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CTRI Number  CTRI/2022/07/044106 [Registered on: 18/07/2022] Trial Registered Prospectively
Last Modified On: 29/06/2022
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   Natural ingredient for acne  
Scientific Title of Study   Randomized open controlled clinical study to evaluate the efficacy of tuvari lepa in the management of mukhdushika(yuvan pidika) with special reference to acne vulgaris 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akash vithalrao rathod 
Designation  PG student kayachikitsa 
Affiliation  Yashwant ayurvedic medical College and research center kodoli 
Address  Room no.17 kayachikitsa department Yashwant ayurvedic medical College and research center kodoli taluka Panhala dist-Kolhapur

Kolhapur
MAHARASHTRA
416114
India 
Phone  9421355528  
Fax    
Email  avr9003@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vd suryakiran wagh 
Designation  PG student kayachikitsa 
Affiliation  Yashwant ayurvedic medical College and research center kodoli 
Address  Room no.17 kayachikitsa department Yashwant ayurvedic medical College and research center kodoli taluka Panhala dist-Kolhapur

Kolhapur
MAHARASHTRA
416114
India 
Phone  9822846910  
Fax    
Email  Suryakiran_wagh@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Vd Suryakiran wagh 
Designation  MD kayachikitsa 
Affiliation  Yashwant ayurvedic medical College and research center kodoli 
Address  Room no.17 Yashwant ayurvedic medical College and research center kodoli taluka Panhala dist-Kolhapur

Kolhapur
MAHARASHTRA
416114
India 
Phone  9822846910  
Fax    
Email  Suryakiran_wagh@rediffmail.com  
 
Source of Monetary or Material Support  
Yashwant ayurvedic medical College and research center kodoli 
 
Primary Sponsor  
Name  Yashwant ayurvedic medical College 
Address  Room no.17 Yashwant ayurvedic medical College and research center kodoli taluka Panhala dist-Kolhapur 416114 
Type of Sponsor  Private medical college 
 
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 
Akash vithalrao rathod  Yashwant ayurvedic medical College and research center kodoli  Room no. 17 Department kayachikitsa Yashwant ayurvedic medical College and research center kodoli taluka Panhala dist-Kolhapur 416114
Kolhapur
MAHARASHTRA 		 9421355528

avr9003@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L700||Acne vulgaris,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Erythromycin Drug Drug route - Topical Dosage form - ointment Frequency - od Duration - 1 months
2Intervention ArmDrugClassical(1) Medicine Name: Tuvari , Reference: Ashtang sangraha uttarsthan 37/5, Route: Topical, Dosage Form: Lepa Churna, Dose: 1(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  32.00 Year(s)
Gender  Both 
Details  Patients having age between 12 years to 32 years are included.
2. Patient diagnosed with mukhdushika
3. No discrimination of Gender, Cast, Religion and economic status.
4. Patients who are not on any treatment of mukhdushika since 1 week. 
 
ExclusionCriteria 
Details  Patients having age below 12 years and above 30 years
Patients having another chronic skin diseases
Patients already on treatment mukhdushika 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Unchanged
Slight improvement
Moderate improvement
Marked improvement
 		 At baseline 7th day , 15th day,30th day 
 
Secondary Outcome  
Outcome  TimePoints 
Reduced the acne,pain and swelling  At baseline 7th day, 15th day , 30th day 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   01/08/2022 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary      The skin is unique in many ways, but no other organ demands so much attention and concern in both states of disease and health. There is huge focus on skin health, with fierce competition to have glowing, clearer, healthier, younger and fresher skin. 
          Appearance is important in our society and influences the way in which we are perceived by others. The skin is the most visible organ of the body and determines, to a large extent, our appearance, with a wide function in social and sexual communication. 1
          Skin diseases have a negative impact on human beings, both in acceptance of their own image and in quality of life. 2
             Mukhdushika is one of various skin diseases explained in Ayurveda. This is a very common disease in adolescence, so it is called as Yuvan pidika.
                      शाल्मलीकंटक प्रख्या कफ मारुत शोणितै:
          जायन्ते पिडका युनां विज्ञेया यां मुखदुषिका (सु.नि.१३/३९) 3
        In mukhdushika there is a kapha, vata, rakta dushti which leads to elevations like shalmali thorn. Mukhdushika is a shudra rog, as described by Acharya Sushruta in Nidan sthana 13 and chikitsa sthana 20 under kshudra rog.
         In Ayurveda, acne vulgaris is corelated with mukhdushika or yuvan pidika under the heading of kshudrarog described by Sushruta. 4
           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. 6 
           As Ayurvedic medicines are very much effective in such skin diseases so the subject has been chosen.
 
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