patients having pitika with Ruja, Daha, Shotha and Medogarbha on face will be selected for study.
3) Patient willing to give informed consent.
4) Patient willing for clinical trial.
5) Patients may diagnosed with PCOS/PCOD. 
 
ExclusionCriteria 
Details  1) Patients with Pitika other than face.
2) Patients with age below 16 years and above 45 years.
3) Patients having disease such as Kshudrakushtha, Mahakushtha,etc. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Symptoms like 1. Vedana 2. Daha 3. Shotha of Mukhadushika will be decreased with reference to Acne Vulgaris.  7 Days, 14 Days, 21 Days, 28 Days after starting treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in symptoms of Mukhadushika   18 Months 
 
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   N/A 
Date of First Enrollment (India)   07/03/2025 
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)   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       In today’s modern era due to increased competition of earning prosperity human not only adopted the new life style but also food habits of western culture which is chiefly responsible to derangement in their physiology and responsible to number of skin disease like Acne Vulgaris.(‘Mukhadushika’)
In ayurveda content sushruta has mentioned “Mukhadushika ”/ Yuvanapidika in Nidansthana 13th chapters as a separate vyadi under the one of the type of “Kshudrarogas”. In mukhdushika there is a kapha, vata, rakta dushti which leads to elevations like shalmali thorn.
    Acharya Sharangdhar has mentioned yuvan pidika (Acne Vulgaris) as the mala (waste) of shukra dhatu (semen) along with vaktra snigdhata. Shukra pradurbhava (release of shukra dhatu) takes Acne is chronic inflammation of the pilosebaceous units. It is a extremely common condition, it generally starts after puberty and there are reports of it affecting over 90% of adolescents.
     According to the modern science Acne is a common chronic inflammatory condition of skin. Acne affects both Males & Females,although males tend to have more with onset of puberty. Around the globe, Acne affected 80% of individuals between pubescence and 35 years of age . Acne vulgaris is disease of sebaceous gland. Patient having acne have an associated increased secretion of the sebaceous gland leading to increased oiliness of the skin. This is acted upon by the normal flora of the skin. Fatty acid along with the other components of the sebaceous (secretion )and the bacteria are responsible for producing the acne lesions. The lesion consists of Mukhdushika. comedones i.e black-heads , inflammatory papules, papule-pustules and cystic lesions. Ayurveda has described two types of Chikitsopkrama for the treatment of Mukhdushika
1. ShodhanUpakrama
2. Shaman Upakrama
 
1. Shodhan Upakrama : It includes panchakarma in which vitiated doshas are eliminated from the body to avoid Recurrence of disease. Shodhanchikitsa includes – Vaman,Virechana,Nasya,Siravedha etc. 
2. Shaman Upakrama : The drugs which bring the equlibrium of doshas without elimination and aggrevation is Known as Shaman Chikitsa. It includes mainly 1) Internal medication 2) Local application In Local application Lepa,Pralepa,Prakshalana are common.We have decided to Bahyachikitsa which will be affordable and Practically applicable. The study will be carried out by using Lodhradi Lepa and SiddharthakadiLepa locally. 
 
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