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CTRI Number  CTRI/2024/01/062102 [Registered on: 31/01/2024] Trial Registered Prospectively
Last Modified On: 26/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Clinical trial to study the effect of face serum prepared by the combination of Vata, Lodhra and Manjishta in Mukhadushika. 
Scientific Title of Study   Clinical trial to evaluate the effect of face Serum in Mukhadushika Prepared by the combination Of Vata, Lodhra and Manjishta. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ragendhu.B 
Designation  Pg scholar 
Affiliation  Amrita School Of Ayurveda 
Address  Omega Maranaloor koovalessary po
Department of Rasashastra and Bhaishajya kalpana Amrita Vishwa Vidyapeetham, Amritapuri,Clappana PO Kerala, India – 690525.
Kollam
KERALA
695512
India 
Phone  8129882509  
Fax    
Email  ragendhuomega8606@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ramesh N V 
Designation  HOD  
Affiliation  Amrita school of ayurveda  
Address  Amrita school of ayurveda Amrita Vishwa Vidyapeetham, Amritapuri,Clappana
Department of Rasashastra and Bhaishajya kalpana Amrita Vishwa Vidyapeetham, Amritapuri, Clappana P.O Kerala, India – 690525.
Kollam
KERALA
690525
India 
Phone  9446962390  
Fax    
Email  rameshnv@ay.amrita.edu  
 
Details of Contact Person
Public Query  
Name  Ragendhu.B 
Designation  Pg scholar 
Affiliation  Amrita school of ayurveda  
Address  Omega Maranaloor koovalessary po
Department of Rasashastra and Bhaishajya kalpana Amrita Vishwa Vidyapeetham, Amritapuri, Clappana P.O Kerala, India – 690 525.
Kollam
KERALA
695512
India 
Phone  8129882509  
Fax    
Email  ragendhuomega8606@gmail.com  
 
Source of Monetary or Material Support  
Amrita school of Ayurveda Amrita Vishwa Vidyapeetham, Amritapuri, Clappana P.O Kerala, India – 690525 
 
Primary Sponsor  
Name  Dr RagendhuB 
Address  Amrita school of Ayurveda  
Type of Sponsor  Other [Self] 
 
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 RagendhuB  Amrita school of Ayurveda  Department of Rasashastra and Bhaishajya kalpana Amrita Vishwa Vidyapeetham, Amritapuri, Clappana P.O.Kerala,India – 690525
Kollam
KERALA 		 8129882509

ragendhuomega8606@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Amrita School Of Ayurveda  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), (2) ICD-10 Condition:L700||Acne vulgaris. Ayurveda Condition: YUVANAPIDAKA (MUKHADUSHIKA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: vata, lodhra, manjishta face serum, Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 3(drops), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 1 Months, Reference: NA, Route: -, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1.Mild to moderate 
 
ExclusionCriteria 
Details  1.PCOS cases
2.History of allergic reaction to topically applied skin care products.
3. Acne caused as a side effect of anabolic steroid use 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The total severity score is derived from summation of six regional sub scores.
Each is derived by multiplying the factors
2 for forehead, 2 for each cheeks, 1 for nose, 1 for chin
3 for both chest and back by the most heavily weighted lesion within each region (1 for≥
one comedone, 2 for ≥ one papule,3 for ≥ one pustule, and 4 for ≥ one nodule)
The score for each area is the product of the most severe lesion, multiplied by the area
factor. These individual scores are then added to obtain the total score.
Mild: (1- 18)
Moderate (19-30) 		 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Face skin parameters using Derma Lab
1.Sebum strip reader
2. TEWL probe
3. Videoscope probe  		 1 month 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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 3 
Date of First Enrollment (India)   10/02/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/02/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
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   Acne vulgaris is a common chronic inflammatory disease of the pilosebaceous unit which is characterized by the formation of non-inflammatory open and closed comedones & inflammatory papules, pustules, nodules, and cysts. Acne vulgaris is a common skin disease affecting more than 85% of adolescents and two-thirds of adults aged 18 years and older. The four main pathogenetic factors that contribute to acne are follicular hyperkeratinization, increased sebum production, Propionibacterium acnes (P. acnes) inside the follicle, and inflammation.. Acne vulgaris can be correlated with mukhadushika based on the symptom, a disease mentioned in kshudraroga. Presently various treatment modalities are adopted for acne which includes anti-inflammatory, antibiotics, and comedolytic agents. However, they are reported to be expensive and with many adverse effects. Lepa works well to treat acne. Practically lepa is difficult to prepare and apply due to stain, smell, fluidity, non-availability of fresh herbs also lack of time. In the present era, there is a demand for potent, easily applicable quick formulations that are in terms of patient convenience, affordability, and less side effects. Face serums have higher concentrations of key ingredients. Properties such as light skincare formulation, thinner in viscosity, and low-density aid in rapid absorption and deeper penetration. Face serum market growing at a compound annual growth rate (CAGR) of 4.8% from 2022 to 2031 Face serum are easy to apply, carry and store.
AIMS AND OBJECTIVES OF THE STUDY AIMS - To evaluate the effect of face serum, prepared by the combination of Vata, Lodra and Manjishta in mukhadushika. OBJECTIVES – 1.Preparation of water-based face serum & analysis of its physicochemical characteristics & phytochemicals 2. To evaluate the clinical efficacy of face serum in acne vulgaris
 
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