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CTRI Number  CTRI/2025/06/089022 [Registered on: 18/06/2025] Trial Registered Prospectively
Last Modified On: 17/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   ROLE OF VATAPATRADI LEPA IN THE MANAGEMENT OF MUKHADUSHIKA w.s.r TO ACNE VULGARIS" 
Scientific Title of Study   A RANDOMISED OPEN-LABELLED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF VATAPATRADI LEPA IN THE MANAGEMENT OF MUKHADUSHIKA w.s.r 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 Shivani Mishra 
Designation  Pg Scholar 
Affiliation  Jammu Institute of Ayurveda and Research Nardani Kot Balwal Road Jammu 
Address  Dept. of PG Studies in Kayachikitsa Jammu Institute of Ayurveda and Research,Kot Bhalwal road Nardani Jammu and Kashmir Jammu Institute of Ayurveda And Research Jammu JAMMU & KASHMIR 181123 India

Jammu
JAMMU & KASHMIR
181123
India 
Phone  6006912792  
Fax    
Email  shivanimishra5474@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nitin Mahajan  
Designation  Principal 
Affiliation  Jammu Institute of Ayurveda and Research 
Address  Dept. of PG Studies in Kayachikitsa Jammu Institue of Ayurveda and Research, Kot Bhalwal road Nardani Jammu and Kashmir JAMMU INSTITUTE OF AYURVEDA AND RESEARCH Jammu JAMMU & KASHMIR 181123 India

Jammu
JAMMU & KASHMIR
181123
India 
Phone  9419119123  
Fax    
Email  drnitinmahajan1608@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nitin Mahajan  
Designation  Principal 
Affiliation  Jammu Institute of Ayurveda and Research 
Address  Dept. of PG Studies in Kayachikitsa Jammu Institue of Ayurveda and Research, Kot Bhalwal road Nardani Jammu and Kashmir JAMMU INSTITUTE OF AYURVEDA AND RESEARCH Jammu JAMMU & KASHMIR 181123 India

Jammu
JAMMU & KASHMIR
181123
India 
Phone  9419119123  
Fax    
Email  drnitinmahajan1608@gmail.com  
 
Source of Monetary or Material Support  
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH NARDANI JAMMU 181123 INDIA 
 
Primary Sponsor  
Name  JAMMU INSTITUTE OF AYURVEDA AND RESEARCH 
Address  Kot Balwal, Nardani ,Jammu, Jammu & Kashmir 
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 Shivani Mishra  JAMMU INSTITUTE OF AYURVEDA AND RESERACH  Room no. 102 First Floor Department pf Kayachikitsa Jammu JAMMU & KASHMIR
Jammu
JAMMU & KASHMIR 
6006912792

shivanimishra5474@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:8||Other Procedures. Ayurveda Condition: (1) M, (2) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: PIDAKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Vatapatradi Lepa, Reference: Sharangdhara samhita, Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Shalmaliadi Lepa, Reference: Sharangdhara samhita, Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1. Patients of age 16-30 yrs. will be taken for study.
2. Patients representing signs and symptoms of Mukhadushika who will be willing to participate in study .
3. Subjects of both genders will be considered. 
 
ExclusionCriteria 
Details  1. Patients with severe nodular acne.
2. Pregnancy and nursing women.
3. Acne caused by the dandruff will be excluded.
4. Patient having any systemic pathology.
5. Clinically infected lesion that require. treatment with systemic antibiotics and or local antiseptic and or other treatment.
6. Patient on any other anti acne therapy 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
SUBJECTIVE CRITERIA:
1.Number of Pidika
2.Area occupied by Pidika
3.kandu
4.Daha
5.Paka
6.Srava
7.Vedana 
Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Number of Pidika
Area occupied by Pidika 
Baseline 15th day,30th day,45th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/07/2025 
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="0"
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  

Mukhadushika’ is one of such diseases  illustrated in Ayurveda which affects the beauty of the face. This diseases has been described under Kshudraroga in the classical text. Acharaya Shusruta first described Mukhadushika  in  Kshudraroga  in  Nidaansthan 13 /38 in Chikitsasthana 20/37 .It occurs due to vitiation of kapha Dosha, Vata Dosha and  Rakta Dhatu. In Mukhadushika the eruption  like Shalmali Kantaka.The common site of Mukhadushika is face, in which forehead,cheeks,nose, and chin are the prominent sites .

It can be coorelated with Acne Vulgaris in modern science . Acne Vulgaris is an incredibly common cutaneous inflammatory  skin disorder in developed  nation as well as in developing countries like India . In this condition many teenagers, characterized by blockage of pilosebaceous duct and  involves area of skin where sebaceous glands are most numerous and active  .However , with the rise in hormones, food sensitivities, digestive problems, toxic environments, stress, high carbohydrate diets, and mineral and vitamins deficiencies, acne plagues all ages .

Topical Antibiotic therapy is recommended for its treatment but their chemical compounds creates adverse effects on the body, so natural non toxic medicines should be used to bring the skin into normal state by treating problem like Mukhadushika . Acne Vulgaris develops as a result of  hypersensitivity of the sebaceous glands to normal levels of circulating androgens. This process is further exacerbated by the presence of Cutibacterium acnes [ C acnes ]

In Mukhadushika  Saruja (painfull),  Pidika (eruption) are hallmarks of Mukhadushika . Vitiated Dosha get accumulated and obstruct the Lomarupa (pilosebaceous unit) causing local swelling and micro comedone formation .Paka (inflammation) of these elements leads to papules,pustules, and cyst formation which on rupture   cause Vranavastu (scar) formation. Allopathic treatments includes the use of topical retinoids, benzoyl peroxide , oral antibiotics, steroids , and  oral isotretinoin  . Although its use is limited by teratogenicity and other side effects. Ayurveda has a great potential in the management of Acne vulgaris is reported. Two types of Chikitsa are explained in the management of Mukhadushika i.e, Shodhana and Shamanachikitsa. Shodhanachikitsa includes Vaman ,Virechana, Nasya, Jalaukavcharna and Shiravyadha. Shaman Chikitsa includes various type of lepa and oral medication.

           In present study one such formulations of lepa which is given in Sharangdharasamhitauttarkhand 11 /14-15 is Vatapatradi lepa( trial drug ) is taken to assess its efficacy on Mukhadushika w.s.r to Acne vulagaris and compared with Shalmaliadi lepa ( controlled).

·      The word ‘Mukha’ means face or countenance and  Dushika  means face spoiler or eruption that configures the Mukh a(face)  .

 

 

·       The word Mukhadushika  is derived from Mukhamdushayathi Vivarnamkarothi iti Mukhadushika means that which disfigures the  Mukha along with causing discolouarion.


 
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